Validation documentation storage

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Dear experts, Could you please share your experience regarding validation documents retention period. If the company develops software for regulated...

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Posted by Anna Petrovskaya (Discussions: 1, Comments: 1)
Replied on August 20, 2018 12:00 am
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The regulated company is responsible to manage regulatory documentation. However, if you provide services to them that directly impact their regulated documentation, then you may have to keep this material. For example - if you're a SaaS shop, you are probably housing customer installation documentation, or documentation related to the software product you released (customer may believe they are leveraging your testing to justify their internal validation efforts), procedures related to your development process, your vendor qualification records for a hosting company, or training records for personnel managing their SaaS environments. Your quality agreements should outline clearly what the client wants you to retain and for how long.

The FDA had a draft guidance that talke about the expectations for handling cloud vendors. Don't know what happened with it but it had some good info: https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm563785.pd
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Posted by Akash Arya (Discussions: 1, Comments: 13)
Replied on August 19, 2018 8:00 pm
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Hi Anna,

That's mainly on the document management sip of the pharma client. If the software developer is following the client methodology to validate the software then, the maintenance of those documents shall be in line with that SOP. However, if there is a contract to between the software vendor and client that the Pharma company shall archive the documents, then software vendor can set up a procedural control on sharing the documents to the client for the archival. For e.g. if the software vendor is maintaing the software for the client, vendor can get the procedural approvals from client on how the vendor shall implement the changes and how the documents shall be shared for archival either on the Monthly basis or on an yearly basis. And also please make sure if the software vendor is archiving the documents, then they are having the Fire proof cabinets which is requirement from the Regulatory Authorities.

Hope this helps you....
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Posted by Srinath Y G (Discussions: 0, Comments: 7)
Replied on August 21, 2018 8:00 pm
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I think the development company supposed to give copies of the required documents to the purchasing company along with license. The purchasing company have to maintain them for as long as required. The regs clearly pin this responsibility on the purchaser company.
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Posted by Yogesh C. Jagtap, PMP (Discussions: 0, Comments: 9)
Replied on August 21, 2018 8:00 pm
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It is responsibility of client
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Posted by Riyaz Mohd (Discussions: 0, Comments: 1)
Replied on August 22, 2018 8:00 pm
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Agree with all the comments above. If software is SaaS, then vendor will need to provide the services of the updated document as well. So, everything will lies on the SLA signed between client and vendor.
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Posted by YongHut Lau (Discussions: 0, Comments: 2)
Replied on August 22, 2018 8:00 pm
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It is solely depends on the arrangements made between vendor and the client, if it’s SaaS then as some of them said, as a client you may need to utilise their qualification documentation and vendor should be able to retrieve the documentation around the qualification at any point of time for you. Unless you have done any performance qualification.

Also, We have moved out of the paper copies of the validation documentation and stored soft copies on the server. No longer we maintain the hard copies of validation documents. Regulators are happy with that so far..
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Posted by Raghu Chikkamuniyappa , ITIL® v3,EU GDPR Certified (Discussions: 0, Comments: 3)
Replied on August 22, 2018 8:00 pm
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Also keep in mind the method of storage. Given the volume of paper being generated, many companies are trying to go paperless. They may only keep 5 years worth of paper, but the documents are also scanned and the scans are kept indefinitely, but CD or even DVDs don't last forever. You can't even buy a computer with a floppy drive anymore.
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Posted by Greg Ventura (Discussions: 0, Comments: 1)
Replied on August 22, 2018 8:00 pm
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