Services

Good Manufacturing Practices (cGMP)

  1. Backup and Recovery
  2. Change Control 
  3. Control of Lab Notebooks
  4. Design Control
  5. Device Master File
  6. Good Documentation Practices
  7. Installation Qualification (IQ)
  8. Operational Qualification (OQ)
  9. Performance Qualifications (PQ)
  10. Training

Good Clinical Practices (cGCP)

  1. Cleaning Clinical Study Data
  2. Conduct of a Pre-Study Visit
  3. Database Close Procedures
  4. Database Quality Control
  5. Develop a Statistical Analysis Plan
  6. Deviation Reporting
  7. Filing and Archiving of Records 
  8. Good Documentation Practices
  9. Master Audit Plan
  10. Vendor Audits

Good Laboratory Practices (cGLP)

  1. Business Continuity
  2. Change Control
  3. Confidential Disclosure Agreements
  4. Corrective and Preventive Action (CAPA)
  5. Defining Customer Requirements
  6. Internal Audit
  7. PCNA ELISAs
  8. Quality System Planning
  9. Record Retention
  10. Regulatory File Management

The above list represents a sampling of our SOPs. To learn more about our full list of SOPs e-mail us at SOPs@Safis-Solutions.com or contact us by phone at (317) 777-6200.