With the never ending shift towards quality within the manufacturing of pharmaceutical products it is worth looking at the current requirement of GMP and also 21 CFR Part 11 in the context of GAMP 5 requirements. How a company creates, maintains, retrieves, corrects and controls data can affect product quality. As far as electronic records are controlled, the FDA's main concern has remained the same since the introduction of 21 CFR Part 11 and that is "to safeguard record integrity in order to ensure product quality". Therefore "record integrity and data integrity" is a focus by the FDA during regulatory audits.
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