VALIDATION OF SOFTWARE (CHANGE MANAGEMENT SOFTWARE) USED FOR COMPLIANCE WITH REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES

1. VALIDATION OF SOFTWARE (CHANGE MANAGEMENT SOFTWARE) USED FOR COMPLIANCE WITH REGULATORY REQUIREMENTS IN PHARMACEUTICAL INDUSTRIES Devesh Sharma M. Pharm (DRA) [email_address]

2. CMS Quality management system: change control Industry specific solution Business ready with regulatory compliance

3. A comprehensive client server based tool that enables organization to effectively manage changes to process, documents (STPs/ SOPs/ Procedures), facilities, hardware, software, engineering, products, equipments, protocols and other areas. Specifically designed for pharmaceutical Mfg. units and to ensure compliance.

4. CMS centralizes and automates the change control process across the entire organization.

7. PROJECT DESCRIPTION

8. This is a Operational / Performance Qualification protocol, for software package CMS (21 CFR Part 11 compliant) The validation involved Operational/ Performance qualification activities for CMS in order to ensure that it functions consistently according to pre determined specifications.

9. Aim of present work To provide record of the key features of the software as currently installed; To ensure that there was sufficient information available to enable the software to be operated and maintained safely, effectively, and consistently; To generate qualification protocol document for CMS

10. Scope This qualification protocol covered the multi user version of CMS located in facility.

11. How is validation done General validation activities cycle

12. V-Model to illustrate how all aspects of validation process integrate tightly

13. Which computer systems need to be validated? Any computer systems that involves GxP application, requires validation.

14. Steps in identifying GxP computer systems

16. OQ / PQ QUALIFICATION TEST SHEETS These included: Test step ID Test step objective Instructions / Input Expected results / output Actual result

17. Results The software system CMS met with the predetermined requirements; it qualified operationally.

18. Future aspects Pharmaceutical industry has, as has the rest of the world, been dramatically impacted by information technology and data processing concepts. There is hardly any area in the industry where need of computerization is not felt.

19. Software systems are being increasingly accepted as an essential part of a modern, progressive pharma industry and organizations. Industries are opting to get most of their operations computerized including quality assurance, quality control, production, sales, training and development etc. Change management: an integral part of all activities.