The all about Computer System Validation in Pharmaceuticals.

Computer system validation is the process of ensuring that any technology component (software or hardware) is fulfilling its purpose in line with the regulatory guidelines for a certain industry. It is especially crucial in FDA-regulated industries like Biotech and Pharma, since products from these sectors impact public health and safety. Talk to us for CSV in pharma and Life science industry.

Why is Computer System Validation necessary?

Computer system validation is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality.

It’s essential to maintain quality standards in pharma since non-conformance can have far-reaching consequences. Computer system validation checks the effectiveness and the efficiency with which the system is meeting the purpose for which it was designed.

Processes required for Computer System Validation – CSV Pharma

Computer system validation can be broken down into various processes according to the complexity of the system.

Master Plan

This is basically the process of preparing the blueprint for the entire CSV.This process is the pivot of a validation program since it covers the complete setup such as the physical hardware, software, sites and also validates processes such as risk mitigation and redundancy strategies.

Project Plan

This process defines the standard operating procedures for each process in a validation assessment program and is a subset of the master validation plan. More importantly it defines a deadline within which the CSV must be completed.

Installation Qualification

This stage delves deeper into the installation process and creates checks and balances for any new component that may have been purchased(such as new IT equipment) or any new software or hardware that may have been installed.

Operational Qualification

This phase checks the accuracy of the operational functions and the security process (physical security, software security, firewalls etc.).

Performance Qualification

PQ tests specific applications and proactively engages in maintenance and conducts performance tests.

All the processes contribute to effectively meeting pharmaceutical cGMP and help ensure that all the technical systems involved are contributing to help meet the required product quality standards.