21 CFR Part 11- Software Validation 

This Software Validation course will also look at the 21 CFR part 11 ruling by the FDA  in relation to Electronic Records / Electronic Signatures.

Course Content:

Modules

Module 1 : Introduction to Software Validation

Module 2 :  Regulations and Guidelines for Software Validation

Module 3 : IQ/OQ, MVP, Protocol and Test Report 

Module 4 : Electronic Signatures and Records

Module 5: Software Validation Life Cycle

Module 6: COTS,MOTS and Custom Software

Module 7: User Requirement Spec

Module 8: Risk assessment

Module 9: How to Validate

Module 10. GAMP

Module 11. Change Control

Module 12. The future of Software Validation- CSA

Learning Objectives

Learners will have a complete understanding of why software Validation is necessary and have a better understanding of the process of providing documented evidence that an electronic system or technology will perform as specified  in relation to Electronic Records / Electronic Signatures