Another Computer Systems Validation project successfully completed

03 February, 2010

We have just completed another computer systems validation project. In all these projects we use a 2-phase approach. In Phase 1, we review and audit the computer system with respect to:

  • US FDA: 21 CFR Part 820 Medical Devices Quality Systems Requirements
  • US FDA: General Principles of Software Validation; Final Guidance for Industry and Staff
  • US FDA: 21 CFR Part 11 Electronic Records; Electronic Signatures
  • US FDA: Guidance for Industry Part 11,— Scope and Application
  • ISPE: GAMP 5 A Risk Based Approach to GxP Compliant Computerized Systems

We use a risk based approach to assess the computer system and determine the impact to patient safety, data integrity and product quality.

We prepare a report and findings and present this to the customer. We also provide a validation or remediation proposal if needed. This outlines what effort is involved and what the scope of any required work is. This phased approach has proved very popular with our customers. For more information; please contact Velopi

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