Each guide answers one question an analyst, operator or QA reviewer actually asks, cites the regulation, and shows the weak record next to the defensible one. Read them in module order or jump to the one you need today.
A plain-language definition of data integrity under EU GMP Chapter 4, Annex 11 and the PIC/S and EMA guidance, each ALCOA+ attribute with the failure that breaks it, and why inspectors open with it.
Read the guideThe rules for handwritten GMP records under EU GMP 4.7 to 4.9 and 4.20: making the entry, single-line corrections, late entries, blank fields, and what a second-person check is for.
Read the guideElectronic records in plain language: unique user identities, roles and privileges, what an audit trail must capture, why it must not be switchable, and how Annex 11 section 14 and the eIDAS Regulation govern electronic signatures.
Read the guideA risk-based audit trail review that finds reprocessing, aborted runs and deletions, documents what was reviewed, and fits into batch release, plus how to control a hybrid system where a signed printout sits beside an electronic original.
Read the guideFollowing a GMP record from creation to destruction: the retention periods in EU GMP 4.11 to 4.12 and Annex 11 section 17, backup versus archive, keeping electronic records readable, and when a spreadsheet becomes a computerised system under Annex 11.
Read the guideWhy data integrity is a management responsibility under PIC/S PI 041-1 and EU GMP Chapter 1, the signals inspectors read as culture, how to assess your own data risk, and what a remediation plan regulators accept looks like.
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