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Computer System Validation

Our validation specialists understand and are trained on regulations set forth by authorities like FDA, WHO, CFDA, Health Canada, etc. for laboratory informatics systems, instrument systems, and computing environment validation. This will help in maximizing the value of your compliance investment by testing the level of risk and cost of the risk to the organization. In other words, some requirements will require a more thorough test to ensure that the system meets the requirement and our consultants are skilled at recommending the appropriate level of testing required for each module based on the risk category.

Our validation specialists have a thorough understanding of the implementation of validation requirements in regulated and non-regulated industries. As a part of computer systems validation and allied validation services, we offer the following services:

  • Business Process Maps
  • Requirements document (User, Functional and Design requirements)
  • Validation Plan
  • Risk Assessment Report
  • Developing Unit Testing Form (UTF)
  • Dry run of UTF
  • Validation Scripts
  • Execution of Validation Scripts. (IQ, OQ, PQ)
  • Traceability Matrix
  • Standard Operating Procedure, Work Instructions, or User Manuals.
  • Corrective/Preventive Actions
computer system validation