AABB’s comment on the FDA’s Docket No. 00D-1538 Draft Guidance for Industry; Electronic Records; Electronic Signatures, Validation; Availability as it relates to Validation Plans.
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Overview
I’ve recently reviewed a post from the American Association of Blood Banks (AABB) regarding the FDA’s Draft Guidance for Industry; Electronic Records, Validation; Availability (FDA Document No. 00D-1538). The FDA guidance document and AABB response were both dated back in 2001. However, I feel part of the response from AABB was important to note since I believe this will not change in any future guidance and in my opinion would be considered ‘best practices’ for validation. I’m speaking about the need for the creation of Validation Plans prior to starting the validation activity for a computer system and the need for management’s understanding of the computer system and operational process before review and approval of a Validation Plan.
FDA Docket No. 00D-1538: Section 5.2.1 – Validation Plan
This is the 2001 Draft Guidance which addresses Computer System Validation (CSV) activities among other topics. The section I will focus on is Section 5.2.1, Validation Plan, which gives very general guidelines for the creation of a validation plan. Among the items to be considered are scope, approach, tasks, responsibilities, and review/approval by management.
AABB’s response (December 2001)
I discovered this article while performing a google search for the draft guidance document. Here is the link to AABB response. AABB’s response to Section 5.2.1 calls for tighter controls over the Validation Plan requirements specifically calling for facilities to create the validation plan prior to execution for the purpose of catching the areas of weakness and critical function prior to actual commencement of testing activities. Furthermore, they go on to state that management responsible for approval and review of the Validation Plan be knowledgeable of the systems being validated and related operational process.
Again, it is important to state that this was feedback on a draft guidance document.
Validation Plan Overview
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Create Validation Plans Prior to Validation – Don’t let the cart pull the horse. Creation of a Validation plan before the actual validation activities shows that the process is not an afterthought but actually part of a well planned and executed validation. This process will help drive the importance of critical functions and identify areas that need attention. You wouldn’t create your standards for QC release after you performed the release testing, why would you create the Validation Plan after validation?
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Review and Approval by Knowledgeable Management – Management involved in the review and approval of all elements of the validation process should understand both the computer system and related operational process. At a minimum, all review personnel should be at the basic system user level. For the operation process, management should be very familiar and have a solid understanding.
I welcome any and all feedback on my posts.
If you are interested in how my expertise can contribute to your validation project or company, please contact me at greggsalomon @ yahoo dot com.
Quality meets Validation 