Annex 11 to EU GMP - Computerised Systems Clause 5: Data

What else in your programme already covers this

This control maps to 14 controls across 6 other frameworks. If you already hold one of them, the evidence you collected for it is the starting point here rather than new work.

Every mapping shown was judged rather than inferred from wording similarity, and the ones that failed review are published too. See the coverage reports and what was rejected.

Other controls in Operational Phase - Data Management

• Clause 6 Accuracy checks
• Clause 7 Data storage
• Clause 8 Printouts
• Clause 9 Audit trails