Validatingcomputerisedsystem com

04-Dec-2015 18:27

Pro Pharma Group’s support begins with a group of highly qualified and experienced consultants.

We staff projects based on required expertise and scope, providing the most efficient and cost effective CSV services possible.

QA Professionals specialising in computer compliance are highly sought after, especially in the newer areas of the Gx Ps, such as GPv P.

The reliance on computer systems by all functions results in wide-ranging interactions with QA, and therefore the QA Professionals have opportunities for interactions with senior staff across functions.

Key computer systems are usually located at central sites for an organisation, but some travel will usually be required for assessing computer system vendors and also local systems operating at local company sites.

Pro Pharma Group provides a broad range of Computer System Validation (CSV) services in support of our clients’ manufacturing, laboratory, and enterprise systems.

This testing of computer systems is called ‘validation’, and QA professionals are involved in the overall validation process in a variety of different ways.

It is a regulatory requirement to ensure that all systems used to store and/or manipulate clinical data are ‘fit for purpose’ and fully validated prior to use, and at intervals during the system’s lifetime.

Computer systems may be commercially available or developed in-house.

QA Professionals will work with systems regardless of origin, if they support regulated activities in some way: The fact that computer systems are embedded across all aspects of companies involved in research and development means that QA Professionals interact with many different groups within the organisation and outside it.

In this Labcompliance Info we can give a couple of recommendations although the final decision will depend on the specific situation of each organization.