Computerized Systems Validation (CSV)

Sunnikan supports clients through the processes needed to acquire Computerized Systems Validation in compliance with Good Clinical Practices GAMP 5, 21 CFR Part 11:

• Training sessions
• Consultancy
• Defining validation strategies
• Drawing up validation procedures
• Drawing up validation process documentation
• Carrying out tests
• Change control systems
• Audits

Sunnikan runs training sessions for Computerized Systems Validation. This training is provided:

• as inter-company workshops
• or in-house workshops: tailor-designed training plan, with training provided on the client's premises

Training goals

• Equipping trainees with an understanding of the principles underpinning Computerized Systems Validation (CSV)
• Acquiring the knowledge needed to develop and implement a streamlined ISV process in the context of clinical research operational systems

Example training programme

• Setting up an Computerized Systems Validation (CSV) structure:
• Understanding the principles of CSV
• Understanding the relevant regulations (BPx, 21 CFR Part 11) and applicable framework documents (GAMP 5, PIC/s)
• Identifying the components of an CSV quality assurance system
• Defining CSV roles and responsibilities
• Knowing how to roll out validation processes
• Identifying and implementing key steps in the validation process applicable to operational systems: Data Management, Statistical Analysis
• Knowing how to prepare a validation case file: Specifications, risk assessment, validation protocol, test protocol, test files, test report, validation report, validation certification
• CSV auditing