FDA responses to questions regarding the practice of performing audits in clinical investigations.
Are sponsors required to conduct a 21 Part 11 Assessment and/or on site audit when a laboratory is CLIA certified?
CLIA certification does not imply that Part 11 requirements have been met, and there are no FDA regulations that specifically address assessments and audits of CLIA-certified laboratories. Part 11 address the validation of systems, not the validity of a laboratory measurement. Sponsors can decide on their own vendor and should use tools to establish that the computer system is validated (from 2015). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
What is the expectation for 21 Part 11 audits for vendors as almost every vendor today is using an electronic system? Should this only be considered when the data is in support of a study endpoint?
There are no FDA regulations that specifically address vendor audits. It is up to the sponsor to develop a justified, risk-based plan to meet Part 11 regulation requirements (from 2015).Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Does the FDA provide a preliminary audit service to inspect an electronic system used in a clinical investigation to ensure compliance with part 11 controls?
No, but the electronic systems would be evaluated during a regulatory inspection (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
Should sponsors and other regulated entities perform audits of the vendor’s electronic systems and products?
It is not required, but it is recommended to base their decision to perform vendor audits on a risk-based approach. Additionally, third parties can conduct audits (from 2017). Documentation in the Florence Library of FDA eRegulatory and eSource Guidance
From Florence’s Complete Library of FDA eRegulatory and eSource Guidance
The summaries presented in our library are for informational purposes only, they are not for implementation in operations. Please consult official FDA guidance documents for operational use.
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