Topics
- Which software needs validation and which does not?
- How to avoid 483 and Warning Letters
- What the regulations mean, not just what they say
- GAMP, qualification, and validation
- Current computer system industry standards for security, data transfer, audit trails, and electronic signatures
- Regulatory requirements for the three primary areas of Part 11 compliance: SOPs, software product features, and validation documentation
- Computer system validation
Common Problems with Software Validation Processes brings together QA, IT, Laboratory staff, QC, GMP, GCP, GLP professionals and Managers.
