Pharma QMS · 21 CFR 211 · EU GMP · ICH Q10
Pharma QMS software for deviations, CAPA and APR/PQR.
Deviations, CAPA, change control, APR/PQR, training and supplier quality organised around 21 CFR 211, EU GMP and ICH Q10, with people deciding disposition.
Deviations + CAPA
APR / PQR Automation
Supplier Quality
Data integrity (ALCOA+)
Full product detailCommon problems, what's included, why teams choose it, and where commercial meets regulated.
You need a pharma QMS because the last inspection cited data integrity or CAPA effectiveness.
Deviations open days after the failing step, not at it
CAPA effectiveness checks are theatre, not evidence
APR / PQR is a Q1 fire drill — 40 files, 3 analysts, missed deadline
Supplier qualification lives in an inbox, not a system
Training compliance can't be shown per SOP, per role, per shift
An FDA 483 asked how you'd know your process was in control — and you couldn't
The pharma QMS process set — configured against 21 CFR 211 and ICH Q10.
Deviations + CAPA
Trigger at the failing step from the eBR, structured RCA, effectiveness checks scheduled and evidenced under §211.192.
APR / PQR Automation
Annual Product Review / Product Quality Review draft generated from batch, deviation, complaint and stability data — analyst edits, doesn't assemble.
Supplier Quality
Qualification, scorecards, audit calendar, incoming inspection results — with change-notification workflow.
Data integrity (ALCOA+)
Attributable, contemporaneous, original, accurate — every record, exportable per audit-trail package.
What a working pharma QMS actually delivers.
- APR / PQR cycle time cut from months to days — with drafted narrative
- Audit trail and e-signature records your QA can review and export for an inspection
- Inspection records you can find by batch, lot or date — reviewed by your team before anything is shared
- ICH Q10 PQS elements evidenced end-to-end, not just claimed
Pharma QMS aligned to every regime you're inspected 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.
Pharma QMS software, answered.
What is pharma QMS software?
A Quality Management System designed for pharmaceutical manufacturers — running deviations, CAPA, change control, APR/PQR, training and supplier quality under 21 CFR 210/211, EU GMP Part I, ICH Q10, and MHRA requirements, on a platform built for Part 11 / Annex 11 controls that your team validates for its use.
Does V5 automate APR / PQR?
Yes. Analysts review and finalize — they don't assemble.
Is V5 aligned to ICH Q10?
Yes — the QMS is modeled as a Pharmaceutical Quality System with the four ICH Q10 elements (process performance & product quality monitoring, CAPA, change management, management review) evidenced end-to-end.
Capabilities vary by plan and setup. Confirm specifics with our team before relying on them.
See V5's pharma QMS handle a real deviation-to-CAPA cycle.
Free trial. APR / PQR drafted, not assembled.