Validation means 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 - if well planned and carried out - provide valuable benefits, e.g.:
- better understanding of processes through detailed planning
- lower risk of deviations and errors
- early detection of errors
- better planning of the development process
- additional project control without pressure to succeed due to the independence of validation
- conformity with regulations, i.e. with internal processes which are repeated regularly
- systematic approach to problems instead of "ad hoc" customizing or programming
- detailed documentation of internal and external know-how