GxP · GMP · GLP · GCP · GDP · Part 11 · Annex 11
GxP software with validation evidence your QA can review, not a year-long documentation project.
Part 11 and Annex 11 controls, audit trails and validation evidence your QA team reviews and approves. IQ/OQ support is available on Enterprise plans.
GMP Manufacturing
GLP Laboratory
GCP Clinical Supply
GDP Cold Chain
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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
Every 'GxP' vendor demo skips the audit-trail export
Inspectors flagged contemporaneity, attributability, or originality
What's included
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.
Validation Support
Your QA decides the validation approach and approves it.
Why teams choose it
- Audit trail and e-signature records your QA can review and export for an inspection
- Independent 21 CFR Part 11 assessment of V5 Ultimate 5.10 (Dr. Bob McDowall, Sept 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 — software controls that support your Annex 11 approach; validation and procedures remain yours.
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).
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.
Does V5 replace our CSV consultants?
No.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See V5 Ultimate handle a real GxP workload.
Free trial for evaluation. IQ/OQ and validation support are available with Enterprise.