Our QMS Services Include
1. Document & Record Management:
Controlled document lifecycle: creation, approval, distribution, and archival Compliance with 21 CFR Part 11, EU Annex 11, and ALCOA+ principles Electronic document control systems integration
2. Change Control Management:
Structured approach to assess, document, and approve changes Impact analysis on quality, safety, and compliance Audit-trail-based tracking for transparency
3. Training & Qualification:
Competency-based training modules Role-wise training matrix and tracking Periodic refresher programs and compliance audits
4. Deviation & CAPA Management: Real-time deviation tracking Root cause analysis using tools like 5 Whys and Fishbone Preventive action implementation and effectiveness checks
5. Risk Management:
Risk identification, assessment, and mitigation Aligned with ICH Q9 and ISO 14971 standards Integration with project and process workflows
6. Internal Audits & Compliance Reviews:
Periodic audits to evaluate QMS effectiveness Gap analysis reports and remediation plans Support for regulatory inspections (FDA, WHO, EMA)
7. Supplier Quality Management:
Vendor qualification and audits Supplier scorecards and performance tracking Quality agreements and compliance assurance
8. Computer System Validation (CSV):
Validation lifecycle integrated into QMS Risk-based validation following GAMP 5 IQ/OQ/PQ protocols, traceability matrices, and summary reports