E6(R3) Sponsor Kit 01 — Quality System Foundations
E6(R3) Sponsor Kit 01 — Quality System Foundations
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The procedures everything else hangs off: document control, risk, and who is qualified to do what.
3 procedures, 12 records. E6(R3) wants a quality system that is proportionate and risk-based (3.10), critical-to-quality factors identified rather than assumed (3.1.2), and appropriately qualified people for the work they are given (3.4).
- Procedure register, drafting and approval checklist, periodic review
- Trial risk register and critical-to-quality worksheet
- Qualification map, training records, medical cover arrangement
Do this kit first. Every other kit gets issued under its document control procedure, so approving them in the wrong order means re-issuing them afterwards.
Word and Excel, editable, no macros. Individual Licence. These are templates, not an approved quality system.