Validation
- User Requirements/Specifications
- Design Qualifications
- Installation Qualifications
- Operational Qualifications
- Process and Product Performance Qualification
- Validation Master Planning
- Electronic data integrity validation
- Computer Systems validation
- Factory and Site Acceptance Testing
Our experienced validation staff is your ready resouce in all aspects of the validation life cycle. We judge our protocol quality by scientific methodology, purpose and content.... not by the pound.
| 1. Review | Periodic review of validated systems,calibration program, PM, process control monitoring, maintain validation master plan. |
| 2. Change | Change or validation required (new or existing). |
| 3. Initiate Project | Initiate project with owner approval. |
| 4. URS | Requirements & Specifications (owner & QA approval) |
| 5. DQ | Design Qualifications |
| 6. IQ/OQ | IQ/OQ Protocol (owner & QA approval ) |
| 7.IQ/OQ Execution | IQ/OQ Execution (owner & QA approval ) |
| 8. Verify | Verify test methods are validated & test equipment qualified and calibrated. |
| 9.SOP & Training | Procedures and SOPs written, training documented, PMs written and scheduled. |
| 10.PQ Approval | PQ Protocol (owner & QA approval ) |
| 11. PQ Execution | PQ Execution (owner & QA approval ) |
| 12. Verify Docs | Verify documentation of all supporting activities. |
| 13. Final Approval | Final approval and documentation storage. |
| 14. Mfr. | Product completed begin manufacturing |