1. DATA MANAGEMENT AND IT IN BA/BE STUDIES DR. SHIVPRAKASH MANAGING DIRECTOR SYNCHRON RESEARCH SERVICES PVT. LTD., INDIA

2. SYSTEMS IN BE ENVIRONMENT ANALTICAL DATA PK ANALYSIS ARCHIVING LIMS ANALYTICS SOFTWARE

3. IT NEEDS Technology is same but needs are different for: 1.Analytical 2.Clinical 3.Project management

4. ANALYTICAL NEED Data acquiring software’s eg., Masslynx, Empower, Easychrom etc.. LIMS eg., Watson LIMS, custom made and in- house systems Archiving systems eg., Nugenesis, Veritas etc.,

5. IT OVERVIEW

6. CLINICAL NEEDS Oracle Visual Basic SAS Kinetica Windows Nonlin Microsoft tools for project management

7. IT ISSUES 1.Supply of data acquisition systems which are 21 CFR Part 11 compliant- key components to look for in software are audit trail, authentication and validation. 2.Data security and data integrity remain critical IT issues- electronic data can be pretty vulnerable because they are replacing all the paper data. 3.Record retention (with respect to server design) and systems that maintain audit trails continue to be a challenge. IT is unaware of security and GxP system requirements.

8. REGULATORY RESPONSE USFDA responded to these problems and came out with 21 CFR Part 11 ruling, which has adopted a risk- based approach to compliance. This has given companies a starting point to their validation strategies

9. WHY VALIDATION? Unknown Errors Unknown suppliers –Software –Hardware –Peripherals –Patches –Other IT related supplies

10. VALIDATION…. Validation and audit trail are areas requiring particular attention. Validation of computerized systems is required if the system can potentially affect product quality, safety and the integrity of Part 11 records. Validation includes all components of a system, software, hardware and documentation, and is a continuous process.

11. GENERALIZED COMPUTER SYSTEM VALIDATION

12. VALIDATION OF COMPUTER SYSTEMS IN A CRO MAKES A GOOD BUSINESS SENSE AND IT REFLECTS THE URGENCY AND INTEGRITY OF THE COMPANY

13. IT GOVERNANCE OBJECTIVES IT alignment: Ensuring that IT is fully aligned with the organization’s business objectives. IT accountability and ownership: Ensuring that this is clearly and appropriately communicated throughout the organization. IT resource management: Ensuring that IT practices are efficient in comparison with peer organizations consistently used across the organization. IT risk management: Ensuring that compliance risks are identified and addressed through risk mitigation, elimination, transfer or acceptance. IT performance monitoring and improvement: Constantly monitor for more answers.

14. THANK YOU