Validations

The term validation refers to the activity required to ensure that a product / process / equipment / system meets the pre-defined quality, operation and safety requirements.

A validation process includes planning and execution of testing processes to ensure that the equipment / process met the regulatory requirements, as well as the different definitions of the customer’s requirements.

Validation documentation is part of the validation process, which contains written and / or electronic records regarding installation, operation, and performance of the equipment / system / cleaning / process & shipping.

We at RS NESS believe that validation is one of the most critical activities and is an integral part of the development process. We work according to your project / product and development documentation and in cooperation with your engineers to receive a full and deep understanding of your system, and perform the most thorough and complete validation process.

What do our validation services include?

  • Validation Master Plan writing
  • Writing a Design Qualification document
  • Writing validation protocols for:

               Process
               Equipment and complete production lines
               Critical systems
               Temperature mapping of equipment ,storage and shipping
               Cleaning
               Computerize System Validation (CSV)

  • Execution of  validation
  • Preparing and editing the final reports

A Proper Qualification/Validation process will improve system/ equipment performance and process yields, and will assure that the final product meets all quality and repeat ability requirements defined by the regulator. The validation report is being audited and inspected frequently as part of FDA/ISO/CE quality audits, as it has a direct impact on the final customer and patient’s health.

Validation Life Cycle

Validation Life Cycle