Life Sciences

Are Test User Accounts Subject To 21 CFR Part 11?

test-user-accounts-21-cfr-part-11

 

On Thursday, April 23, 2015, we delivered a webinar on 21 CFR Part 11, based on a recent blog series. During the Q&A session at the end, someone asked the following question:

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Regarding user accounts: During the User Acceptance Testing (UAT) of a system, are these accounts regulated the same way or can ‘generic’ user accounts be used? 

Our interpretation of the regulations is that they do not govern user accounts in non-production environments, such as development (DEV) or even validation (VAL). Given that, during the initial validation or as part of a change control, if the UAT is performed in a non-production environment, ‘test’ user accounts can be used that do not adhere to the regulations about being unique for each individual, having a unique combination of user ID and password, etc.

As a best practice, dummy or test user accounts should not be created in production environments. However, in cases where production is the only environment that exists, test user accounts can be created, but should adhere to 21 CFR Part 11 and then disabled after testing.

If you have any comments or follow-up questions on this topic, we’d love to hear from you. To see what other questions were asked during the webinar, click here.

About the Author

As the Head of Validation in Perficient’s life sciences practice, Sally Miranker is responsible for overseeing the Computer System Validation (CSV) methodology, System Development Life Cycle (SDLC), and all project-related validation activities. She has over 20 years of experience in the industry with almost a decade focused on implementing computer systems within regulated environments. Her knowledge and experience contribute to her ability to ensure that Perficient’s internal and client systems are implemented effectively, in compliance with internal procedures and external regulations, and following best industry practices. Prior to joining the company in 2009 via the acquisition of BioPharm Systems, Sally held a Siebel Systems Analyst position at Amylin Pharmaceuticals.

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