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class="tabs"></div> <div class="region region-content"> <div id="block-system-main" class="block block-system"> <div class="content"> <div id="node-1536" class="node node-page slider-secondary clearfix" about="/21-cfr-part-11-compliance" typeof="sioc:Item foaf:Document"> <span property="dc:title" content="21 CFR Part 11 Compliance" class="rdf-meta element-hidden"></span><span property="sioc:num_replies" content="0" datatype="xsd:integer" class="rdf-meta element-hidden"></span> <div class="content"> <div class="field field-name-field-last-revised field-type-datetime field-label-inline inline"><div class="field-label">Last revised<span class="colon">:</span> </div><div class="field-items"><div class="field-item even"><span property="dc:date" datatype="xsd:dateTime" content="2017-09-12T00:00:00-07:00" class="date-display-single">09/12/2017</span></div></div></div><div class="field field-name-field-body field-type-text-long field-label-hidden"><div class="field-items"><div class="field-item even"><p>If your research is being conducted under an approved IND or IDE, the computer systems used to collect and analyze data must be validated to meet the FDA requirements for electronic records and signatures. Whether you are purchasing all or part of a system from a vendor or using your own system using university resources, you are responsible for demonstrating that the system meets 21 CFR Part 11.</p> <ul> <li><a href="https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-drugs-gen/documents/document/ucm563785.pdf">Use of Electronic Records and Electronic Signatures in Clinical Investigations Under 21 CFR Part 11 -- Questions and Answers (June 2017)</a></li> <li><a href="http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm">21 CFR Part 11 Electronic Records and Signatures (August 2003)</a></li> <li><a href="http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm085281.htm">General Principles of Software Validation; Guidance for Industry and FDA Staff (January 2002) </a></li> <li><a href="http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=11">21 CFR Part 11 Regulatory Documents</a></li> </ul> <p><strong>Key Concepts About 21 CFR Part 11, Electronic Records and Signatures</strong></p> <ul> <li>When you automate collection, processing, and analysis of research information, you are creating an <strong><em>electronic record</em></strong>. 21 CFR Part 11 exists to give the agency assurance that electronic records are the same as paper records.</li> <li>When you automate the process of an individual authorizing an action, you have created an <strong><em>electronic signature</em></strong>. In addition to the controls required for electronic records, 21 CFR Part 11 contains requirements to assure the agency that electronic signatures are the legally binding equivalent of a person’s handwritten signature.</li> <li>Access control determines whether a system is <strong><em>open </em></strong>or <strong><em>closed</em></strong>. If the persons responsible for the content of electronic records also have control of system access, the system is ‘closed’. If the persons responsible for content of electronic records do not have control of system access, the system is ‘open’. Open systems require the added assurance that records are protected from point of creation to receipt.</li> <li>You can use electronic records in lieu of paper records with one caveat – <strong><em>only a subset of records required for pre-market approval are accepted by the agency</em></strong>. Accepted documents are listed in public docket <strong><u>No. 92S-0251</u></strong>. All other records required to be kept, but not submitted, can be in electronic form. In all cases, to be valid, you must comply with 21 CFR Part 11.</li> <li>Track activities and define your needs; employ a combination of procedural and technical controls for development and operation of the system; verify and certify that everything works; and document what you’ve done.</li> <li>Validation effort for medical device software must be commensurate with the <strong><em>level of concern for the device</em></strong>. There are three levels of concern:</li> </ul> <p style="margin-left: 40px;"><strong><em>Major</em></strong> – operation could result in death or serious injury</p> <p style="margin-left: 40px;"><strong><em>Moderate</em></strong> – operation could result in non-serious injury</p> <p style="margin-left: 40px;"><strong><em>Minor</em></strong> – operation not expected to result in any injury</p> <p> </p> </div></div></div> </div> </div> </div> </div> </div> </div> </div> <div id="sidebar" class="column"> <div class="sidebar"> <div class="section"> <div class="region region-sidebar"> <div id="block-menu-block-3" class="block block-menu-block"> <h3><a href="/21-cfr-part-11-compliance" class="active-trail active">21 CFR Part 11 Compliance</a></h3> <div class="content"> <div class="menu-block-wrapper menu-block-3 menu-name-main-menu parent-mlid-0 menu-level-3"> <ul class="menu"><li class="first leaf menu-mlid-2406"><a href="/system-validation">System Validation</a></li> <li class="leaf menu-mlid-2136"><a href="/procedural-controls">Procedural Controls</a></li> <li class="leaf menu-mlid-2456"><a href="/technical-controls">Technical Controls</a></li> <li class="leaf menu-mlid-2361"><a href="/verification">Verification</a></li> <li class="last leaf menu-mlid-2151"><a href="/systems-documentation">Systems Documentation</a></li> </ul></div> </div> </div> </div> </div> </div> </div> </div></div> <div id="footer"> <div class="section"> <div class="region region-footer"> <div id="block-block-6" class="block block-block"> <div class="content"> <style type="text/css"> <![CDATA[/* ><!]]>*/ </style> <div class="quickref"> <h2 style="color:#000;font-size:22px;margin:0;padding: 0 0 6px;">Quick Reference</h2> <div class="wysiwyg_threecols layout--33-33-33"> <div class="wysiwyg_threecols--first"> <ul> <li><a href="http://policies.ucsf.edu/" target="_blank">Campus Policies</a></li> <li><a href="http://cancer.ucsf.edu/" target="_blank">Cancer Center (HDFCCC)</a></li> <li><a href="http://accelerate.ucsf.edu/research/crs" target="_blank">Clinical Research Services</a></li> <li><a href="http://ctsi.ucsf.edu" target="_blank">Clinical & Translational Science Institute (CTSI)</a></li> </ul> </div> <div class="wysiwyg_threecols--second"> <ul> <li><a href="http://coi.ucsf.edu/" target="_blank">Conflicts of Interest (COI)</a></li> <li><a href="http://accelerate.ucsf.edu/consult" target="_blank">Consultation Services</a></li> <li><a href="http://accelerate.ucsf.edu/cores/" target="_blank">Cores Search</a></li> <li><a href="https://ehs.ucsf.edu/" target="_blank">Environment, Health and Safety</a></li> <li><a href="http://compliance.ucsf.edu/" target="_blank">Ethics & Compliance</a></li> </ul> </div> <div class="wysiwyg_threecols--third"> <ul> <li><a href="http://globalhealthsciences.ucsf.edu/" target="_blank">Global Health Sciences</a></li> <li><a href="http://ita.ucsf.edu/" target="_blank">Innovation, Technology & Alliances</a></li> <li><a href="http://irb.ucsf.edu" target="_blank">IRB / Human Research Protection Program</a></li> <li><a href="https://osr.ucsf.edu/" target="_blank">Office of Sponsored Research</a></li> <li><a href="http://profiles.ucsf.edu" target="_blank">UCSF Profiles</a></li> </ul> </div> </div> </div> <p style="float: right; margin: 1.2em 30px -1.5em; text-align: right; width: 6em;"><a href="/cdn-cgi/l/email-protection#bdf5e8fffdc8decedb93d8d9c8" style="color:#FFF"><span class="__cf_email__" data-cfemail="5c14091e1c293f2f3a72393829">[email protected]</span></a></p> </div> </div> </div> <div class="footer-bottom"> <nav aria-label="Footer Navigation" class="footer--navigation"> <ul> <li><a href="/cdn-cgi/l/email-protection#2c64796e6c594f5f4a02494859">Contact Us</a></li> <li><a href="https://www.ucsf.edu/accessibility-resources">Accessibility</a></li> <li><a href="https://www.ucsf.edu/website-privacy-policy">Privacy Policy</a></li> <li><a href="https://websites.ucsf.edu/website-terms-use">Terms of Use </a></li> <li><a href="https://websites.ucsf.edu/azlist">A-Z Website List</a></li> </ul> </nav> <div class="footer--copyright"> <p>© 2024 The Regents of the University of California</p> </div> </div> </div> </div> </div> </div> <script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script><script type="text/javascript"> /*<![CDATA[*/ (function() { var sz = document.createElement('script'); sz.type = 'text/javascript'; sz.async = true; sz.src = '//siteimproveanalytics.com/js/siteanalyze_8343.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(sz, s); })(); /*]]>*/ </script> </body> </html>