Computer system validation (CSV) is a documented process of ensuring that a computerized system does what it is designed to do. Generally, it comprises both computer hardware and computer software. It broadly equates to software validation and qualification, particularly for standard equipment such as PC based systems.
It is essential to appreciate that computer system validation is mainly done for life sciences-related businesses. These include:
- pharmaceutical and biologics manufacturers
- medical device manufacturers
- clinical research organizations
- GLP laboratories
Moreover, most of the industries that seek for CSV are those that are in the FDA regulated fields. They ensure that the systems run by these companies are working in the exact conditions that they are supposed to work. Lest there is a malfunction that can cause adverse effects to those receiving those services.
Now let us look into the two primary functions of CSV;-
Verification
It looks for consistency, completeness, and correctness of the software and its supporting documentation, as it is being developed. Plus, it provides support for a subsequent conclusion that software is validated.
Some of its verification functions include;-
- review and approval of specifications
- formal design reviews
- code walkthroughs
- testing (IQ, OQ, PQ)
- trace matrices
- validation report
- confirmations of training materials, user and tech SOPs, DRPs
Qualification
As defined by IEEE, qualification involves formal testing to demonstrate that the software meets its specified requirements. It dials down to;-
- Design Qualification (DQ) – includes database design, logic/process design, security design, interface design, architecture design, network requirements, and specific peripheral devices.
- Performance qualification (PQ) – Demonstrates the system functions as required in a manner that flows over time and fits the client’s needs
- Operational qualification (OQ) – Shows that all the functional elements of the system work properly and are as per the user requirements
- Installation qualification (IQ) – Demonstrates the system is installed correctly and according to the recommended environmental conditions and that all components are installed in place.
- User Acceptance Test (UAT) – Just as the title suggests, it is usually performed by the user to document user acceptance before the system is launched for operations
Why is Computer System Validation Important?
Now that we have broken down what computer system validation is, it is crucial to understand its significance in the fields.
Over the years of regulation in the different fields of manufacturing and processing, computer system validation has been used in most of these fields. It ensures that the user needs are met and that high-quality products reach consumers.
Some of the fields that have significantly benefited from computer system validation are as follows:
- Medical Device Software – Medical imaging software is one of the services that require validation.
- Production Software – Software that manages manufacturing process such as factory automation and product monitoring or even labelling software
- Quality Management Software – Used in programs intended to ensure quality products
Conclusion
Applications of CSV continue to increase as the business world gradually turns into an automated village. To a greater extent, more requirements are birthed to cater for the new inventions that come up with every rising sun
