Validation

Computer Systems Validation

Based on our knowledge of GAMP and Industry Best Practices for Computerised System Validation we provide risk-based validation services for small and large systems alike. We have experience in validating computer systems across the GxP spectrum from Laboratory Information Management systems, Manufacturing Materials Management and Dispensing Systems to Clinical Trial Management, Regulatory Document Management Submissions (CTD / eCTD) and Pharmacovigilance systems as well as infrastructure services including IT Service Desks, Data Centres and Networks.

We can help you in the implementation project management and deliverables production including:

• Validation/Qualification Plans.
• Validation/Qualification Protocols.
• User Requirement Specifications & Requirement Traceability matrices.
• Review and Oversight of Technical Activities/Documentation.
• Test Plans, Specifications and Reports.
• System Validation and User Test Management.
• Validation/Qualification Reports.
• System Administration, Maintenance and Usage SOPs.