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MDR Retention and Compliance | Arkivum

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mb-4">Migration Service</span><p class="text-base font-light text-grey-v-light">End-to-end data migration service with minimal customer input</p> </a></div></div></div></div></div></li><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-40"> <a href="https://arkivum.com/case-studies/">Case Studies</a></li><li class="menu-item menu-item-type-post_type menu-item-object-page menu-item-has-children menu-item-182"> <a href="https://arkivum.com/resources/">Resources</a><div class="mega-menu absolute top-full left-0 right-0 bg-black text-white border-y-2 border-white/10 py-12"><div class="container"><div class="flex xl:gap-60px"><div class="min-w-[300px]"> <span class="text-2xl font-bold block mb-4">Valuable information and insights for our community</span> <a href="https://arkivum.com/resources/" class="y-btn inline-block">All Resources</a></div><div class="w-full"><ul class="list-none pl-0"><li class="menu-item menu-item-type-taxonomy menu-item-object-category 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rounded-5px w-full md:w-auto md:min-w-400px" action="https://arkivum.com"> <input type="text" class="search-input" placeholder="Enter search term" value="" name="s"/> <button id="search-submit" type="submit" class="bg-arrow-black bg-center bg-no-repeat size-10 border-l py-6 px-2.5 hover:bg-grey/10 transition duration-200 ease-linear"></button> <input type="hidden" class="home-url" value="https://arkivum.com"></form></div></div></div></div></header><div id="main-content-inner"><section class="bg-black"><div class="container" data-aos="fade-in"><div class="pt-60px md:pt-100px pb-60px "><div class="mb-3 breadcrumb-text-white" id="breadcrumb"><span><span><a href="https://arkivum.com/">Home</a></span> <i class="breadcrumb-separator bg-center bg-no-repeat bg-12px h-2.5 w-2.5 inline-block px-1.5"></i> <span><a href="https://arkivum.com/pharmaceutical-life-sciences/">Pharmaceutical &#038; Life Sciences</a></span> <i class="breadcrumb-separator bg-center bg-no-repeat bg-12px h-2.5 w-2.5 inline-block px-1.5"></i> <span class="breadcrumb_last" aria-current="page">Medical Devices</span></span></div><h1 class="text-hero-sm-mob md:text-hero-sm text-white mb-5 font-semibold">Mastering the complexities of retaining medical device trial records</h1></div></div><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-white"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover " fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#00D48C"/> </svg></div></section></section><section id="" class="scroll-mt-230px md:scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-white wp-elements-929567b20843bdbef00dc6b56f69f7e0"><div class="container text-left" data-aos="fade-in"><h2 class="mb-5 text-2xl md:text-4xl font-extrabold text-black">The challenge of MDR retention and Compliance</h2><div class="content-wrapper mb-5 text-black content-black" ><p>According to the medical device regulation (MDR 745), anyone conducting a medical device trial is legally obliged to comply. In the interest of patient health and safety, the MDR states that documents and records relating to medical devices must be retained for a minimum of 10 years, depending on how long the device is available on the market.</p><p>To add complexity, time frames also depend on the nature of the device. Throughout this period, it is important that all documents and records are accessible and legible to both staff and regulators.</p><h3>MDR Retention Risk Management</h3><p>By not complying with MDR, Medical device manufacturers risk:</p><ul><li>Regulatory fines</li><li>Product recalls</li><li>Reputational damage</li><li>Ability to bring new products to market</li></ul><p>Using a validated archiving and preservation solution simplifies documentation management for medical device manufacturers with varying retention requirements. This ensures all documentation is complete and readily available when needed, providing confidence and peace of mind.</p></div></div></section><section class="relative md:h-[120px] -mb-30px md:-mb-60px "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-white"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-black"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover -scale-y-100" fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#050505"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black wp-elements-1dc4772a25d002310f95cc4b0fe80a1b"><div class="container"><div class="grid lg:grid-cols-2 gap-10 xl:gap-20"><div class="relative lg:order-1" data-aos="fade-in"><div class="lg:absolute inset-0 rounded-5px overflow-hidden h-600px lg:h-full"> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABAAAAAMAAQMAAACAdIdOAAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAAHZJREFUeNrtwQEBAAAAgiD/r25IQAEAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAO8Ggw8AAeUA3VQAAAAASUVORK5CYII=" height="2400" width="3200" alt="Arkivum image" class="size-full object-cover lazyload" data-src="https://arkivum.com/app/uploads/2024/07/5-1024x768.png" data-srcset="https://arkivum.com/app/uploads/2024/07/5-1024x768.png 1024w, https://arkivum.com/app/uploads/2024/07/5-300x225.png 300w, https://arkivum.com/app/uploads/2024/07/5-768x576.png 768w, https://arkivum.com/app/uploads/2024/07/5-1536x1152.png 1536w, https://arkivum.com/app/uploads/2024/07/5-2048x1536.png 2048w" data-sizes="auto" data-eio-rwidth="1024" data-eio-rheight="768"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/5-1024x768.png" srcset="https://arkivum.com/app/uploads/2024/07/5-1024x768.png 1024w, https://arkivum.com/app/uploads/2024/07/5-300x225.png 300w, https://arkivum.com/app/uploads/2024/07/5-768x576.png 768w, https://arkivum.com/app/uploads/2024/07/5-1536x1152.png 1536w, https://arkivum.com/app/uploads/2024/07/5-2048x1536.png 2048w" sizes="(max-width: 1024px) 100vw, 1024px" height="2400" width="3200" alt="Arkivum image" class="size-full object-cover " data-eio="l"></noscript></div></div><div class="lg:order-2" data-aos="fade-in"><div class=" lg:py-60px"><h2 class="mb-5 text-2xl md:text-4xl font-extrabold text-white">Certainty with centralised data.</h2><div class="content-wrapper mb-5 text-white content-white" ><p>Transferring medical device documentation to systems or even file sharing platforms such as SharePoint introduces potential risks further down the line. Without appropriate digital preservation measures, there&#8217;s a looming threat of loss or corruption, leading to digital illegibility and accessibility over time.</p><p>Consolidating all medical device documents and records into a single GCP-compliant archiving and preservation solution offers several benefits:</p><ul><li>Active digital safeguarding and preservation to uphold data integrity in accordance with ALCOA+ principles.</li><li>Compliance with MDR and supporting alignment with ISO 14155:2020</li><li>Simplifies the management and accessibility of your entire portfolio of medical device-related GCP documentation</li><li>Management of audited user access</li><li>Cost-effective long-term solution that avoids vendor lock-in.</li></ul></div></div></div></div></div></section><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-black"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-black"></div><div class="relative stream-wrapper"> <svg class="w-full h-60px md:h-120px object-cover " fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-297.329 54.2271V122H640.654C660.466 122 679.821 115.934 696.063 104.627L724.061 85.1456C740.325 73.8392 759.658 67.7729 779.471 67.7729H1646.67V0H896.381C876.571 0 857.221 6.0663 840.971 17.3727L812.981 36.8544C796.711 48.1608 777.381 54.2271 757.568 54.2271H-297.329Z" fill="#00D48C"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black wp-elements-9f6c538dc69799a213b6294f2d87149a"><div class="container"><div class="lg:text-center mb-60px" data-aos="fade-in"><h2 class="mb-5 text-2xl md:text-4xl font-extrabold text-white">GCP-compliant archiving and preservation</h2><div class="content-wrapper text-white" ><p>Arkivum provides the only validated GCP digital archiving and preservation solution. We support our customers to adhere to long-term retention regulations such as MDR, by ensuring that records are available, accessible and legible for as long as they are needed. Our solution is aligned to the ALCOA+ principles both now and in the future.</p><p>Find out more about some of the key features of our solution below.</p></div></div><div class="grid lg:grid-cols-3 gap-10 lg:gap-60px"><div data-aos="fade-in"><div class="size-60px mb-5"> <img decoding="async" src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAABLAAAASwAQMAAADR7yGMAAAABlBMVEUAAAD///+l2Z/dAAAAAXRSTlMAQObYZgAAAAlwSFlzAAAOxAAADsQBlSsOGwAAAMZJREFUeNrtwTEBAAAAwqD1T20JT6AAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAAA4G/D7gABl3NkWgAAAABJRU5ErkJggg==" height="1200" width="1200" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Regulatory-1.png" data-srcset="https://arkivum.com/app/uploads/2024/07/Regulatory-1.png 1200w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-768x768.png 768w" data-sizes="auto" data-eio-rwidth="1200" data-eio-rheight="1200"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Regulatory-1.png" srcset="https://arkivum.com/app/uploads/2024/07/Regulatory-1.png 1200w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Regulatory-1-768x768.png 768w" sizes="(max-width: 1200px) 100vw, 1200px" height="1200" width="1200" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div><h4 class="text-xl mb-2.5 text-white">Regulatory Compliance Features</h4><div class="mb-0 content-wrapper text-white"><p>Managing documents and records for medical devices poses challenges due to the varying retention requirements, starting with a minimum of 10 years. Arkivum provides a suite of tools to help manufacturers align with regulation e.g. retention rules and legal holds.</p></div><div class="btn-set mt-5"> <a href="https://arkivum.com/regulatory/" class="y-btn btn-white" target=""> Find out more </a></div></div><div data-aos="fade-in"><div class="size-60px mb-5"> <img decoding="async" src="data:image/png;base64,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" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Preservation-1.png" data-srcset="https://arkivum.com/app/uploads/2024/07/Preservation-1.png 1600w, https://arkivum.com/app/uploads/2024/07/Preservation-1-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Preservation-1-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Preservation-1-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Preservation-1-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Preservation-1-1536x1536.png 1536w" data-sizes="auto" data-eio-rwidth="1600" data-eio-rheight="1600"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Preservation-1.png" srcset="https://arkivum.com/app/uploads/2024/07/Preservation-1.png 1600w, https://arkivum.com/app/uploads/2024/07/Preservation-1-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Preservation-1-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Preservation-1-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Preservation-1-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Preservation-1-1536x1536.png 1536w" sizes="(max-width: 1600px) 100vw, 1600px" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div><h4 class="text-xl mb-2.5 text-white">Data Preservation</h4><div class="mb-0 content-wrapper text-white"><p>In the face of rapid technological evolution, medical device manufacturers require assurances that their documents and records remain accessible and legible for over 10 years. To ensure you stay ahead, Arkivum&#8217;s digital preservation tools automatically retain copies in long-term formats, guaranteeing legibility for as long as necessary.</p></div><div class="btn-set mt-5"> <a href="https://arkivum.com/preservation/" class="y-btn btn-white" target=""> Find out more </a></div></div><div data-aos="fade-in"><div class="size-60px mb-5"> <img decoding="async" src="data:image/png;base64,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" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain lazyload" data-src="https://arkivum.com/app/uploads/2024/07/Migration-1.png" data-srcset="https://arkivum.com/app/uploads/2024/07/Migration-1.png 1600w, https://arkivum.com/app/uploads/2024/07/Migration-1-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Migration-1-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Migration-1-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Migration-1-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Migration-1-1536x1536.png 1536w" data-sizes="auto" data-eio-rwidth="1600" data-eio-rheight="1600"><noscript><img decoding="async" src="https://arkivum.com/app/uploads/2024/07/Migration-1.png" srcset="https://arkivum.com/app/uploads/2024/07/Migration-1.png 1600w, https://arkivum.com/app/uploads/2024/07/Migration-1-300x300.png 300w, https://arkivum.com/app/uploads/2024/07/Migration-1-1024x1024.png 1024w, https://arkivum.com/app/uploads/2024/07/Migration-1-150x150.png 150w, https://arkivum.com/app/uploads/2024/07/Migration-1-768x768.png 768w, https://arkivum.com/app/uploads/2024/07/Migration-1-1536x1536.png 1536w" sizes="(max-width: 1600px) 100vw, 1600px" height="1600" width="1600" alt="Arkivum image" class="size-full object-contain " data-eio="l"></noscript></div><h4 class="text-xl mb-2.5 text-white">Migration Service</h4><div class="mb-0 content-wrapper text-white"><p>Arkivum鈥檚 validated migration service takes the stress away from moving data. Our experienced migration team specialises in transferring large volumes of technical documentation from multiple sources. Customers maintain control and oversight with minimal effort on their part.</p></div><div class="btn-set mt-5"> <a href="https://arkivum.com/migration-service/" class="y-btn btn-white" target=""> Find out more </a></div></div></div></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px section-wrapper padding-top-regular padding-bottom-regular bg-black wp-elements-b8bd6c14735baae0b5f6a55fcd59e3a2"><div class="container"><div class="xl:flex gap-60px"><div class="lg:w-400px mb-5 xl:mb-0 flex-shrink-0"><h2 class="text-white text-2xl md:text-4xl font-extrabold">MDR Retention and Compliance FAQs</h2></div><div class="w-full" itemscope="" itemtype="https://schema.org/FAQPage"><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">What is a medical device?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>MDR 745 changed how the EU classifies medical devices and, perhaps most importantly, expanded the definition to include more than had previously fallen under the Medical Device Directive. For example, MDR now includes certain aesthetic devices that have the same or similar characteristics and risk profiles as other medical devices which were previously covered.</p><p>MDR also classes medical devices differently based on their risk profile, and also whether or not the clinical investigation is invasive or just observational. What is important to note, is that many devices are now covered within the regulation that hadn鈥檛 previously fallen under the MDD, so it鈥檚 important to take note of whether this applies to you and your organisation.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">Does Arkivum support organisations in complying with MDR 745?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>Yes, the Arkivum solution supports organisations to align to the retention requirements of MDR 745. MDR states that documentation relating to that medical device, must be retained for at least 10 years after the device was last placed on the market (15 years in the case of implantable devices).<br /> The Arkivum solution ensures that data is finable, accessible and legible for as long as required.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">Do you have any guidance on the retention requirements for MDR 745?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>Yes, Arkivum published a blog post on the topic <a href="https://arkivum.com/blog/the-data-retention-requirements-of-mdr-745/">here</a>.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">How does Arkivum support my alignment with ISO 14155:2020?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>While Arkivum is not certified in ISO 14155:2020, our solution supports organisations with good documentation practice, alignment with GCP principles and, ultimately, their efforts to adhere to this standard.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">Why can&#8217;t I store my medical device documentation in SharePoint (or another file-sharing platform)?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>File-sharing platforms such as SharePoint are not designed to archive and preserve data for decades or longer. They do not have digital safeguarding and preservation capability to ensure that data remains accessible and legible for the entire retention period.</p><p>Arkivum highly recommends that any organisations responsible for retaining medical device documentation migrate these records into a dedicated long-term archive or repository.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">Are wearables included within the scope of MDR?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>The answer depends on the type and use of the wearable and the data that it is generating (and where it is going). It&#8217;s a complex field, and if you have data retention requirements relating to wearable devices, please contact us<a href="https://arkivum.com/contact-us/"> here</a>.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">Where is my data stored?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>The Arkivum solution is hosted on Amazon Web Services (AWS). We typically store customers&#8217; data in a minimum of two separate geographic locations, aligned with a customer&#8217;s data sovereignty requirements. An optional third escrow copy can be stored with Microsoft Azure if required.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">How do I access and manage the Arkivum solution?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>The Arkivum solution is managed through an online browser-based dashboard. It supports the majority of modern browsers such as Google Chrome and Microsoft Edge.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">Can you set retention policies for records and files?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>Yes, it is possible to set retention policies in place within the systems. It is also possible to place legal holds on these periods if required.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">How do I know if my data has become corrupted?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>Whenever a data integrity check is conducted (called a fixity check), the system uses a checksum to compare each to how the original looked when it entered the archive. The results of these checks (including any errors) are reported within the fixity report within the system.</p></div></div></div><div class="border-b border-white/20" itemscope="" itemprop="mainEntity" itemtype="https://schema.org/Question"><h5 itemprop="name" class="question hover:cursor-pointer mb-0 py-15px pr-10 text-lg md:text-xl text-white icon-after after:rotate-45 after:border after:border-green after:rounded-full after:p-15px after:bg-arrow-white">How long does it take for customers to be onboarded onto the solution?</h5><div class="hidden answer" itemscope="" itemprop="acceptedAnswer" itemtype="https://schema.org/Answer"><div class="content-wrapper content-white text-white pb-15px" itemprop="text"><p>Arkivum can work within customer timelines to onboard as quickly as they need. There are several steps required to set up a new system and train staff on its use, but we are confident that we can meet all customer timelines for onboarding.</p></div></div></div></div></div></div></section><section class="relative md:h-[120px] "><div class="absolute top-0 bottom-1/2 inset-x-0 bg-black"></div><div class="absolute top-1/2 bottom-0 inset-x-0 below-colour bg-white"></div><div class="relative stream-wrapper"> <svg class=" w-full h-[60px] md:h-[120px] object-cover -scale-y-100" fill="none" xmlns="http://www.w3.org/2000/svg" preserveAspectRatio="none" viewBox="0 0 1512 120"> <path d="M-66 54.2271V122H871.983C891.795 122 911.15 115.934 927.392 104.627L955.39 85.1456C971.654 73.8392 990.987 67.7729 1010.8 67.7729H1878V0H1127.71C1107.9 0 1088.55 6.0663 1072.3 17.3727L1044.31 36.8544C1028.04 48.1608 1008.71 54.2271 988.897 54.2271H-66Z" fill="white"/> </svg></div></section><section id="" class="scroll-mt-230px md:scroll-mt-130px overflow-hidden 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29.7H523V29.8Z" fill="#00D48C"/> </svg></div></div><div class="absolute left-5 bottom-5"> <span class="date text-white text-subtitle-sm">02 May 2024</span></div> </a></div><h3 class="text-black text-lg md:text-xl"> <a href="https://arkivum.com/blog/why-you-need-a-gxparchivist-in-your-organisation/" class="text-black">Why You Need a GxP Archivist in Your Organisation</a></h3></div><div> <a href="https://arkivum.com/blog/why-you-need-a-gxparchivist-in-your-organisation/" class="y-btn text-btn btn-text-black" target=""> Read more </a></div></article></div></div></div><div class="items-center gap-15px flex lg:hidden mt-10 text-black"><div class="resource-button-prev"></div><div class="resource-pagination-mobile text-black text-subtitle font-bold"></div><div class="resource-button-next"></div></div><div class="hidden lg:block absolute left-0 inset-y-0 bg-white w-300px z-10 before:absolute before:-left-[500%] before:right-0 before:inset-y-0 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