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. – Record or capture all generated raw data directly, promptly, and legibly. – Use traceable data sheets or sequentially numbered notebooks. – Date and sign or initial dataentries on the day of entry. GMP requires that all critical steps of manufacture are reliable or validated.
We will present the rationale behind the qualification decision and reference that with the GAMP (Good Automated Manufacturing Practice) categories in support of the decision you will make. The dataentry and retrieval process, user access and security, electronic signature, audit trail, system integration, performance, printing, etc.
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