cGMP · EU GMP · WHO GMP · PIC/S · One Platform
GMP software with records inspectors can follow end to end.
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.
Chapter 4 documentation
Deviations & OOS
CAPA & change control
Training-to-role
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
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 view filtered by date, product or batch, so your team can find and review records.
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
- Audit trail and e-signature records your QA can review and export for an inspection
- Independent 21 CFR Part 11 / 21 CFR 211 assessment of V5 Ultimate 5.10 (Sept 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 — software controls that support your Annex 11 approach; validation and procedures remain yours.
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.
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.
What validation support is included?
V5 supplies the product controls and records; you decide intended use, validation approach, approval and release.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See GMP end-to-end on one platform — under real inspection load.
Free trial. Independent Part 11 / 21 CFR 211 assessment available (Sept 2026).