SoftQuest Systems offers comprehensive consulting for software verification & validation and software quality assurance in the medical device and the bio-pharmaceutical fields.
Computer and software validation standards at pharmaceutical, biotech and medical devices companies are under intense scrutiny by the FDA, CE and other regulatory bodies. As the regulators gain a deeper understanding of the safety risks involved in software development, they are continuously re-evaluating the computer and software validation standards. Knowing what needs to be validated and deciding how much validation is enough is a critical and challenging task for developers and manufacturers. As FDA, CE and other regulatory inspections become more stringent, it is essential that the changing guidelines and requirements are clearly understood and followed.
The basis of SoftQuest Systems validation is to provide documented evidence that the software developed has been verified and validated to ensure that they fulfill all regulatory expectations. Our approach to validation is pragmatic and emphasizes the significant value added.
We are very familiar with the industry standards and strive to satisfy all the regulatory requirements.
Software Quality Policy
and Validation (V&V)
Risk, Safety &
21 CFR Part 11