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Computerized System Validation: 3 Pages Inspectors Read
An inspector does not read a validation package from page one. He opens three places and works from there: the requirements traceability matrix, the raw execution records for high-risk functions such as permissions, audit trail, electronic signature and backup and restore, and the deviation list together with its conclusion statement. If those three hold up, the remaining pages rarely matter at all. The fifteen minutes that decide an inspection A quality assurance team once wheeled in a bound LIMS validation package for an inspection. URS, FS, DS, installation qualification, operational qualification, performance qualification, a traceability matrix, training records. More than 400 pages, every line marked Pass. The inspector never started…
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Drug Development Documentation: Protocols, Raw Records, and Study Reports That Pass Inspection
Most development findings aren’t about bad science. They’re about paperwork. When an inspector writes something up, the cause is usually mundane. A protocol element nobody filled in. An acceptance criterion so loose it can’t fail. A raw record written three days after the fact. A report whose numbers quietly disagree with the notebook underneath it. This piece walks the three documents that actually carry a development program: the protocol, the raw records, and the study report. It also covers where small molecules and biologics need to split off, because one shared template for both guarantees gaps somewhere. What are the key documents in drug development? Three of them: the study…
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FDA CMC Requirements: What Reviewers Actually Check
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