System Validation

System Validation is the process of ensuring that the industrial technology (hardware and software) components controlling the manufacturing plant are in conformance with regulatory requirements overseeing that industry. This conformance is critical because it provides assurance that the manufacturing system and its processes are functional, secure and repeatable with consistent quality.

Our operation and involvement in the healthcare, food & beverage and medical device manufacturing industries requires IS engineers and management to be in constant alignment with FDA/GxP procedures and guidelines. Our I&C experience from the plant floor to the control room, coupled with our years of validation development and execution experience make us a natural partner for our customers.   IS can support requirements from investigation and analysis stage to the implementation of the full suite of validation documentation. System Validations are documented procedures and processes to prove the manufacturing processes are safe, repeatable, reproducible throughout the life-cycle of the system and generates accurate data.  Our validation experience covers from project inception through commissioning and start-up.  We can support new applications or legacy systems that have perceived compliance concerns.  Our team is capable of providing a full system validation strategy as well as all of the associated documentation (URS, SRS, SDS, CSV, IQ, etc.). Our services are summarized as follows:

  • Provide system assessments, qualification, validation and re-validation services
  • Document systems proper design, functionality and potential vulnerabilities
  • Design, develop & execute system validation documentation
  • Employ Change Control and Regression Testing to validation software and hardware alterations
  • Integrate client documentation and procedures with validation requirements
  • Publish clear, precise system validation protocols and reports for systems
  • Utilize our vast controls system knowledge to identify and correct system shortcomings or defects