Computer System Validation (CSV)

Our highly experienced team delivers compliant and practical Computer System Validation (CSV) services in line with Eudralex Volume 4, Annex 11, 21 CFR Part11 and GAMP® 5 2nd edition.

This includes:

  • Performing gap assessments of existing systems, processes and procedures

  • Developing and/or updating CSV and Data Integrity (DI) policies and procedures

  • Reviewing or writing validation documents

  • Performing lifecycle reviews

  • CSV execution

  • CSV project support

  • Vendor selection and qualification, including performing audits

  • Providing bespoke CSV education and coaching to develop in-house capability

  • Performing life cycle assessment/reviews

  • Performing DI risk assessments and closing associated actions

Computer System Validation
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