V5 Ultimate 5.10: independently assessed against 21 CFR Part 11.
Dr R.D. (Bob) McDowall assessed V5 Ultimate version 5.10 against FDA 21 CFR Part 11 and the pharma GMP predicate rule, 21 CFR 211, between July and September 2026. His report concludes that V5's technical controls for Part 11 are compliant.
Technical controls assessed as compliant
Unique user identity and password tied to a role (Operator, Supervisor, QA Manager, Reviewer, Approver, Auditor, IT Administrator and more).
The system confirms the connected scale or balance is the right one and working correctly before dispensing.
Workflow steps run in the defined sequence and cannot be overridden.
Changes to GMP records are detected and written to the audit trail.
Creation and modification of GMP records is tracked, with a configurable workflow to record the supervisor's audit-trail review electronically.
A user can be blocked from executing a recipe or reviewing a batch record until they are trained.
Signatures are applied electronically and linked to their records.
Regulated records are never permanently deleted in normal manufacturing; a permitted delete hides the record but keeps it and its history.
The report reviews V5's AI against draft EU GMP Annex 22 and GAMP guidance. AI output has to be checked by a trained user, and AI is never used to make a decision. See V5 AI.
Part 11 compliance needs V5's technical controls plus your own procedures and admin controls. The report sets out what SG Systems provides and what the customer is responsible for.
The assessment covers manufacturing automation, both on-premises (air-gap capable) and private-cloud single-tenant setups. V5's QMS and QC modules were outside its scope.