Quality
A quality system that can answer the question.
When your auditor asks who approved revision C, the answer is one click away — with the change, the reviewers, the signatures and the training that followed.
From nonconformance to closed CAPA, in one thread.
NCMRs, CAPAs, complaints, deviations, audits, management review and risk — linked, staged and signed. Built for ISO 13485, MDSAP and 21 CFR Part 11.
Built for medical device quality systems
- ISO 13485
- MDSAP
- 21 CFR Part 11
- 21 CFR Part 820
Document control
Controlled documents and the changes that revise them. Built for ISO 13485 §4.2.4, MDSAP and 21 CFR Part 11.
- Documentation library
- SOPs, work instructions, forms and attachments, each with its revision history and effective date.
- Document change records
- Create, revise, transcribe or withdraw documents with redlines. Sign-off rules decide who signs, seat by seat.
- Training
- A released revision assigns training to every job it affects: read-and-sign, quizzes graded on the server, group sessions and refreshers.
- Training plans and qualifications
- Plan the year's sessions for management review, and keep each person's certificates and skills with their evidence and expiry.
- Standards coverage
- Every clause of the standards you serve, with the documents that cite it. Gaps show before the audit does.
Quality assurance
The quality events of a medical device company, linked from first report to verified fix.
- Nonconformances (NCMR)
- Containment, MRB review and disposition — with split dispositions, standing dispositions and return-to-vendor shipments.
- CAPA
- Investigation with 5-Why and cause codes, actions with owners and due dates, extensions and effectiveness checks.
- Complaints
- Reportability for each market, deadlines from a controlled table of reporting rules, regulatory reports and field action assessments.
- Deviations
- Planned, approved departures from a released procedure — bounded by dates and quantity, never longer than 90 days.
- Change requests
- Changes to equipment, tooling, suppliers, parameters or materials. The impact assessment creates every follow-up the change needs.
- Audits
- Audit programs, checklist templates, audits and findings that feed straight into CAPA.
- Management review
- Reviews with attendees, inputs and actions, plus quality objectives and their results.
- Risk management
- Risk management files, plans and reports, process risk assessments and failure modes, with triggers that ask for a new review.
- Trend alerts
- Defect codes across nonconformances and complaints, with an alert when a trend crosses its limit.
Suppliers
The approved supplier list and the evidence behind it.
- Approved supplier list
- The suppliers you are allowed to buy from, each with its evaluations, change notices and SCARs.
- Supplier evaluations
- Score suppliers against criteria sets that you define, and keep the result with the supplier.
- Supplier change notices
- Record what a supplier is changing and how much notice it gave.
- SCARs
- Supplier corrective action requests, linked to the nonconformance that raised them.
Also on the platform
See Artifice on your own processes.
Tell us what you build and where it hurts today. We will walk you through the platform with your records, not a generic script.
Book a demo