ISO 9001 · ISO 13485 · MHRA GMP · UKAS-audited clients
QMS software for UK manufacturers working to ISO 9001, ISO 13485 and GMP.
One quality system for the records your auditors sample.
Document control with real revision discipline
Draft, review, approve, issue and withdraw with electronic signature.
Training tied to the document that changed
A new revision automatically assigns read-and-understood tasks to the affected roles, with a competency matrix showing who is qualified for what,…
CAPA that has to prove it worked
Root cause method, action plan, owner, due date, verification and a scheduled effectiveness review before closure is permitted.
What goes wrong today3 common problems
The Quality System Lives in SharePoint and Spreadsheets
Controlled documents in one place, CAPAs in another, training in a third. Nothing reconciles at audit time.
CAPAs close without effectiveness evidence
The most common ISO 9001 and 13485 finding is a CAPA closed on assertion rather than on demonstrated effect.
Training Records Lag Behind Document Revisions
A revised SOP with no read-and-understood record against the current version is an immediate non-conformity.
Everything V5 does here5 capabilities
Document control with real revision discipline
Draft, review, approve, issue and withdraw with electronic signature. Superseded copies are removed from circulation, and the current version is the only one an operator can open.
Training tied to the document that changed
A new revision automatically assigns read-and-understood tasks to the affected roles, with a competency matrix showing who is qualified for what, today.
CAPA that has to prove it worked
Root cause method, action plan, owner, due date, verification and a scheduled effectiveness review before closure is permitted.
Internal Audits and Management Review
Audit programme, findings, responses and the management-review inputs assembled from live data instead of a pre-meeting scramble.
Supplier Approval and Monitoring
Approved supplier list, questionnaires, certificates with expiry alerts, incoming inspection results and supplier scorecards in one place.
Standards Referenced
- ISO 9001:2015
- ISO 13485:2016
- EU GMP Annex 11 / MHRA GxP data integrity guidance
- 21 CFR Part 11 (for US-facing sites)
- UK MDR 2002 (as amended) for device manufacturers
Common questions5 answers
- What should QMS software cover for a UK manufacturer?
- Document and record control, non-conformance, CAPA, complaints and vigilance, internal audit, management review, training and competency, supplier approval, calibration and change control — with electronic signatures and a complete audit trail.
- Does V5 suit ISO 13485 as well as ISO 9001?
- Yes. The same core processes carry the extra 13485 expectations — risk management links, design and development records where in scope, complaint handling with vigilance decision-making, and stricter traceability.
- How does V5 handle MHRA data integrity expectations?
- Records are attributable, legible, contemporaneous, original and accurate pairing: identity on every entry, no overwrite of original values, and a tamper-evident audit trail — the ALCOA+ set the MHRA guidance describes.
- Can it be hosted in the UK?
- Yes — regulated enterprise clients run a single-tenant private cloud, with a UK region available.
- Do we have to move everything at once?
- No. Most UK sites start with document control and CAPA, then bring audits, training and supplier management across as the first processes settle.