Most of the more complex computer systems employed by life-sciences firms are in some way customized. Even those who rely on vendor-assembled systems often find themselves having to tweak [...] Read More
CSV (Computer System Validation) compliance is something that the FDA and the European Regulatory Authorities take very seriously. Software programs that are not in compliance with validation and the associated infrastructure qualification measures could result in a product recall by the government.
Regardless of whether a software program is developed by a company itself or is purchased off-the-shelf, it should have a defined objective before it is used for a specific [...] Read More