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Computer System Validation

Nanda Technologies has become a recognized leader in providing a variety of compliance services to the Life Sciences/Pharmaceutical/Biotech Industry. As a full-service company we have been helping life science companies become compliant with IT-related regulations and guidelines. We help our clients improve the level of compliance while reducing their compliance costs.

Nanda Technologies has been working with regulated industries for many years now, giving us a unique perspective and an understanding of what it takes for any size company to be in compliance with FDA and other governmental regulatory agencies. We have demonstrated expertise in the following areas:

  • Computer Systems Validation - CSV

  • 21 CFR 11 - Electronic Records / Signatures

  • Validation of applications (requirements, traceability, protocols, scripts, summary reports)

  • Localized regulatory compliance assessments and remediation

  • Infrastructure qualification

  • CSV project management

  • Coaching CSV projects as compliance experts

  • Training on CSV, Part 11, Auditing, and Testing

  • Retrospective evaluation/validation of legacy systems

  • System testing

  • Supplier audits

  • SOP development.

  • Clinical Adverse Event Systems / Data Mgmt. and Safety / CAPA Systems

  • Manufacturing Equipment Qualification and Process Systems (C&Q)

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