UK Computer Systems Validation Services

Based in the North West of the UK, CSVuk provide Computer Systems Validation (CSV) Services to the primary and secondary pharmaceutical industries in the UK and Europe, which are regulated by the Food and Drug Administration (FDA) and the Medicines and Healthcare products Regulatory Agency (MHRA).

We have a proven history of providing high quality, cost effective validation solutions to meet our customer needs in the biotechnology, active pharmaceutical ingredient (API) and medical device industries; with a range of experience through project management, engineering design, risk assessment, and validation (prospective and retrospective).

We frequently undertake assignments to complete prospective and retrospective computer systems validation of manufacturing and laboratory equipment, perform GMP audits of existing computer systems, risk assess new and existing computer systems, and review/enhance CSV policy in line with current regulations and regulatory guidance. We also give added value by managing technical fixes, provide technical detail for inclusion in Operation and Maintenance (O&M) manuals and Standard Operating Procedures (SOPs), and offer technical support to production departments whilst operators are being trained.

Our associations with similar CSV Consultancies and Engineering Services companies in the UK and Europe enables us to provide single consultants and teams of consultants on short-term and long-term assignments at competitive market rates.

Computer Systems Validation Services:

Computer Systems Validation Policy Services:

Engineering Services:

Quality Management System Review:

Equipment and Systems:

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