I'll second Loganathan's advice, which aligns with that of my SharePoint validation SME and the approach we're taking in my recent and current ongoing experience performing SharePoint software intended use and SharePoint Part 11 qualification/validation.
Note also that SharePoint Part 11 qualification/validation compliance work can leverage some important Microsoft Part 11 testing already acknowledged and accepted by FDA, and thus available for leveraging by industry. But further to the point made above, while one does not need to start with a blank slate when approaching SharePoint Part 11 work, it, on the other hand, remains necessary that SharePoint requires a certain amount of Part 11 qualification/validation work for organic bridging regarding a user's particular use of SharePoint. Yet this opens the door for the SharePoint qualification/validation burden to be less rigorous than other alternatives.
Regarding guidance, I know of no specific Part 11 guidance regarding compliance of cloud-based document storage other than a careful interpretation and adaptation of FDA's 2003 guidance on Part 11 enforcement discretion.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
ComplianceAcuity, Inc.
Ridgway, CO
United States
www.complianceacuity.com© Copyright 2020 by ComplianceAcuity, Inc. All rights reserved.
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Original Message:
Sent: 30-Jan-2021 13:04
From: Noemi Olivo
Subject: Microsoft SharePoint for internal document management system
Thank you Loganathan, I will follow your advice. One more question if you don't mind, are guidelines specific to validation procedures for Part 11 compliance of cloud-based document storage? I truly appreciate your help.
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Noemi Olivo
Woodcliff Lake NJ
United States
Original Message:
Sent: 27-Jan-2021 19:48
From: Loganathan Kumarasamy, MS RAC
Subject: Microsoft SharePoint for internal document management system
As long as you are planning to qualify the configuration and confirm that it meets the Part 11 requirements, you are good to go! We have used Microsoft SharePoint built configurations as QMS and have validated it along with Part 11 Assessment to confirm that it is compliant. Remember, technical controls alone are not sufficient to claim Part 11 compliance, you will need to have policies / procedures to support your application.
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Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
Original Message:
Sent: 27-Jan-2021 11:51
From: Anonymous Member
Subject: Microsoft SharePoint for internal document management system
This message was posted by a user wishing to remain anonymous
My company is considering using Microsoft SharePoint via Office 365 for it's internal document management system. It's Office 365 is ISO 27001 certified and has successfully undergone independent third-party audits for quality management and information security. Is this enough to satisfy the FDA 21 CFR Part 11 requirements. I have read that there are no GxP or 21 CFR Part 11 for certification for cloud service providers.
Thank you!