Supplier Quality & Assessment
Supplier qualification, audits, risk assessment, performance and supplier corrective action.
12 articles
- Medical Device Supplier Qualification and Audit Checklist Under QMSR Outsourcing and purchasing is FDA's #2 QMSR finding. Use this supplier qualification, audit and quality agreement checklist built for 2026 inspections.
- Supplier Performance Management: Metrics, Scorecards and Reviews for Regulated Manufacturers How pharma and device makers monitor supplier performance: what regulators require, which KPIs matter, how to build a scorecard and when to act.
- Supplier Risk Assessment: Methods, Criteria and Software for Life Sciences How to assess supplier risk in pharma and devices: risk factors, scoring, EU excipient guidelines, FDA's DEG/EG expectations and supplier risk software.
- Supplier Quality Management: Requirements, Process and Software The supplier quality management lifecycle in pharma and devices: 21 CFR 211, ICH Q10, EU GMP and ISO 13485 requirements, FDA citations and SQM software.
- Supplier Evaluation and Qualification: A Step-by-Step Guide for GMP and Medical Devices A step-by-step supplier evaluation and qualification process for pharma and device makers: criteria, evidence, approval, requalification and FDA findings.
- Supplier Audits: Planning, Conducting and Following Up, With Software Options How to plan and run supplier audits in pharma and devices: risk-based frequency, scope, reports, follow-up, the QMSR change on audit reports, and software.
- Supplier Compliance and Document Review: What to Check and How Often What supplier compliance means in pharma and devices, which supplier documents to review, how to verify certificates of analysis and keep files current.
- Supplier Corrective Action Requests (SCAR): How Supplier CAPA Should Work How to issue and manage supplier corrective action requests in pharma and devices: when to raise a SCAR, what a good response holds and how to verify it.
- Supplier Assessment Automation and AI: What Can Be Automated in Supplier Quality What can be automated in supplier quality, where AI helps review supplier documents and spot risk signals, and the controls expected under draft Annex 22.
- Medical Device Manufacturing in 2026: Regulations, Tariffs and Automation QMSR is in force, tariffs are reshaping supply chains and automation is rising. What US medical device manufacturers need to know in 2026.
- Medical Device Audits in 2026: Internal, Supplier, Notified Body and MDSAP Internal, supplier, notified body and MDSAP audits explained, plus what QMSR and ISO 19011:2026 change for medical device audit programs.
- GMP Audits: How to Plan and Run Internal, Supplier and Mock Inspection Audits How to plan and run GMP audits: self-inspections, supplier and CMO audits, and mock FDA inspections, with the six-system scope and a checklist.
Subjects covered
- supplier quality management
- supplier quality management software
- supplier quality assessment
- supplier risk assessment
- supplier qualification
- supplier audit
- supplier audit software
- supplier evaluation
- supplier compliance
- supplier quality audit
- supplier quality assurance
- supplier performance management