Roche was satisfied that Perceptive's products and support meet the requirements of computerised systems used for FDA 21 CFR part 11 compliant GxP activities within the pharmaceutical industry
A recent successful vendor audit from Hoffman-La Roche of Perceptive Instruments's Ames Study Manager, Sorcerer Colony Counter and System Access Manager systems has reinforced the company's reputation for producing quality software that adheres to the strict principles of regulatory compliance, it says.
The audit focused on its quality management system, which meets the international standard ISO 9001:2000 and TickIT, particularly with reference to support structure and product lifecycle.
Roche's representatives were satisfied that Perceptive's products and support structure meet the exacting requirements of computerised systems used for FDA 21 CFR part 11 compliant GxP activities within the pharmaceutical industry, and the firm is now an approved supplier for F Hoffman-La Roche .
Perceptive Instruments says all its systems are designed to fulfil the requirements of good laboratory practice, FDA 21 CFR part 11 and other international regulatory requirements.
As part of its ongoing commitment to these principles, it provides expert support and all project, test and installation qualification documentation to assist with validation processes.
With over 75% of our sales made outside the United Kingdom, Perceptive Instruments has a wealth of experience in supporting systems throughout the world.
