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Validation Services

 


Companies and Organizations that fall under the auspices of the FDA, SEC, FERC or any of the host of other Governmental agencies all have unique requirements for the validation and verification of their computerized systems.

These requirements are put in place to ensure that system that perform critical functions are actually performing the function that they were designed to do or as CMM states it: Verification confirms that work products properly reflect the requirements specified for them. In other words, verification ensures that ‘you built it right‘. Validation confirms that the product, as provided, will fulfill its intended use. In other words, validation ensures that ‘you built the right thing’.


Consortio’s experience spans many industries and regulations. Our validation group can help you with all aspects of Computer Systems Validation including:

  • Validation planning
  • System assessments
  • Gap analysis
  • Risk assessment
  • Protocol authoring
  • Test Scripts (IQ/OQ/PQ)
  • Configuration management
  • Test management
  • Training

To address your computer system validation concerns in a cost-effective, efficient and compliant manner requires a flexible scalable delivery model. Consortio’s proven methodology and services will ensure your system meets tough regulatory standards.

 
 
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