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  • Speciality and Fine Chemicals

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Computer System Validation (CSV)

Computer system validation (sometimes called computer validation or CSV) is the process of documenting that a computer system meets a set of defined system requirements.

Validation of computer systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records is a critical requirement of electronic record compliance, as described in the FDA 21 PART CFR 11.

Our computer system validation experts validate computer programs for all types of FDA-regulated businesses and pharmaceutical facilities, including biologics manufacturers, medical device manufacturers, clinical research organizations, and GLP laboratories.

  • Computer systems validation services for Pharma business and laboratory data management system.
  • Compliance with 21 PART CFR 11.
  • Databases made compliant with Indian FDA requirements & other regulatory.

Computer validation is more than a compliance requirement. Pharmaceutical computer system validation is a unique opportunity to examine their computer systems to maximize effectiveness and enhance quality.

Our Systems ensures that your validation project clearly documents why your customers should share the high degree of confidence you hold in your company and your systems, while scaling the project to your organizational validation requirements and budget.