Validating IT systems

Home Our areas of expertise Validating IT systems

Sunnikan supports clients through their IT system validation process

Sunnikan incorporates this aspect into all the services it provides. IT system validation can involve training, recommendations, document drafting assistance, carrying out impact assessment reports and helping with validation operations.

Validating IT systems

Sunnikan supports clients through the processes needed to acquire IT system 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

Training

Sunnikan runs training sessions for IT system 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 IT system validation (ISV)
  • 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 IT system validation (ISV) structure:
  • Understanding the principles of ISV
  • Understanding the relevant regulations (BPx, 21 CFR Part 11) and applicable framework documents (GAMP 5, PIC/s)
  • Identifying the components of an ISV quality assurance system
  • Defining ISV 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
  • VSI auditing

 

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