Officially there is no requirements as per the FDA and other regulatory bodies for “good documentation practices”, however, it is a “current” .. Read more industry practice and if often reviewed and cited by auditors during audits. All legal and controlled documents are subject to the retention of information which should include the sign and dating of such data by the person responsible. Good documentation practices are expected to assure that all recorded data is accurate, legible and traceable. We all know that the FDA strongly believes “if it wasn’t documented, it didn’t happen”. FDA also wants to see how you document results. It’s also been observed that the lack of good GDP is consistently cited in FDA 483 observations. The training departments need to make GDP an integral part of every employee training.
Kenneth ChristieQuality Assurance and Validation Management
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