COMPUTER SYSTEM/PLC/SCADA VALIDATION

In the pharmaceutical sector, CSV is crucial for enhancing product quality, improving process performance, and supporting high-quality goods. The primary advantage of the CSV is providing quality controls, which help to prevent manual error and ensure that the process is carried out correctly.

European Medicines Agency (EMA) and Food and Drug Administration (FDA) both produced guidelines for CSV Practices. In the pharmaceutical industry, CSV is a unique process that maximizes effectiveness and enhances quality. CSV saves cost as well as time.

1. SOP for Performance Verification of Calculator & Excel Sheet
2. Installation Qualification of Computer
3. User Requirement Specification for Computer
4. Computer System Risk Assessment Plan
5. Computer System Validation Plan
6. Computer System Initial Risk Assessment
7. Computer System Installation Qualification
8. Computer System Operational and Performance Qualification
9. Traceability Matrix of Computer System
10. IQ for PLC Validation of 51 Station Double Rotary Machine
11. URS for Lab Solutions Software of HPLC
12. Operational Qualification for PLC System of Purified Water Generation System
13. Operational Qualification for PLC System of Purified Water Distribution Loop System
14. SOP for Operation of PLC HMI System
15. Installation Qualification Protocol Cum Report for PLC for Autocoater 66
16. Operational Qualification Protocol Cum Report for PLC Validation of Auto-Coater 66
17. SOP for Computer System Validation
18. Appendix 1-Template of Inventory List for Computerised System
19. Appendix 2a-Template of URS_SRS
20. Appendix 2b-Template of Basic Vendor Assessment
21. Appendix 2c-Template of Vendor Assessment
22. Appendix 2d-Template of System Assessment
23. Appendix 2e-Template of GxP Assessment
24. Appendix 2f-Template of GAP Assessment
25. Appendix 2g-Template of Validation Plan
26. Appendix 2h-Template of FCS_FDS
27. Appendix 2i-Template of Functional Risk Assessment
28. Appendix 2j-Template of IQ_OQ_PQ
29. Appendix 2k-Template of Discrepancy Form
30. Appendix 2l-Template of Validation Summary Report
31. Appendix 2m-Template of Periodic Review
32. Appendix 2n-Template of Retirement Protocol
33. Appendix 2o-Template of IT Infrastructure Qualification_NQ
34. Appendix 3-Template of Computerized System Periodic Review Log
35. Appendix 4-Template of Computerized System progress Report
36. Appendix 5-Template of Document number assignment for logbook
37. Appendix 6- Template of Computerized System Assessment
38. Appendix 7 Template of Validation Document Number Request Form