Independently assessed. Customer-controlled updates.
V5 Ultimate is being assessed against 21 CFR Part 11, EU GMP Annex 11, GMP and GAMP 5 by Dr Bob McDowall — the same independent assessor who has reviewed V5 Classic for years. IQ/OQ/PQ for private-cloud tenants is executed with system assist. Every released version stays available in Git so updates are yours to schedule, not ours to push.
Assessed by Dr Bob McDowall — the same reviewer who has covered V5 for years.
Dr R. D. (Bob) McDowall is an internationally recognised independent consultant on computerised system validation, data integrity and Part 11 / Annex 11 compliance, with decades of published work in the regulated laboratory and manufacturing space. He has independently assessed V5 Classic against 21 CFR Part 11 — see the V5 Classic assessment on sgsystemsglobal.com.
The V5 Ultimate 5.10 assessment is currently underway, scope agreed, targeted for completion mid-August 2026. It covers 21 CFR Part 11 (electronic records & signatures), EU GMP Annex 11 (computerised systems), GMP fundamentals relevant to computerised system use, and a GAMP 5 second-edition lifecycle review.
Interim status (2026): scope agreed; gap analysis available under NDA on request.
- 21 CFR Part 11 — controls for electronic records & signatures
- EU GMP Annex 11 — computerised systems (risk, validation, data)
- GMP fundamentals relevant to CSV
- GAMP 5 (2nd ed.) lifecycle & category assessment
- Audit trail integrity & ALCOA+ traceability
- Access control, roles, and segregation of duties
System-assisted qualification for private-cloud tenants.
Installation Qualification (IQ)
System-assisted IQ script confirms bundle signature, dependency versions, database schema, service accounts, network endpoints and TLS. Machine-generated evidence lands in a signed IQ report the Customer QA countersigns.
Operational Qualification (OQ)
A configurable OQ template exercises core workflows — user management, e-signature, audit trail, backup/restore, batch execution and reporting — against your tenant. Test scripts, expected results and screenshots auto-assemble into the OQ pack.
Performance Qualification (PQ)
PQ is Customer-owned and Customer-executed against the intended business process on your master data. V5 provides the PQ plan template and evidence capture; Customer QA approves and signs.
Customer-instigated updates. Every version preserved.
How major versions work
- Private-cloud tenants deploy the assessed release (currently 5.9; 5.10 once the McDowall assessment completes).
- Major versions from 5.11 onwards are made available for Customer-instigated update as and when released — usually on an annual cadence.
- Each new release ships with a refreshed assessment pack and a version-to-version change summary, so QA can scope re-validation before committing.
- All prior versions are retained in Git. A tenant can remain on an assessed version indefinitely, provided it stays within its supported window for security patches.
Why we don't push updates
In regulated manufacturing, an unplanned change is a validation event. We treat staying on a qualified release as a legitimate operational choice — not a compliance risk to be nagged about. Security-relevant fixes are backported to supported majors so a tenant is never forced to take a functional change for a security reason.
When you decide to move, the change summary, updated assessment pack, refreshed IQ/OQ scripts and a delta test plan are delivered together, so re-qualification is scoped — not open-ended.
What lands in your validation binder.
Independent assessment letter
Dr McDowall's signed assessment of V5 Ultimate against Part 11 / Annex 11 / GMP / GAMP 5.
Traceability matrix
URS → FS → DS → test evidence, mapped to Part 11 §11.10 and Annex 11 clauses.
IQ / OQ / PQ packs
System-assisted IQ & OQ evidence per tenant, with the Customer-approved PQ plan and results.
Version change summary
Per-release delta with impact assessment against validated functions.
GAMP 5 category & lifecycle
Category rationale and lifecycle documentation aligned to GAMP 5 second edition.
Support & patch policy
Written statement of supported majors, security-patch policy and end-of-support notice periods.
Want the interim assessment status or an early look at the 5.10 pack?
We share a gap analysis under NDA ahead of the mid-August 2026 assessment completion — enough for QA/RA to shape their validation strategy.