Computer System Validation
Our validation specialists understands 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. They can maximize the value of your compliance investment by testing to 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 consultants have vast knowledge of validation requirement in regulated and non-regulated industries. As a part of validation effort, we deliver 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