GxP software you can validate in weeks, not the fiscal year after next.
V5 Ultimate is a GxP-validated platform covering GMP manufacturing, GLP lab, GCP clinical supply, and GDP cold-chain workflows in a single Part 11 / Annex 11 audit trail. GAMP 5 Second Edition Category 4, CSA-aligned test evidence, IQ/OQ/PQ delivered at onboarding — not billed as a 6-month project.
You're shopping GxP software because your current tools don't survive an inspection.
Spreadsheets and shared drives can't demonstrate ALCOA+
Legacy LIMS or QMS shipped without validation evidence
Your CSV project has run 9 months and hasn't started PQ
Cloud vendors won't sign a validated SaaS agreement
Every 'GxP' vendor demo skips the audit-trail export
Inspectors flagged contemporaneity, attributability, or originality
One validated platform for every G-in-GxP your site touches.
GMP manufacturing
Electronic batch records, in-process controls, deviation workflow, calibration and equipment status — all Part 11 signed.
GLP laboratory
Sample login, instrument interfaces, method execution, OOS/OOT triggers, chain-of-custody, and stability protocols.
GCP clinical supply
Blinded/unblinded IMP workflows, kit reconciliation, temperature excursions, sponsor visibility.
GDP cold chain
Temperature-controlled storage and distribution, excursion investigation, driver / vehicle qualification, MHRA-aligned.
ALCOA+ audit trail
Attributable, Legible, Contemporaneous, Original, Accurate — plus Complete, Consistent, Enduring, Available. Exportable per record.
Validated onboarding
GAMP 5 Category 4 with URS/FS/DS traceability, IQ/OQ/PQ, and a signed validation summary report — delivered by V5, reviewed by your QA.
What 'GxP validated' looks like in the real world.
- First signed record within 30 days of kickoff — with validation evidence
- Zero-finding Part 11 audits on the audit trail and e-signature stack
- Independent 21 CFR Part 11 / Annex 11 assessment (Dr. Bob McDowall, Aug 2026)
- CSA-aligned test evidence: risk-based, not 400 pages of low-value scripts
- One instance covers GMP + GLP + GDP — no per-domain re-validation
GxP frameworks V5 is designed against.
21 CFR Part 11
§11.10(e) audit trail, §11.10(f) operational checks, §11.10(g) authority checks, §11.50 / §11.70 signature manifestation and binding — all native, all reviewable.
EU GMP Annex 11
Risk management, validation, data integrity, e-signatures, printed-copy criteria, incident management, business continuity — covered out of the box.
GAMP 5 Second Edition
Category 4 configured product with documented critical thinking. CSA-aligned test evidence delivered with onboarding — not a six-month after-the-fact project.
GxP software, answered.
What is GxP software?
GxP is the umbrella for FDA / EMA / MHRA / Health Canada 'Good x Practice' regulations — GMP (manufacturing), GLP (laboratory), GCP (clinical), GDP (distribution), GVP (pharmacovigilance). GxP software runs these workflows under electronic-record and e-signature controls (Part 11 / Annex 11).
Is V5 Ultimate GxP validated out of the box?
Yes. V5 ships as a GAMP 5 Second Edition Category 4 configured product, with URS/FS/DS traceability, IQ/OQ/PQ, and a signed validation summary — delivered by V5 on onboarding, reviewed and countersigned by your QA.
How does V5 handle 21 CFR Part 11 and EU GMP Annex 11?
Natively. Bound e-signatures, hash-chained audit trail, RBAC with author-cannot-self-approve, authority checks, printed-copy criteria — all covered without add-ons. See our validation page for the independent-assessment schedule.
Can V5 be hosted on-premises for validated clients?
Yes. Validated pharma and medical-device clients typically choose V5 Private Cloud (single-tenant Azure or AWS). On-premises deployment follows our published minimum-specification and self-install path.
Does V5 replace our CSV consultants?
It shrinks the scope. V5 delivers configuration-level IQ/OQ/PQ and CSA-aligned test evidence; your CSV team focuses on process-specific PQ and site-level SOPs — not on documenting our platform for you.
See V5 Ultimate handle a real GxP workload.
Free trial. Validation evidence included. Independent assessment published Aug 2026.