Computer System Validation

Pharmaceutical and biotechnology computerised systems validation

The integrity of computerised systems is critical within the pharmaceutical, biotechnology and life sciences industries due to the potential impact on patient safety, product quality and data integrity.

Computerised Systems Validation (CSV) is a structured process designed to mitigate these risks by ensuring that a system meets applicable regulatory requirements, is fit for purpose and functions as intended.

At Scitech, we have extensive experience supporting pharmaceutical and biotechnology manufacturers, clinical research organisations, and laboratories with the design, implementation and validation of new computerised systems; ongoing activities associated with operational computerised systems, including change management and periodic compliance reviews; and retrospective activities bringing pre-existing systems into compliance.

We can assist with the full project life cycle, from understanding and documenting user requirements and writing project validation plans through to auditing suppliers, writing or reviewing design documentation, writing and executing test plans and protocols, and writing policies and procedures on computerised systems validation and data integrity. We use the GAMP 5 guide as a basis for many of our document templates and processes, risk management for example.

Our pragmatic, risk-based approach to all projects will ensure that we only undertake the activities that will add value; and our detailed understanding of the regulatory landscape will ensure that your computer systems are compliant with all of the applicable regulatory requirements (FDA, MHRA, EMA) providing you with the confidence that your computerised systems operate to the applicable GxP standards.

We have experience performing these activities on a wide variety of computerised systems, including:

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