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.
QA and Compliance Consulting
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