Verification / Validation

The concepts of system verification, validation and qualification are not new; however, more and more companies are recognizing the importance of undertaking these steps to prove the critical aspects of their particular systems.

With our in-depth knowledge of the regulatory process, we customize our approach to match your specific application requirements and the relative risk of the software involved. Code Refinery tests products that are regulated in order to validate the final product with respect to end-user requirements. We work to demonstrate the software’s consistency, completeness and accuracy at each stage of the development life cycle, assuring safety and effectiveness and improving process efficiency to meet FDA regulations.

Verification

The goals of verification are two-fold: 1) to confirm by examination and objective evidence that a software requirement has been satisfied, and 2) to confirm that outputs from a development phase meet all of the input requirements for a subsequent phase. Our verification activities consist of, but are not limited to:

- Code Reviews
- Unit Testing
- Integration Testing

Validation

The goal of Code Refinery’s validation phase is to establish thorough objective evidence that the software conforms with the user needs and intended use of the system. Our validation process consists of planning and specifying how the software, instrumentation and ancillary systems will be tested to show that each requirement has been satisfied.

Installation Qualification (IQ) establishes confidence that the system is compliant with appropriate codes and approved design intentions and that manufacturer’s recommendations are suitably considered.

Operational Qualification (OQ) is done to ensure that the system is capable of consistently operating within the set limits and tolerances.

Performance Qualification (PQ) establishes, through appropriate performance tests and related documentation, that a system consistently produces a product meeting all pre-determined requirements for functionality and safety.