airclinical

Do our existing SOPs need updating for E6(R3)?

Usually yes, but rarely a rewrite. Most pre-R3 procedures are structurally sound and need reworking around risk-based quality management, sponsor oversight of delegated activities, and data governance. A gap assessment against E6(R3) will tell you which procedures need revision and which can stand as they are.

ICH-GCP & E6(R3)Getting started

Need help with sops?

Tell us where you are — we'll handle the rest.

SOPs →