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Electronic Records and Signatures - Guidelines

Guidelines related to electronic records and signatures:

EU Directive 91/356 (EU GMP Guideline) – This directive specifies legal requirements for good manufacturing practice (GMP) in the European Union (EU). It requires that data be available at the proper time, provided in a readable form, and protected against damage or loss.

ICH Q7A Guideline – International Conference on Harmonization (ICH) Q7A provides guidelines for active pharmaceutical ingredients in the EU, the United States, and Japan.

PIC/S – The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Cooperation Scheme (PIC/S) provide guidance on pharmaceutical inspections.

Title 21 CFR Part 11 – This U.S. FDA regulation establishes requirements for electronic records systems, regulating the use of computer systems, audit trails, lot and serial traceability, change control, archiving, e-signatures, and security.