It deals with development and validation of software used in medical devices.
More recently the FDA has released a draft guidance ob using computers in clinical studies (3).
Isn’t that why you bought the computer system in the first place?
Pro Pharma Group provides a broad range of Computer System Validation (CSV) services in support of our clients’ manufacturing, laboratory, and enterprise systems.
We bring a full understanding of pharmaceutical, biotechnology, and medical device business processes to a practical, risk-based approach to CSV.
By verifying the controlled development and implementation of computer systems, we can help our clients ensure the integrity, reliability, and availability of their regulated business data to support the production of quality products and ultimately protect patient safety.
Pro Pharma Group’s support begins with a group of highly qualified and experienced consultants.