This presentation will review the regulations, citations, and typical procedures found in laboratory operations and then propose a way to build better documentation.1.What laboratory documentation is required for compliance,2.What are typical citations as it relates to laboratory documentation,3.With forethought and design, good procedures are possible,4.Good documentation and record integrity ensure good compliance
The goal of laboratory documentation should be to ensure compliance. However, failures in documentation and procedures represent more than half of the top citations by FDA. FDA is telling us we just don’t get it. As such we must look at what does proper documentation look like.
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