Computer System Validation

COMPUTER SYSTEM VALIDATION

Arithmos team has extensive experience in validating systems in the healthcare sector. To ensure patient safety and full adherence to regulatory requirements, we provide validation services for our products in a cost-effective, efficient and fully compliant manner for both the GVP and GCP environment.

We follow a CSV pragmatic approach that has 2 main objectives
Guarantee the implementation and development of computer systems in line with customer requests using best practices with a minimal number of defects;
Produce the necessary documentation to ensure system compliance in accordance with international pharmaceutical standards (particularly 21 CFR part 11 and Annex 11).

Arithmos Validation approach and best practices

  • Risk Based Approach
  • Prospective Validation
  • Usage of International Standards (GAMP 5) and Internal QMS
  • Usage of templates and validation scripts
  • Monitoring and control over the project:
    –   Quality review checkpoints
    –   Quality acceptance criteria
  • Multidisciplinary project team covering all validation aspects (Business Analysts, IT experts, CSV& QA specialists)

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