This module introduces the student to fundamental aspects of computer systems validation for pharmaceutical and biopharmaceutical manufacturing environments. The topics covered include the development of a risk-based plan for computer system validation (CSV) lifecycle activities for a computerized system based on the product and process; the maintenance of the integrity, consistency and completeness of the operational controls for a computerized system in accordance with the principals of GAMP (Good Automated Manufacturing Practices); and the application of good data and electronic record management techniques to assure the integrity and authenticity of data, electronic records and signatures.
The indicative syllabus covered in the module and/or in its discrete elements:
1. Good Automated Manufacturing Practices (GAMP) software categories and classification of laboratory systems for a range of computerised systems in regulated environments.
2. Typical End-User and Supplier Activities, and Validation Planning, and Tasks Supporting Validation
3. Specification and Verification - System Development versus System Implementation Life Cycle
4. Science Based Quality Risk Management
5. Major information flows and process relationships between operational activities
6. Information technology (IT) compliance for infrastructure elements of computerised systems
7. Patch and update management, retirement of computerized systems, data migration, electronic data archiving, and system retirement
8. Electronic record content, structure and context, and record anatomy, and controls to maintain electronic data and record integrity
9. Regulated records and signatures required by 21 CFR Part 211, 21 CFR Part 820 and ICH Q7, complying with 21 CFR Part 11, and data integrity.
10. Industry 4.0 (Pharma 4.0) technologies: creating intelligent networks along the value chain whereby interconnected machines and systems control each other.
Computer Systems Validation
Good Automated Manufacturing Practices (GAMP) software categories and classification of laboratory systems for a range of computerised systems in regulated environments.Typical End-User and Supplier Activities, and Validation Planning, and Tasks Supporting ValidationSpecification and Verification - System Development versus System Implementation Life CycleScience Based Quality Risk ManagementMajor information flows and process relationships between operational activitiesInformation technology (IT) compliance for infrastructure elements of computerised systemsPatch and update management, retirement of computerized systems, data migration, electronic data archiving, and system retirementElectronic record content, structure and context, and record anatomy, and controls to maintain electronic data and record integrityRegulated records and signatures required by 21 CFR Part 211, 21 CFR Part 820 and ICH Q7, complying with 21 CFR Part 11, and data integrity.Industry 4.0 (Pharma 4.0) technologies: creating intelligent networks along the value chain whereby interconnected machines and systems control each other.
Lectures, case studies, workshops, webinars
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Other Assessment(s) | 100 |