Computerised systems validation is essential for medical device and pharmaceutical manufacturers. Here, Beth Peckover, VP Global Delivery at Kallik, pinpoints the three areas businesses need to get right to ensure computerised systems used for labelling meet all GxP requirements set out by industry regulators.
Pharmacy
Validation of computerised systems is a non-negotiable requirement enforced by regulators such as the FDA in the US, EMA in Europe, TGA in Australia, and HS-SC in Canada. The ability to demonstrate adherence to appropriate practice and processes that underpin a quality driven, risk-based approach to computerised systems validation is a pre-requisite to being able to operate in any highly regulated market, including medical device and pharmaceutical manufacturing.
As part of GxP regulations, manufacturers involved in these highly regulated industries must adhere to good manufacturing practices (GMP) defined as “a system of processes, procedures, and documentation that help ensure that products are consistently produced and controlled according to quality standards.” It’s necessary to zero in on GAMP 5 guidance for GxP computerised system compliance and validation – this is the standard regulators work to.