Engineering in Ellesmere Port Directory

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CSV UK Ltd
Ellesmere Port, Cheshire, CH66 1TD
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.
CSV Specialist Validation Regulatory Compliance Engineering Consultancy Computer Systems Validation
Asset Inspection and Material Services
Ellesmere Port, Cheshire, CH65 4HF
Inspection and material science service to refinery and petrochemical sites.
Asset Inspection and Materials Services
Ellesmere Port, Cheshire, CH65 4HF
On site inspection of tanks, vessels, pipework etc. Materials science laboratories including scanning electron microscope.
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