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.
Computer system validation is a topic which many people think is complicated, usually because they are simply not familiar with the basic principles.
Consequently QA Professionals working in this area will find many opportunities for providing consultancy and training to the user communities, which may be a CRA trying to assess whether an investigator’s records system at a site complies with basic validation requirements, or a Site Director wanting assurance that the systems in use at that site will pass regulatory scrutiny.
However a lot of QA professionals cover validation of computer systems as part of their routine Gx P QA roles, so computing QA is a truly diverse aspect of QA.
Depending on the structure of the organisation, the role may be interacting with pre-clinical functions such as toxicology and molecular modelling, clinical research functions such as Pharmacovigilance or Data Management and Biometrics, manufacturing functions and IT.
The roles may be very varied, perhaps from auditing a server room one day then auditing a validation pack or providing consultation services for regulatory inspection preparation the following day, or quite specific, e.g., just involvement in validating GCP IT 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.
Once a system is in use it is usual to re-visit the vendor on a regular cycle to assure they are maintaining the standards set for updates to the system.