GMP software that inspectors already know how to read.
V5 Ultimate is a full-lifecycle GMP platform for US and international manufacturers — cGMP under 21 CFR 210/211, EU GMP Parts I/II/III, WHO GMP and PIC/S. Batch execution, deviations, CAPA, change control, training, calibration and audit — one validated instance, one audit trail, one inspection.
You need GMP software because paper GMP is 30 years old — and it shows.
Documentation Chapter 4 is a shared drive with no version control
Deviations, CAPAs and change controls live in three different tools
Training records don't reference the SOPs the operator was trained on
Calibration status isn't checked before a critical measurement is signed
The audit trail can't answer 'who changed this value, when and why'
Every inspection prep rebuilds the same evidence packs from scratch
The GMP capabilities regulators actually inspect against.
Chapter 4 documentation
Controlled SOPs, work instructions, forms and specifications — with periodic review, effective dating and read-and-understood evidence.
Deviations & OOS
Phase-1 lab / Phase-2 manufacturing investigation model, root-cause tools, timers, escalations and CAPA linkage.
CAPA & change control
Root cause, action plan, effectiveness check, change-impact assessment — closed-loop with training, SOP and validation.
Training-to-role
Role assignments drive curriculum; every signed action checks current training on the SOP being executed.
Calibration & qualification
Instrument calibration status checked before every measurement is signed; qualification records for equipment and utilities.
Audit-trail inspector view
Read-only inspector mode filters by date, product or batch; signed evidence pack exports in one click.
What GMP looks like on one system, not six.
- Batch release from days to hours — deviations and CAPAs closed in the same window
- SOP effectivity + operator training checked at every Part 11 signature
- Calibration status enforced at data-capture — no signed reading from an out-of-cal instrument
- Zero-finding EU GMP and FDA cGMP inspections on documentation and audit trail
- Independent GAMP 5 / Part 11 / Annex 11 / GMP assessment publishing August 2026
The GMP regimes your site operates under.
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.
GMP software, answered.
What's the difference between GMP software and a QMS?
A QMS is one part of GMP software. Full GMP coverage also includes MES (batch execution), LIMS (lab), calibration, training-to-role, warehouse and equipment qualification. V5 delivers all of these on one platform under one validated instance.
Does V5 cover both FDA cGMP and EU GMP?
Yes — the same instance satisfies 21 CFR 210/211 and EU GMP Parts I/II/III. Procedural differences (e.g. QP release under EU) are handled by role and signature configuration, not by re-architecture.
How does V5 handle WHO GMP and PIC/S?
WHO GMP and PIC/S largely mirror EU GMP structure. V5 is deployed by sites inspected under PIC/S, WHO and national regulators (MHRA, HPRA, ANVISA, PMDA, TGA) with the same core configuration.
Is the audit trail really inspection-ready?
Yes. Hash-chained under §11.10(e), read-only inspector view, one-click signed evidence packs. V5 Classic has run under FDA/MHRA inspection for 15+ years with no Part 11 findings — Ultimate inherits the same posture.
What comes in the validation pack?
URS/FS/DS traceability, IQ/OQ/PQ scripts and executed evidence, validation summary report, and a shared-responsibility matrix. Delivered at onboarding, reviewed and countersigned by customer QA.
See GMP end-to-end on one platform — under real inspection load.
Free trial. Independent GMP / Part 11 / Annex 11 assessment publishing Aug 2026.