Independently assessed. Customer-controlled updates.
V5 Ultimate 5.10 has been independently assessed against 21 CFR Part 11 and 21 CFR 211 by Dr Bob McDowall — the same independent assessor who has reviewed V5 Classic for years. Enterprise adds system-assisted IQ/OQ and validation support; your team performs and approves PQ and intended-use validation. Every released version stays available in Git, and Private Cloud customers schedule feature updates within an agreed validation window.
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 published by S.G. Systems.
Classic and Ultimate are separate products. V5 Classic (Version 5.9) is On-Premises only; V5 Ultimate (Version 5.10) is available as Cloud, Private Cloud or On-Premises. A Classic assessment or licence does not carry over to Ultimate: moving requires a separate written order, and any migration services are scoped and agreed in writing first, with no automatic transfer of functionality or data (Commercial Terms §4.8).
The V5 Ultimate 5.10 assessment was completed and approved on 25 September 2026. It covers 21 CFR Part 11 (electronic records & signatures) and the pharma GMP predicate rule, 21 CFR 211, for manufacturing automation, and concludes that V5's Part 11 technical controls are compliant.
- 21 CFR Part 11 — controls for electronic records & signatures
- 21 CFR 211 — the pharma GMP predicate rule
- GAMP software category & AI use (draft EU GMP Annex 22)
- Audit trail integrity & ALCOA+ traceability
- Access control, roles, and segregation of duties
Enterprise IQ/OQ support; PQ stays customer-owned.
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 records the evidence in the system; Customer QA approves and signs.
Customer-instigated updates. Every version preserved.
How major versions work
- Private-cloud tenants deploy the assessed release (currently 5.10). The assessment supports, but does not replace, your own validation of your instance.
- 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 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 to walk through the assessment with our team?
We can talk your QA/RA team through the assessment and the 5.10 validation pack so they can shape their validation strategy.