Vani Consulting's validation engineers will help ensure that your processes and systems are developed and qualified following a structured life cycle approach consistent with the Industry Regulations like, FDA, ISO, OSHA, etc.

We have developed a structured life cycle approach combining best in class processes and a suite of services designed to ensure that you are in compliance with the applicable sections of the cGMP/GLP/GCP, 21 CFR Part 11, Part 820, ISO 13485, and ISO 14001.


This structured approach can be used for validation of a manufacturing process, equipment or a computerized system. The approach includes the following steps customized to your unique needs:

  • Supplier/Vendor Audits
  • RFP/RFQ Process
  • Client Validation Life Cycle Process Implementation/Audit
  • 21 CFR Part 11 Audits/Remediation Plans
  • Policies & Procedures Development
  • Validation Plans
  • Disaster Recovery Plans
  • Operation & Security SOPs
  • Change Management and Control
  • User Requirements and Design Documents
  • Protocols, Test Plans, Test Scripts
  • End User Training


OUR SERVICES INCLUDE :

  • Providing Recommendations For Validation (like a roadmap to successful validation)
  • Validation that meets the requirements of current industry standards
  • Process Gap analysis and application assessments, Writing SOPs for compliance with regulations
  • Post Validation Support & End User Training​



Validation