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CSV Services
CSV Policy Services
Engineering Services
QMS Review
Equipment & Systems |
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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:
- CSV Site Validation Master Plans and Summary Reports.
- Validation Plans and Summary Reports.
- Validation Gap Analysis Reports.
- Validation Position Papers.
- High level risk assessment of Computer Systems.
- Management of Computer Systems Inventories.
- Categorisation of hardware and software according to GAMP 5.
- Electronic Record; Electronic Signature assessments, remediation plans, protocols and reports.
- 21 CFR part 11 interpretation.
- High level Risk Assessments (for prioritisation of validation activities).
- Functional Risk Assessment of systems (providing rationale for content of validation protocols).
- Design Qualification (DQ) protocols.
- Installation Qualification (IQ) protocols.
- Operational Qualification (OQ) protocols.
- Performance Qualification (PQ) protocols.
- Validation Execution and Reporting.
- Equipment Qualification (combined IQ/OQ) protocols and reports.
Computer Systems Validation Policy Services:
- Computer Systems Validation site policy procedures.
- Computer Systems Validation Gap Analysis Reports.
- Computer Systems Inventory management procedures.
- Risk Assessment procedures.
- Configuration Management procedures.
- Backup, Restoration and electronic housekeeping procedures.
- Security Access procedures.
- Disaster Recovey procedures.
- Time synchronisation procedures.
- Control of Suppliers procedures.
- Network management procedures.
- Computer Systems Validation training packages.
- Record retention policies.
Engineering Services:
- User Requirements Specification (URS) generation.
- Functional
Specification (FS) generation.
- Requirements Traceability Matrix (RTM) generation.
- GMP review and Impact Analysis of equipment and processes.
- Design Reviews.
- Installation and Commissioning specification generation.
- Equipment maintenance methods for SOPs.
- Computer System operation and administration methods for SOPs.
- Configuration Management of site Computer Systems.
- Change Control of site Computer Systems.
- Backup/archive strategy of site Computer Systems.
- User, Maintenance, and Administrator level Training on site Computer Systems.
- Security/Access control of site Computer Systems.
- Lockdown of standalone PC systems.
- Programming Microsoft Excel VBA macros for computer systems validation of spreadsheets.
- Retrospective technical specification/system overview generation.
- Alarm Management.
Quality Management System Review:
- Supplier Assessments/Audits.
- Configuration Management.
- Code Reviews.
- Design Reviews.
- Software design tracking.
- Change Control Management.
- Software testing.
- Hardware testing.
- Security of Data and Systems.
Equipment and Systems:
- Freeze Driers.
- Autoclaves.
- Automated packaging and overprinting systems.
- Automated filling and assembly machines.
- Automated sterilizers, vial washers, sterilizing tunnels.
- Packaging Vision Systems.
- Automated Test Robots (medical devices).
- Laboratory Equipment.
- Supervisory, Control and Data Aquisition (SCADA) systems.
- Distributed Control Systems (DCS).
- Programmable Logic Controller (PLC) systems.
- Pure Steam generation systems.
- Water For Injection (WFI) systems.
- Laboratory calculation spreadsheets.
- Batch control systems.
- Continuous control systems.
- Building Management Systems (BMS) including Heating, Ventilation and Air Conditioning (HVAC) Systems.
Contact details:
CSV UK Limited,
8. Woodacre Grove,
Ellesmere Port,
Cheshire,
UK.
CH66 1TD
tel: 07769665695
fax: 01513573616
email:
CSVuk Terms and Conditions of Business can be downloaded in PDF format for your information.
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