I’m interested in how other organizations handle supplier change tracking in Qualio for compliance purposes. We’re currently debating whether to rely primarily on document versioning or comprehensive audit trails for our supplier qualification files.
Our regulatory requirements (ISO 13485 and FDA 21 CFR Part 820) mandate complete traceability of supplier changes, especially for critical suppliers. We track supplier certificates, audit reports, quality agreements, and approved product lists.
Currently we’re using document versioning for major changes (new certificates, audit results) but the audit trail for minor updates (contact changes, facility addresses). However, our recent internal audit questioned whether this hybrid approach provides sufficient traceability for regulatory inspections.
What’s your organization’s philosophy on this? Do you version everything or rely on audit trails? How do you balance compliance requirements with practical usability?
One thing to consider is how your change control process integrates with supplier management. We require a formal change control record for any supplier change that could impact product quality - new manufacturing site, material specification changes, process modifications. These changes trigger both a new document version AND a linked change control record. The change control provides the impact assessment and approval workflow, while the version provides the snapshot. For administrative changes, audit trail only.
Don’t forget about the reporting implications. When you’re preparing for regulatory submissions or responding to audit findings, version-controlled documents are much easier to package and reference. We learned this during a 510(k) submission where we needed to demonstrate supplier controls. Having versioned supplier files with clear approval dates made the documentation package straightforward. Audit trails required extensive filtering and explanation. Our policy now: version anything that might be referenced in regulatory submissions.
That’s an interesting point about audit trails being more robust, James. My concern is that audit trail entries can become overwhelming when you have 200+ suppliers with frequent updates. How do you manage audit trail review during internal audits or supplier reviews? Do you have automated reporting or do you manually review trail entries?