CSVuk provide Computer Systems Validation Services to the primary and secondary pharmaceutical industries in the UK and Europe, which are regulated by authorities such as the Food and Drug Administration and the Medicines and Healthcare products Regulatory Agency.
CSVuk have experience of computer systems validation (CSV) throughout the pharmaceutical industry, including primary and secondary biotechnology, sterile manufacturing, API, and medical device manufacturing facilities. Validation experience includes ERP, BMS, FMS, DCS and PLC/SCADA systems, fermenters, centrifuges, driers, micronisers, packaging lines, filling and assembly machines, autoclaves, freeze driers, and automated test robots.
Business systems validated include software, spreadsheets, ERP and network infrastructures.
Auditing experience includes Contract Manufacturing Organisations and automation integrator suppliers.
Specialities include defining Computer Systems Validation policy, performing Functional Risk Assessments (risk based prioritisation of validation activities), User Requirements Specification (URS), Functional Specification (FS) and Requirements Traceability Matrix (RTM); Supplier assessment/audit and selection; Automation lifecycle activities: QP, Source Code Review, Test Plan, FAT, SAT, and Commissioning; Validation Master Plans, Validation Plans and Reports; Gap Analysis reports; ERES assessments; Qualification protocols and reports: DQ, IQ, OQ, PQ; Standard Operating Procedures.