A validation is the documented proof that something is doing what is expected of it. Validation is therefore an integral part of every QM system. The different specialization of validation and IT experts often leads to multiple documentation efforts with superfluous, lengthy content.
Therefore a project accompanying validation is much more efficient than a retrospective validation. A meaningful documentation and test structure according to the "V-model" according to GAMP (Good Automated Manufacturing Practise) can bring these requirements together.
Although validation is often regarded as an annoying duty, it can - correctly planned and carried out - certainly provide valuable benefits:
- better understanding of processes through detailed planning
- lower risk of deviations and errors
- Errors are detected earlier
- better planned development process
- Additional project control without pressure to succeed due to the independence of validation
- Conformity with regulations, i.e. with internal processes that are repeated regularly.
- Systematic approach to problems instead of "ad hoc customizing" or "programming
- Detailed documentation of internal and external know-how