GAMP5, 2nd version from July 2022
Changes to first edition:
The new GAMP5 second edition is an iterative and behavior driven approach. It focuses on CSA rather than on CSV
It recognises the largely non-linear, agile and more cyclical nature of modern software development
Automated testing SasS solutions like CircleCI and GitHub, (Veeva) simply don’t produce IQs, OQs or PQs
GAMP 5 Second Edition embraces and reflects:
- Increased importance of service providers, which includes encouraging regulated companies to maximize supplier involvement to leverage knowledge, experience, and documentation where possible
- Evolving approaches to software development, emphasizing that the GAMP specification and verification approach is not inherently linear but also fully supports iterative and incremental methods
- Increased use of software tools and automation to achieve greater control, higher quality, and lower risks throughout the life cycle
Education
Dipl.-Ing (FH) Chemieingenieur
Certificate of the Postgraduate Program Bioinformatics
S k i l l s
Scientific Data Management
Computer System Validation
Data Integrity
Data Governance
