Whenever a software/system is built or planned for development, software validation is an integral part to be looked upon. Organizations should basically validate their products as per the regulations such as 21 CFR Part 11 Software Validation, 21 CFR 820 Software Validation, and GAMP 5 Computer System Validation.

With an expert in-house compliance team, we support firms to perform Software Verification and Validation, Computer System Validation (CSV), Pharma Software Validation, Pharma Computer System Validation, and periodical Process and Product Validation. We establish documental evidence throughout the lifecycle. RAAJ GPRAC works hand-in-hand with clients from a concept to software to ensure clients’ products meet necessary Regulatory requirements.

  • Software verification and validation as per CSV, 21CFR Parts
  • Validations Services (i.e., Analytical Method Validation, Process Validation, Computer System Validation - CSV as per EU Annexure-11, GAMP-5, 21 CFR parts11)
  • Retrospective Validation for Existing Systems
  • Analysing Gaps in Existing Documentation
  • Expert Validation Support to Fill the Gaps
  • Validation Certificate
  • Validation & Qualification of Pharmaceutical Manufacturing equipment & Laboratory Instruments [DQ, IQ, OQ, PQ] with complete validation documentation.
  • Progressive Software Validation as per Health Authority Guidelines