Computer Validation

CSV (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.

A validation assessment program is a necessity in the pharma industry to ensure adherence to pharmaceutical cGMP guidelines, and to help companies maintain consistent quality. The same principles are applied in computer system validation to a computer system or an information technology system.

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 Needed for Computer System Validation

CSV is dependent on the complexity of the project and can be largely broken down into the following processes:

* Master Plan

This checks whether the specifications are in line with user requirements. During this stage, teams are also established which will run the entire process. The set of activities to be carried out during validation are established too. 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.

A detailed documentation and training on the standard operating procedures (SOPs) is carried out during this process. Additionally activities such as risk assessment, backup planning and change management are also undertaken during this phase. If a master plan is defining the outline, then a project plan is the execution stage.

* Installation Qualification (IQ)

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 (OQ)

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

Note: IQ and OQ are usually conducted in tandem with each other for all technical systems and also to check how much the system created is in line with user requirements and specifications.

* Performance/Process Qualification (PQ)

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.

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