FDA 21 CFR Part 11: The Definitive Guide

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class="base-main-card__subtitle body-text text-color-text overflow-hidden "> Assistant Professor at ARKA JAIN University●Department of Pharmaceutics●Validation & Qualifiction●SAP●ERP●ALCOA+●DCS●QMS●21CFR Part11●CAPA●CC●Deviation●Presentation & Infographic Designer●Excel,PowerPoint,Word </h4>  <div class="body-text text-color-text-low-emphasis base-main-card__metadata"> Published Oct 20, 2022 </div>  </div> <div class="base-main-card__ctas z-[3] self-center ml-3 babybear:ml-1 babybear:self-start"> <a class="base-main-card__cta btn-sm btn-secondary" href="https://www.linkedin.com/signup/cold-join?session_redirect=%2Fpulse%2Ffda-21-cfr-part-11-definitive-guide-shouvik-mondal&trk=article-ssr-frontend-pulse_publisher-author-card" data-tracking-control-name="article-ssr-frontend-pulse_publisher-author-card" data-tracking-will-navigate> + Follow </a> </div> </div> </div> </section> </header> <div data-test-id="article-content-blocks">  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class="font-[700]">What is 21 CFR Part 11?</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>21 CFR Part 11 is a regulatory framework designed by the FDA to guide drugmakers on how to create, manage, and maintain electronic records and electronic signatures. It also says under what conditions drug makers become eligible for compliance with this regulation.</span> </p> </div>  <div class="flex flex-col mt-2" data-test-id="publishing-image-block" rel="ugc"> <figure> <img alt="No alt text provided for this image" class="lazy-load block w-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQF3mmOuHsTxqQ/article-inline_image-shrink_1500_2232/article-inline_image-shrink_1500_2232/0/1666191955942?e=2147483647&v=beta&t=JcrF94H0nDGmpF4HTqkQlUUCbudPlBrONPXRzgQvXvw">  </figure> </div>  <div class="flex flex-col mt-2" data-test-id="publishing-image-block" rel="ugc"> <figure> <img alt="No alt text provided for this image" class="lazy-load block w-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQHoVyflYjkBvQ/article-inline_image-shrink_1000_1488/article-inline_image-shrink_1000_1488/0/1666192067005?e=2147483647&v=beta&t=1p_j7vZt6rlfml6EpdG1oicWEjoDakILebQZxuZzZ14">  </figure> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>The term comes from Title 21 of the Code of Federal Regulations (CFR). In effect since January 2007, 21 CFR Part 11 governs electronic records and signatures in regulated industries like pharmaceuticals, biotech, medical devices, etc.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Totally, the CFR has 50 titles. Out of them, </span><span class="font-[700]">Title 21</span><span class> deals with food and drugs. Again, Title 21 has 3 chapters.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class> <ol> <li><span class="italic">Chapter I – Food and Drug Administration</span></li> <li><span class="italic">Chapter II – Drug Enforcement Administration</span></li> <li><span class="italic">Chapter III – Office of National Drug Control Policy</span></li> </ol> </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Chapter I includes 3 Subchapters named A, B, C, and so on.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class>SUBPART A - GENERAL PROVISIONS</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.1 Scope</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.2 Implementation</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.3 Definitions</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class>SUBPART B - ELECTRONIC RECORDS</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.10 Controls for closed systems</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.30 Controls for open systems</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.50 Signature Manifestations</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.70 Signature record/linking</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class>SUBPART C - ELECTRONIC SIGNATURES</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.100 General Requirements</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.200 Electronic signature components and controls</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>■ Sec. 11.300 Controls for identification codes/passwords</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class="font-[700]">21 CFR Part 11 Compliance Checklist:</span> </h2> </div>  <div class="flex flex-col mt-2" data-test-id="publishing-image-block" rel="ugc"> <figure> <img alt="No alt text provided for this image" class="lazy-load block w-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQGVxCt42IVbDg/article-inline_image-shrink_1000_1488/article-inline_image-shrink_1000_1488/0/1666192332022?e=2147483647&v=beta&t=tB59MCpjqbY_7Zpc9F0cvkAxfdRTK19KTRhRmqlMKRU">  </figure> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class="font-[700]">SUBPART A - GENERAL PROVISIONS:</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.1 Scope -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>This is the first section of 21 CFR Part 11, and its goal is to establish what this regulation does and when it should be applied. The regulations in 21 CFR Part 11 set forth the criteria under which the FDA considers electronic records and signatures to be trustworthy, dependable, and equivalent to paper-based records. 21 CFR Part 11 applies to records in electronic form that are created, modified, maintained, archived, retrieved, and/or transmitted under any records requirement set forth by the FDA.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.2 Implementation</span><span class> -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>This section explicitly states that medical device companies can use paperless record-keeping systems if they are following this regulation. For medical device companies who wish to transmit electronic records to the FDA, they may do so if they comply with this regulation and if the documentation, they wish to submit is identified in docket No. 92S-0251 as a type of submission that the agency accepts in electronic form.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.3 Definitions -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>The FDA provides definitions for some of the terminology that will be used later in Part 11. One example would be the difference in definitions between closed systems and open systems. A closed system is a record-keeping system where system access is controlled by persons who are responsible for the content of electronic records on the system. In an open system, access is not controlled by persons who are responsible for the contents of the electronic records on the system.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class="font-[700]">SUBPART B - ELECTRONIC RECORDS:</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.10 Controls for closed systems -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>This section sets forth 11 separate and distinct security management requirements for companies that wish to keep electronic records using a closed software system. Some of the requirements include limiting system access to authorized individuals, authority, and device checks to verify the integrity of data and signatures, the establishment of written accountability policies for maintaining system security, and the appropriate validation of the record-keeping system to ensure consistency in its intended performance. The FDA also establishes the audit trail requirements in this section. Companies must maintain appropriate control over systems documentation, including revision and change control procedures to maintain an audit trail that documents change in the system. An audit trail ensures that every activity which happens in the record-keeping system generates a record and can be reviewed later.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.30 Controls for open systems -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Open systems typically mean that more people have access to the record-keeping system, so the security requirements should be slightly more comprehensive to help ensure that the records kept are accurate and reliable. This section recommends that open systems are subject to the same 11 security requirements as closed systems, along with any additional appropriate measures such as document encryption and the use of digital signature standards to ensure the integrity and confidentiality of the records.</span> </p> </div> <div class="inline-articles bg-color-surface-new border-hidden rounded-sm p-1 mx-auto my-1.5 mamabear:w-2/3 inline-articles__after"> <h2 class="text-xl font-medium ml-1.5 my-1 text-color-text mamabear:text-center">Recommended by LinkedIn</h2> <div class="flex flex-wrap mx-0.5 babybear:mx-1.5"> <div class="content-author-card flex flex-col max-w-[270px] h-auto rounded-md border-1 border-system-gray-30 border-solid pb-1.5 inline-article mx-auto my-1 border-hidden papabear:w-[219px] babybear:min-w-full mamabear:min-w-full h-auto bg-color-canvas-tint"> <a class="no-underline" data-tracking-control-name="inline-recommended-articles" data-tracking-will-navigate href="https://www.linkedin.com/pulse/rules-writing-common-technical-document-quality-module-edward-narke-kqjbc"> <img class="content-image w-full h-[150px] bg-cover rounded-t-md object-cover" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQF85Y99IouFPg/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1726539807576?e=2147483647&v=beta&t=HVF8eZpo8GyjWKcorpVD5stX1rKadWpmvzgZUSjmAoE"> <div class="inline-article-title text-md text-color-text font-bold pl-2 pt-1 pr-1.5">Rules for Writing the Common Technical Document…</div> <div class="inline-article-meta px-2 mt-1 font-sans text-xs font-normal text-color-text-low-emphasis h-full"> <span class="inline-article-author pt-0.5"> Edward Narke </span> <span class="before:middot pt-0.5 inline-article-published-date"> 2 months ago </span> </div> </a>  </div> <div class="content-author-card flex flex-col max-w-[270px] h-auto rounded-md border-1 border-system-gray-30 border-solid pb-1.5 inline-article mx-auto my-1 border-hidden papabear:w-[219px] babybear:min-w-full mamabear:min-w-full h-auto bg-color-canvas-tint"> <a class="no-underline" data-tracking-control-name="inline-recommended-articles" data-tracking-will-navigate href="https://www.linkedin.com/pulse/key-updates-from-regulatory-authorities-industry-cencorapharmalex-zclcc"> <img class="content-image w-full h-[150px] bg-cover rounded-t-md object-cover" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQEWMRlYYdzkHg/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1725437667093?e=2147483647&v=beta&t=0AKbElZ7K5QyIMq2K1NWzLwoaRu6Kp5NrYGOXDf1P_k"> <div class="inline-article-title text-md text-color-text font-bold pl-2 pt-1 pr-1.5">Key updates from the regulatory authorities and…</div> <div class="inline-article-meta px-2 mt-1 font-sans text-xs font-normal text-color-text-low-emphasis h-full"> <span class="inline-article-author pt-0.5"> PharmaLex </span> <span class="before:middot pt-0.5 inline-article-published-date"> 2 months ago </span> </div> </a>  </div> <div class="content-author-card flex flex-col max-w-[270px] h-auto rounded-md border-1 border-system-gray-30 border-solid pb-1.5 inline-article mx-auto my-1 border-hidden papabear:w-[219px] babybear:min-w-full mamabear:min-w-full h-auto bg-color-canvas-tint"> <a class="no-underline" data-tracking-control-name="inline-recommended-articles" data-tracking-will-navigate href="https://www.linkedin.com/pulse/summary-product-characteristics-spcsmpc-introduction-dr-aditi"> <img class="content-image w-full h-[150px] bg-cover rounded-t-md object-cover" data-delayed-url="https://media.licdn.com/dms/image/v2/C5612AQHhUhvMTtqyGw/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1611083030963?e=2147483647&v=beta&t=pC_Efp8zJa6uaH7YQb6oX3KjMunVBKU6OnP6Dj7Jzvw"> <div class="inline-article-title text-md text-color-text font-bold pl-2 pt-1 pr-1.5">Summary of Product Characteristics (SPC/SmPC):…</div> <div class="inline-article-meta px-2 mt-1 font-sans text-xs font-normal text-color-text-low-emphasis h-full"> <span class="inline-article-author pt-0.5"> Dr. Aditi Sheth (अदिति शेठ) MBBS 🏳️🌈🇮🇳📚 </span> <span class="before:middot pt-0.5 inline-article-published-date"> 3 years ago </span> </div> </a>  </div> </div> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.50 Signature Manifestations -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>This section deals with how signatures should appear on electronic records. The FDA expects to see the printed name of the signer, the date and time that the signature was executed, and the meaning of the signature (approval, review, authorship, etc.) subjected to the same controls as the records themselves and included on any human readable form of the electronic record.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.70 Signature record/linking -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>A section so short, we can quote it: Electronic signatures and handwritten signatures executed to electronic records shall be linked to their respective electronic records to ensure that the signatures cannot be excised, copied, or otherwise transferred to falsify an electronic record by ordinary means.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class="font-[700]">SUBPART C - ELECTRONIC SIGNATURES:</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.200 Electronic signature components and controls -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>The FDA wants electronic signatures to use at least two identifying components - such as including an identification code and a password. Electronic signatures should be assigned to individual persons - not to groups or departments - such that each electronic signature can only be executed by a single person to whom it is assigned and whose identity was verified in compliance with this part. The FDA really wants to make sure that approval and review signatures cannot be disputed once they are entered into the system.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.300 Controls for identification codes/passwords -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>21 CFR Part 11 requires special security measures for the control of passwords. No two individuals should use the same identification/ password to access the system, and passwords should be changed periodically to protect against password aging. Medical device companies must establish transaction safeguards that prevent the unauthorized use of passwords. Loss management procedures should be established to ensure that compromised security tokens, cards, or other devices are deauthorized to prevent security breaches.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class="font-[700]">Sec. 11.100 General Requirements -</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>This section sets forth some of the requirements for personal accountability in electronic signatures that are central to this regulation. It requires organizations to verify the identity of any individual who is assigned an electronic signature on the system and that medical device companies who wish to use electronic signatures must notify the FDA in writing by mail. The agency’s Rockville, MD address is provided. Sec. 11.200 Electronic signature components and controls - The FDA wants electronic signatures to use at least two identifying components - such as including an identification code and a password. Electronic signatures should be assigned to individual persons - not to groups or departments - such that each electronic signature can only be executed by a single person to whom it is assigned and whose identity was verified in compliance with this part. The FDA really wants to make sure that approval and review signatures cannot be disputed once they are entered into the system.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <br> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h2 data-test-id="pulse-publishing-h1"> <span class="font-[700]">Frequently Asked Questions and Answers</span> </h2> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>What is 21 CFR Part 11 compliance?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Any regulated information generated, accessed, stored, modified, or transferred; 21 CFR Part 11 compliance is required. It means you must satisfy the FDA’s regulations in terms of managing your electronic records and electronic signatures.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>How to decide if we require compliance with 21 CFR Part 11?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>The best way to decide is to:</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class> <ol> <li><span class>Create an assessment form as a question-answer sheet.</span></li> <li><span class>Attach this form as an Annexure to the relevant SOP.</span></li> <li><span class>Put key questions in the form. Answers should be “Yes or No”.</span></li> <li><span class>If any of the answers is “Yes”, you need to comply with 21 CFR Part 11.</span></li> <li><span class>The recorded form is now documented evidence of your decision. So, maintain this record for inspections.</span></li> </ol> </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>Shall we customize the Audit Trail Reports?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>You may find pre-formatted custom audit reports built into the system. Each moment of access (log-in, log-out, lock-out, activities) should be recorded and reported in an easy-to-understand format. The FDA may view these records during the inspection and that’ll help them quickly find what they are looking for. Keeping audit trails in raw format will waste your as well as the auditor’s time.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>Part 11 doesn’t talk about lock-out, log-out? Why?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Some best practices automation experts use:</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class> <ol> <li><span class>Automatically log-out the user after 5-10 mins. of inactivity.</span></li> <li><span class>System locks out the user after 3 failed password attempts and if the user is continuously inactive for specific days.</span></li> <li><span class>Setting up password complexity. At least, 1 Capital, 1 Special Character, 8 Characters, 1 Number etc.</span></li> </ol> </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>You see, the regulations don’t mention these. But they do communicate one thing. Consider additional controls to make your systems more secure. That’s why right interpretation is the key to compliance.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>We do every activity on paper. Shall we comply with 21 CFR Part 11?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Simply No. However, there are instances when electronically generated reports like test reports, trends, etc. that are printed and then ink-signed. For such instances, you need to have a documented rationale for not considering 21 CFR Part 11.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>It also applies to the paper records being shared electronically, uploaded on QMS, e-mails, etc. So, you probably don’t know but with such things, you may unknowingly become eligible to comply with 21 CFR Part 11.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>That’s why you see above an Assessment checklist to find out whether you need to comply with the regulation.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>How E-sign can be linked to a document?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>Signs must be encrypted with a private key assigned to each signer. Such digital signatures are considered safe and secure. Following are the non-compliances.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class> <ol> <li><span class>Scanning the signature and putting it into the record.</span></li> <li><span class>Screenshot manipulation of the physical signature.</span></li> </ol> </span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>These are violations under section 11.70 which interprets as “</span><span class="italic">If an electronic record is signed (ink or electronic), the signature must remain associated with the record. No action can be taken to erase, copy, or transfer it.</span><span class>“</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <h3><span class>How to Validate Electronic Systems under 21 CFR Part 11?</span></h3> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class>For this, the FDA recommends reading the following references.</span> </p> </div>  <div class="article-main__content" data-test-id="publishing-text-block"> <p> <span class> <ol> <li><span class><a href="https://www.linkedin.com/redir/redirect?url=https%3A%2F%2Fwww%2Efda%2Egov%2Fmedia%2F73141%2Fdownload&urlhash=l757&trk=article-ssr-frontend-pulse_little-text-block" target="_blank" data-tracking-control-name="article-ssr-frontend-pulse_little-text-block" data-tracking-will-navigate data-test-link>General Principles of Software Validation; Final Guidance for Industry and FDA Staff </a></span></li> <li><span class><a href="https://www.linkedin.com/redir/redirect?url=https%3A%2F%2Fispe%2Eorg%2Fgamp-resources&urlhash=JwgU&trk=article-ssr-frontend-pulse_little-text-block" target="_blank" data-tracking-control-name="article-ssr-frontend-pulse_little-text-block" data-tracking-will-navigate data-test-link>The Good Automated Manufacturing Practice (GAMP) Guide for Validation of Automated Systems, GAMP 4 (ISPE/GAMP Forum, 2001) </a></span></li> </ol> </span> </p> </div>  </div>   </article> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link main-publisher-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/newsletters/insight-with-shouvik-mondal-6931657415612346368" data-tracking-will-navigate> <span class="sr-only"> INSIGHT With SHOUVIK MONDAL </span> </a> <img class="inline-block relative w-6 h-6 " 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data-singular="%numComments% Comment" data-plural="%numComments% Comments" data-entity-urn="urn:li:ugcPost:6988699079098736640"> 5 Comments </a>  </div> </div> </div> <div class="comments__container"> <div class="comments">   <section class="comment flex grow-1 items-stretch leading-[16px] comment-with-action my-1.5"> <div> <a href="https://ie.linkedin.com/in/niall-orourke?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-image" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-image" data-tracking-will-navigate> <img class="inline-block relative rounded-[50%] w-4 h-4 bg-color-entity-ghost-background" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9c8pery4andzj6ohjkjp54ma2" data-ghost-classes="bg-color-entity-ghost-background" data-ghost-url="https://static.licdn.com/aero-v1/sc/h/9c8pery4andzj6ohjkjp54ma2" alt="Niall O'Rourke"> </a> </div> <div class="w-full min-w-0"> <div class="comment__body ml-0.5 mb-1 pt-1 pr-1.5 pb-1 pl-1.5 rounded-[8px] rounded-tl-none relative"> <div class="comment__header flex flex-col"> <a class="text-sm link-styled no-underline leading-open comment__author truncate pr-6" href="https://ie.linkedin.com/in/niall-orourke?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-will-navigate> Niall O'Rourke </a> <p class="!text-xs text-color-text-low-emphasis leading-[1.33333] mb-0.5 truncate comment__author-headline">CSV Lead & Software Dev - protonglow.com | part11compliance.com</p> <span class="text-xs text-color-text-low-emphasis comment__duration-since absolute right-6 top-1 inline-block"> 1mo </span> <div class="ellipsis-menu absolute right-0 top-0 !mr-0.5 babybear:!-top-0.5" data-test-id="comment__ellipsis-menu" data-feed-action="show-comment-dropdown"> <div class="collapsible-dropdown flex items-center relative hyphens-auto"> <button class="ellipsis-menu__trigger collapsible-dropdown__button btn-md btn-tertiary cursor-pointer !py-[6px] !px-1 flex items-center rounded-[50%] ellipsis-menu__trigger--small w-[32px] h-[32px] babybear:rotate-90 mamabear:!h-4 mamabear:!min-h-[32px] papabear:!h-4 papabear:!min-h-[32px]" aria-expanded="false" aria-label="Open menu" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_ellipsis-menu-trigger" tabindex="0"> <icon class="ellipsis-menu__trigger-icon m-0 p-0 centered-icon" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/c26vw8uiog92lvrqov98hvbxr"></icon> </button> <ul class="collapsible-dropdown__list hidden container-raised absolute w-auto overflow-y-auto flex-col items-stretch z-1 bottom-auto top-[100%]" role="menu" tabindex="-1"> <li class="ellipsis-menu__item border-t-1 border-solid border-color-border-low-emphasis first-of-type:border-none flex"> <a href="/uas/login?session_redirect=https%3A%2F%2Fwww.linkedin.com%2Fpulse%2Ffda-21-cfr-part-11-definitive-guide-shouvik-mondal&trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_ellipsis-menu-semaphore-sign-in-redirect&guestReportContentType=COMMENT&_f=guest-reporting" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_ellipsis-menu-semaphore-sign-in-redirect" data-tracking-will-navigate data-item-type="semaphore" data-semaphore-content-type="COMMENT" data-semaphore-content-urn="urn:li:comment:(urn:li:ugcPost:6988699079098736640,7250557783291432960)" data-semaphore-tracking-prefix="article-ssr-frontend-pulse_x-social-details_comments-action_comment_ellipsis-menu-semaphore" data-is-logged-in="false" data-modal="semaphore__toggle" class="semaphore__toggle visited:text-color-text-secondary ellipsis-menu__semaphore ellipsis-menu__item-button flex items-center w-full p-1 cursor-pointer font-sans text-sm font-bold link-styled focus:link-styled link:no-underline active:bg-color-background-container-tint focus:bg-color-background-container-tint hover:bg-color-background-container-tint outline-offset-[-2px]">  <icon class="ellipsis-menu__item-icon text-color-text h-[24px] w-[24px] mr-1" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/iq0x9q37wj214o129ai1yjut"> </icon> Report this comment </a>  </li>  </ul>  </div> </div> </div> <div class="attributed-text-segment-list__container relative mt-1 mb-1.5 babybear:mt-0 babybear:mb-0.5"> <p class="attributed-text-segment-list__content text-color-text !text-sm whitespace-pre-wrap break-words comment__text babybear:mt-0.5" dir="ltr">I wrote this book called a “Practical Guide to 21 CFR Part 11”. It dives deep into the technical side. <a class="link" href="https://www.amazon.com/gp/aw/d/1739677773/ref=tmm_pap_swatch_0?ie=UTF8&dib_tag=se&dib=eyJ2IjoiMSJ9.wh3kZ0Em1nVbfOxTbz1JfA.j4aq-wTmRqK6mZOFzsJFBY0Z1IJNK4m-Co2afDPDBnw&qid=1728667032&sr=8-1&trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment-text" target="_self" rel="nofollow" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment-text" data-tracking-will-navigate>https://www.amazon.com/gp/aw/d/1739677773/ref=tmm_pap_swatch_0?ie=UTF8&dib_tag=se&dib=eyJ2IjoiMSJ9.wh3kZ0Em1nVbfOxTbz1JfA.j4aq-wTmRqK6mZOFzsJFBY0Z1IJNK4m-Co2afDPDBnw&qid=1728667032&sr=8-1</a></p>  </div>   </div> <div class="comment__actions flex flex-row flex-wrap items-center ml-2" aria-label="Comment Controls"> <a 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href="https://www.linkedin.com/signup/cold-join?session_redirect=%2Fpulse%2Ffda-21-cfr-part-11-definitive-guide-shouvik-mondal&trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_reply" class="comment__action inline-block font-sans text-xs text-color-text-low-emphasis cursor-pointer comment__reply" data-feed-action="replyToComment" data-feed-control="reply" data-feed-action-category="EXPAND" data-feed-action-type="expandReplyBox" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_reply" data-tracking-will-navigate> <div class="flex flex-row items-center "> <icon class="action-btn__icon w-2 mr-0.5" data-svg-class-name="action-btn__icon--svg" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/4ol9mo4lxvobj5ww3va90wz1o"> </icon> <span class="action-btn__button-text inline-block align-baseline"> Reply </span> </div> </a>  <span class="comment__reactions-count font-sans text-xs text-color-text-low-emphasis border-l-1 border-solid border-color-border-low-emphasis pl-1 mx-1 hidden"> 1 Reaction </span> </div> </div> </section>  <section class="comment flex grow-1 items-stretch leading-[16px] comment-with-action my-1.5"> <div> <a href="https://in.linkedin.com/in/monika-dhande-56326b221?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-image" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-image" data-tracking-will-navigate> <img class="inline-block relative rounded-[50%] w-4 h-4 " data-delayed-url="https://media.licdn.com/dms/image/v2/D5603AQEL8n19gZiDyQ/profile-displayphoto-shrink_400_400/profile-displayphoto-shrink_400_400/0/1700834293588?e=2147483647&v=beta&t=c0-5YRXameamalQcj50NWyPijB3sfcg2TlC07i223tk" data-ghost-classes="bg-color-entity-ghost-background" data-ghost-url="https://static.licdn.com/aero-v1/sc/h/9c8pery4andzj6ohjkjp54ma2" alt="Monika Dhande"> </a> </div> <div class="w-full min-w-0"> <div class="comment__body ml-0.5 mb-1 pt-1 pr-1.5 pb-1 pl-1.5 rounded-[8px] rounded-tl-none relative"> <div class="comment__header flex flex-col"> <a class="text-sm link-styled no-underline leading-open comment__author truncate pr-6" href="https://in.linkedin.com/in/monika-dhande-56326b221?trk=article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-will-navigate> Monika Dhande </a> <p class="!text-xs text-color-text-low-emphasis leading-[1.33333] mb-0.5 truncate comment__author-headline">Officer in Quality Control Department at Leben Life Sciences Ltd</p> <span class="text-xs text-color-text-low-emphasis comment__duration-since absolute right-6 top-1 inline-block"> 2y </span> <div class="ellipsis-menu absolute right-0 top-0 !mr-0.5 babybear:!-top-0.5" data-test-id="comment__ellipsis-menu" data-feed-action="show-comment-dropdown"> <div 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data-tracking-control-name="article-ssr-frontend-pulse_x-social-details_comments-action_comment_actor-name" data-tracking-will-navigate> Pretam A S. </a> <p class="!text-xs text-color-text-low-emphasis leading-[1.33333] mb-0.5 truncate comment__author-headline">Global PV Agreements at Teva | Aspiring Associate Director | Certified PV Auditor (CRQA) | Compliance | PV Educator | AI Enthusiast | Content Creator |</p> <span class="text-xs text-color-text-low-emphasis comment__duration-since absolute right-6 top-1 inline-block"> 2y </span> <div class="ellipsis-menu absolute right-0 top-0 !mr-0.5 babybear:!-top-0.5" data-test-id="comment__ellipsis-menu" data-feed-action="show-comment-dropdown"> <div class="collapsible-dropdown flex items-center relative hyphens-auto"> <button class="ellipsis-menu__trigger collapsible-dropdown__button btn-md btn-tertiary cursor-pointer !py-[6px] !px-1 flex items-center rounded-[50%] ellipsis-menu__trigger--small w-[32px] h-[32px] babybear:rotate-90 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class="show-more-less">  <ul data-max-num-to-show="4" class="show-more-less__list show-more-less__list--hide-after-4" data-impression-id="article-ssr-frontend-pulse_show-more-less"> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/why-do-we-use-sodium-thiosulfate-sts-raw-water-analysis-mondal-jzbyc" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> Why do we use Sodium Sodium thiosulfate (STS) for raw water analysis? </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQGQPqm6AAetrA/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1723181079580?e=2147483647&v=beta&t=v2zijKvabmyRcwbHJkw3sJug6YWKvNGwL1v5S599Z1Y" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Aug 9, 2024</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> Why do we use Sodium Sodium thiosulfate (STS) for raw water analysis? </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> How chlorine affected the analysis: The residual chlorine can interface with the microbial analysis of water. These… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="18 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="18" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 18 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="1" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 1 Comment </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/why-did-we-use-045-micron-filter-rather-than-02-water-shouvik-mondal-jclmc" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> Why did we use a 0.45 micron filter rather than a 0.2 micron filter for water analysis ? </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQFjzhPGui584w/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1723109651288?e=2147483647&v=beta&t=T7Z7RVOc3KzPbrirGiHBwgfF-9wdgRHdRf89r1a53qY" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Aug 8, 2024</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> Why did we use a 0.45 micron filter rather than a 0.2 micron filter for water analysis ? </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> 1. Effectively filtering out: For water analysis, a 0. </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="44 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="44" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <img alt data-reaction-type="INTEREST" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/4v7dh2d6cuqm24mzps1pqzeqt" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 44 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="4" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 4 Comments </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/10-most-expensive-fda-approved-drugs-2023-shouvik-mondal-p9lyc" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> 10 Most Expensive FDA approved Drugs 2023 </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQH-b4YBMjrsnQ/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1703994991546?e=2147483647&v=beta&t=GKs_1nziyMgVEI06PDxM6enGsL8OIqCknDBa52g0BSA" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Dec 31, 2023</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> 10 Most Expensive FDA approved Drugs 2023 </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> 1️⃣ Hemgenix (etranacogene dezaparvovec): Gene therapy that introduces a functional gene into the body. This enables… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="38 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="38" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 38 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/shouvik-mondal" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> 𝗪𝗵𝘆 𝗱𝗼 𝘄𝗲 𝗲𝘅𝗽𝗼𝘀𝗲 𝗺𝗲𝗱𝗶𝗮 𝗽𝗹𝗮𝘁𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗮𝗿𝗲𝗮 𝗳𝗼𝗿 𝟰 𝗵𝗼𝘂𝗿𝘀? </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D4D12AQFJdNQdPLIUgQ/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1697509035254?e=2147483647&v=beta&t=tkU-2KJOZMPHMVW6fVWas85Jn9cujHjJBowXGaK7VJY" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Oct 17, 2023</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> 𝗪𝗵𝘆 𝗱𝗼 𝘄𝗲 𝗲𝘅𝗽𝗼𝘀𝗲 𝗺𝗲𝗱𝗶𝗮 𝗽𝗹𝗮𝘁𝗲𝘀 𝗶𝗻 𝘁𝗵𝗲 𝗰𝗹𝗲𝗮𝗻𝗿𝗼𝗼𝗺 𝗮𝗿𝗲𝗮 𝗳𝗼𝗿 𝟰 𝗵𝗼𝘂𝗿𝘀? </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> Media plates are exposed in the main areas of activity and positioned to capture the maximum amount of particles. Large… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="30 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="30" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 30 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="1" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 1 Comment </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/different-types-batch-records-pharmaceutical-industry-shouvik-mondal" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> Different Types of Batch Records in Pharmaceutical Industry </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D4D12AQGdjJaZ-z5JdQ/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1691120979882?e=2147483647&v=beta&t=8xV3da8TwFXTxdbPWmg86ZjT_yrFf25RIIiNr0v4lkI" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Aug 7, 2023</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> Different Types of Batch Records in Pharmaceutical Industry </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> 1. Master Batch Record (MBR): This is a comprehensive document that provides detailed instructions for the… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="78 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="78" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <img alt data-reaction-type="APPRECIATION" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/cib97epu77mrzque5gqlzjgaw" height="16px" width="16px"> <img alt data-reaction-type="EMPATHY" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/37hg81qnm85dsy5mbqfifg9qs" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 78 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="7" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 7 Comments </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/qualification-validation-pharmaceutical-manufacturing-shouvik-mondal" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> Qualification And Validation In Pharmaceutical Manufacturing </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D4D12AQEoHdi9MB2tAw/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1685370385377?e=2147483647&v=beta&t=HjL1Dn1v1DO_l454IKsROfZmkP6_HLlNIWy9sKqyvKQ" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">May 30, 2023</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> Qualification And Validation In Pharmaceutical Manufacturing </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> 1. WHAT IS VALIDATION? EU GMP - it is “Action of proving, in accordance with the principles of Good Manufacturing… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="60 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="60" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 60 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="3" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 3 Comments </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/can-we-use-expired-raw-materials-manufacture-drug-shouvik-mondal" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> Can We Use Expired Raw Materials to Manufacture Drug Formulations? </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D5612AQExBGqCdW9yXg/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1671375048565?e=2147483647&v=beta&t=8ByPfskhSxjwNcLULAM9WM5xry2LPTXhID06cR28beE" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Dec 19, 2022</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> Can We Use Expired Raw Materials to Manufacture Drug Formulations? </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> 1. What is an Active Pharmaceutical Ingredient? An active Pharmaceutical Ingredient (API) is any substance or mixture… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="65 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="65" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 65 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="9" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 9 Comments </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" href="https://www.linkedin.com/pulse/usfda-top-10-observations-form-483-trend-last-8-years-shouvik-mondal" data-tracking-control-name="article-ssr-frontend-pulse" data-tracking-will-navigate> <span class="sr-only"> USFDA Top 10 Observations (Form 483) trend of last 8 years for Pharmaceutical Industries </span> </a> <div class="base-main-card__media relative w-[228px] block overflow-hidden flex-shrink-0 rounded-md h-[129px] babybear:w-[105px] babybear:h-[59px]"> <img class="h-full" data-delayed-url="https://media.licdn.com/dms/image/v2/D4E12AQGHvuXbTFByQw/article-cover_image-shrink_720_1280/article-cover_image-shrink_720_1280/0/1670945395237?e=2147483647&v=beta&t=-tVDw5IUPHgqUtOvn8ExH-2ao2avz5-k9bLWSayoPX8" alt>  </div> <div class="base-main-card__info self-center ml-1 flex-1 relative break-words papabear:min-w-0 mamabear:min-w-0 babybear:w-full article-card-social-actions"> <div class="body-text text-color-text-low-emphasis base-main-card__metadata mb-0 babybear:mb-0 babybear:-mt-0.5"> <span class="body-text text-color-text-low-emphasis base-main-card__metadata-item babybear:text-xs">Dec 14, 2022</span>  </div> <h3 class="base-main-card__title font-sans text-[18px] font-bold text-color-text overflow-hidden babybear:text-sm"> USFDA Top 10 Observations (Form 483) trend of last 8 years for Pharmaceutical Industries </h3>  <p class="base-main-card__description body-text text-color-text -mt-0.5"> BACKGROUND: This short review summarizes analysis and trending on top 10 inspectional observations called FORM -483… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="78 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="78" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <img alt data-reaction-type="MAYBE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/4iy169rwfs5rdhspekg2r5wc6" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" data-test-id="social-actions__reaction-count"> 78 </span> </div> <code id="social-actions__reaction-image-APPRECIATION" style="display: none"></code>  <code id="social-actions__reaction-image-EMPATHY" style="display: none"></code> <code id="social-actions__reaction-image-ENTERTAINMENT" style="display: none"></code>  <code id="social-actions__reaction-image-INTEREST" style="display: none"></code> <code id="social-actions__reaction-image-LIKE" style="display: none"></code> <code id="social-actions__reaction-image-MAYBE" style="display: none"></code> <code id="social-actions__reaction-image-PRAISE" style="display: none"></code>  <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis before:middot my-1" data-separate-ctas="false" data-test-id="social-actions__comments" data-id="social-actions__comments" data-num-comments="6" data-singular="%numComments% Comment" data-plural="%numComments% Comments"> 6 Comments </div>  </div> </div>  </div> </li> <li> <div class="base-card relative w-full hover:no-underline focus:no-underline base-card--link base-main-card flex flex-wrap py-2 pr-2 babybear:pr-0 base-main-card--link babybear:py-1 main-article-card"> <a class="base-card__full-link absolute top-0 right-0 bottom-0 left-0 p-0 z-[2]" 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We need extraordinary control to… </p>  <code id="i18n_reaction_singular" style="display: none"></code> <code id="i18n_reactions_plural" style="display: none"></code> <div class="flex items-center font-sans text-sm babybear:text-xs -mt-1"> <div class="flex items-center font-normal text-color-text-low-emphasis no-underline visited:text-color-text-low-emphasis my-1" role="button" aria-label="19 Reactions" data-separate-ctas="false" data-test-id="social-actions__reactions" data-id="social-actions__reactions" data-num-reactions="19" data-singular="%numReactions%" data-plural="%numReactions%" tabindex="0"> <img alt data-reaction-type="LIKE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/9sun4diznbhgyelaeryxy75ur" height="16px" width="16px"> <img alt data-reaction-type="PRAISE" data-delayed-url="https://static.licdn.com/aero-v1/sc/h/cjrxeu0ese8oxe32kiom8kzoh" height="16px" width="16px"> <span aria-hidden="true" class="font-normal ml-0.5" 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FDA 21 CFR Part 11: The Definitive Guide