Confidence Beyond Compliance
QA and Compliance Consulting: From Planning through Implementation AND Maintenance/Monitoring
Our services include assistance with all aspects of developing and/or improving a Quality Management System from development of site quality plan through procedural development/revision to implementation including employee training. The Safis MDS team has expertise in all QMS elements including Management Controls, CAPA, Design Controls, Supplier Controls, Production and Process Controls and Post-Market Surveillance (Complaint Handling, Adverse Event Reporting and Recall Management).
Additionally, we provide our clients with Maintenance and Monitoring Services, including:
- Development of Quality Metrics
- CAPA Effectiveness (e.g., Records Reviews)
- Quality Auditing (to serve as company’s internal audit)
- Preparation for External Agency Inspections/Audits – gap assessments, mock audits, front room-back room set- ups, employee readiness training, assistance during inspection/audits.