Process Performance Qualification - Pharmaceutical …
The pharmaceutical industry is one of the most intensely regulated industries. One regulatory requirement is to validate the process to ensure that the process consistently deliver quality products. Since 2011 the FDA recommends a lifecycle approach to process validation, including three stages: Stage 1-Process Design, Stage 2-
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FDA Title 21 CFR Part 11 - Electronic Guidance
www.pharmaceutical-networking.come-audit trail according to specifications. Record the actions manually ... Check the system design and verify that there is a clear link between the electronic signature and the data file. For example, ... electronic form suitable for inspection, review, and copying by the agency. Persons should contact the agency if there
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