cGMP software an FDA investigator can walk through in a morning.
V5 Ultimate is the current-Good-Manufacturing-Practice platform US, UK and Canadian manufacturers deploy to close the gap between paper SOPs and a defensible 21 CFR 210/211/820 record. Signed eBRs, deviations, CAPA, calibration, training, supplier quality — one validated instance. Live in 30 days.
You need cGMP software because paper-and-Excel just failed a §211 walk-through.
Batch records rely on operator memory and end-of-shift entry
Master production records live in Word — with no version control
Calibration records surface after equipment is used out-of-cal
Training records can't map to the SOP an operator signed
OOS handling doesn't meet §211.192 investigation standards
The audit trail can't survive an ALCOA+ challenge
cGMP capabilities mapped subpart-by-subpart against 21 CFR 211.
Master + batch records (§211.186 / §211.188)
Version-controlled MPRs, contemporaneously signed BPRs, in-process controls captured at the step, not retroactively.
Equipment + calibration (§211.68)
Calibration due-dates block use of out-of-cal instruments; usage logged per batch, per operator, per step.
Personnel + training (§211.25)
Role-based training tied to SOP versions; retraining triggered on revision; competence evidence per person, per shift.
Investigations (§211.192)
OOS / deviation investigations with structured RCA, extent-of-batch review, effectiveness verification — all Part 11 signed.
Components + suppliers (§211.84)
Incoming inspection, C-of-A verification, supplier qualification, change-notification workflow.
Records + reports (§211.180 / §211.194)
Retention timers, laboratory records complete under §211.194, Part 11-compliant audit-trail export for any inspector.
cGMP results V5 clients see in the first year.
- First signed batch record within 30 days of kickoff
- Contemporaneous data capture eliminates §211.100 contemporaneity findings
- §211.192 investigations closed in days, not weeks
- One-click inspection dossier for any product, any date range
- Independent 21 CFR Part 11 / Annex 11 assessment publishing Aug 2026
cGMP 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.
cGMP software, answered.
What is cGMP software?
Software that runs the workflows required by current-Good-Manufacturing-Practice regulations — 21 CFR 210/211 for drugs, 21 CFR 820 (now QMSR from Feb 2026) for medical devices, and equivalent EU GMP / MHRA / Health Canada rules — under Part 11 electronic-record and e-signature controls.
Does V5 cover both drug cGMP (211) and device cGMP (820 / QMSR)?
Yes. The same V5 instance runs 21 CFR 211 pharmaceutical workflows and 21 CFR 820 / QMSR device workflows — customers in combination-product businesses deploy one platform, not two.
How is cGMP different from GMP?
'cGMP' is the FDA's term — the 'c' means 'current' and signals that manufacturers must keep pace with evolving industry standards, not just meet the letter of the 1978 rule. In practice, cGMP and GMP describe the same regime; other regulators (MHRA, PIC/S) usually just say 'GMP'.
Is V5 validated for cGMP use?
Yes. V5 ships as a GAMP 5 Second Edition Category 4 configured product with CSA-aligned test evidence and IQ/OQ/PQ delivered on onboarding — the validation pack goes with the instance.
Can V5 replace paper batch records for cGMP?
Yes — that's the primary deployment pattern. Master Production Records, Batch Production Records, in-process controls, deviations and release checks all move to signed electronic form under §211.186 / §211.188 / §211.192.
See V5 run a real cGMP batch — end to end.
Free trial. Validated in 30 days. No 12-month CSV project.