Oct 07 2026
16:00 BST - 17:00 BST | 01:00 AEST - 02:00 AEST | 11:00 EDT - 12:00 EDT
If an auditor asked for your complete review history today, could you produce it immediately, or would it take days? Most quality management systems were built to govern approved documents, not the review that happens before approval. This session unpacks why that gap exists and what a defensible, audit-ready review process actually requires.
Every regulated organization trusts its QMS to control approved documents: version history, distribution, sign-off, a defensible record of change. But the most important decisions happen earlier, while a document is still being drafted, challenged and revised and that stage rarely gets the same rigor.
This session examines why that gap forms, whether review happens through email and shared drives, or through a dedicated review tool operating alongside the QMS rather than inside it and why both paths tend to produce the same result: a review trail that's difficult to reconstruct when an auditor asks for it.
We'll walk through what a truly audit-ready review process needs to show and close with the distinction that actually matters: not a better connection between two systems, but review that lives natively inside the QMS itself.
This session is for quality, regulatory affairs and compliance professionals in regulated industries who want a clearer picture of where review breaks down today and how leading organizations are closing that gap.
Why a QMS was built to govern approved records, not the review process that leads up to them.
The two most common ways document review breaks down today, and why both create the same audit risk.
What auditors actually expect to see in a defensible review record and why that standard applies directly under GxP, 21 CFR Part 11 and ISO 13485.
The difference between a connected review process and one that's truly embedded inside your QMS, and how to benchmark your own process against it.
Majid is a senior product leader with over 20 years of experience delivering SaaS and collaboration platforms across enterprise and startup environments. He leads the Please Review product with a focus on turning customer challenges into measurable outcomes.
