ICH E6(R3) Annex 1 Site Kit 01, Quality System Foundations — 14 records across 3 procedures

E6(R3) Site Kit 01 — Quality System Foundations

$369.00
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ICH E6(R3) Annex 1 Site Kit 01, Quality System Foundations — 14 records across 3 procedures

E6(R3) Site Kit 01 — Quality System Foundations

$369.00

Buying from the EU or UK? Register your business first — VAT-registered businesses buy without VAT under the reverse charge. We are not able to sell to private individuals in the EU or UK.

The quality system the other ten kits get issued under: document control, risk, and who is qualified to do what.

3 procedures, 14 records. Answers 8 site-facing E6(R3) expectations, 3 of them new in R3.

  • Document control and management of site SOPs
  • Quality by design, risk management and critical-to-quality factors
  • Training and qualification records for site personnel

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.

Pairs well with