Medical Device Training in Malaysia – HRD Corp Claimable Course Scheme
Test Method Validation
INTRODUCTION / OBJECTIVES
Software Validation Requirements and Excel Spreadsheet Validation is a formalized, documented process for testing computer software and systems. The FDA and other regulatory bodies require Software and Excel Spreadsheet Validation to demonstrate that computer systems are in compliance with all regulations for electronic data management systems. Software and excel spreadsheets used in GMP or GLP environments, as with any computer system, the regulatory bodies expects measures to be in place to ensure system data are controlled and protected and to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. This training session shall explore the requirements for Software and Excel spreadsheets used in production or the quality system and case studies on how verification/validation can be accomplished.
COURSE OUTLINE
- Overview of Excel Validation System
1.1. Regulatory and QMS Requirements
1.2. Introduction to GAMP 5 requirements
1.3. 21 CFR Part 11 Regulations
- Types of Software/Computer Validation System
2.1. Computer System
2.2. Information System
2.3. Control System
2.4. Design system
- Software Category
3.1. Category 1 – Operating System
3.2. Category 3 – Standard Software Packages
3.3. Category 4 – Configurable Software Systems
3.4. Category 5 – Custom Built or Bespoke Systems
- Excel Spreadsheet Development Lifecycle
4.1. Project Planning.
4.2. Design
4.3. Development
4.4. Integration and Test
4.5. Installation and Acceptance
- Elements of Excel Spreadsheet Verification and Validation
5.1. Validation Master Plan
5.2. User Requirement Specification (URS)
5.3. Functional Requirement Specification (FRS)
5.4. Design Specification (DS)
5.5. Installation Qualification (IQ)
5.6. Operational Qualification (OQ)
5.7. Performance Qualification (PQ)
- Case Studies + Discussion
6.1. The “V” Model and how to apply it to software
6.2. Development of URS, FS, DS & Test Cases
6.3. Development of IQ, OQ and PQ protocols
6.4. Development of IQ, OQ and PQ report