Computer System Validation

Computer System validation at Cispact ensures the reliability, accuracy and consistency in computer performance and the integrity of electronic records. Our highly qualified and experienced consultants have real-world domain experience, the right capabilities and required tools that tackles all types of applications/systems used in the healthcare sector. To ensure patient safety, data integrity and product quality, we provide validation services which are cost-effective and efficient in GXP environments. Not just that, we have also championed our way into producing timely results that meet its predetermined specification and quality attributes as per various regulatory bodies.

Computer System Validation Services

  • Planning, execution and documentation of IQ, OQ and PQ
  • Monitoring of system inventory, user requirements and functional requirements.
  • Planning, assessment and traceability of system validation
  • Complying each deliverable with the GAMP 5 standards.
  • Initiating coherent validation strategy along with QA, IT teams for regulatory quality requirements
  • Incorporating standard templates, SOPs, tools, reusable assets, for cost-effective & timely results.
  • Assisting through the authoring and reviewing of SOPs, templates, checklists as per GAMP 5 standards.
  • Creating, managing & delivering all validation reports and final release documentations

” We avoid cryptic test scripts and third party vendors to ensure a risk-free and validated computer system through all stages of trials. “