Computer System Validation

CSV is a methodology applying to computerized solutions in highly regulated industries like pharmaceutical and medical devices.

• Are the specifications in line with the user requirements?

• Have you defined standard operating procedures?

• Do you have a solid understanding of your installation process?

• Are your operational functions accurate and secure?

• Are you performing performance tests on specific applications?

Computer System Validation ensures your computer systems are implemented and used according to GMP guidelines. In industries such as the Pharmaceutical Industry validation is a necessity. Adherence to pharmaceutical GMP guidelines helps companies maintain consistent quality and reliability for their electronic record keeping.

Dynetek can help you achieve Computer System Validation based on GMP & GAMP guidelines.

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  • Fast track administrative approval.

  • Maximize the value of the system and the employees that use it.

  • Discover system defects early.

  • Reduces risk and legal liability

  • Promote continual process improvement.

Software & Computer Systems

Successfully pass regulatory inspections.