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:- Requirements Traceability and Analysis
- Unit Testing
- Structure and Integration Testing
- Functional Testing
- Code Review and Analysis
- Structure and 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.
While the customer has the ultimate say on what validation activities are performed, the default approach used by Code Refinery is to perform a design validation with traceability back to a customer supplied Product Requirements Document and/or a System Requirements Document with additional traceability to Hazard Analysis mitigations. For complex systems, the design validation is followed by the Installation and Operational Qualification Protocols. The IQ and OQ protocols are written to test a specific installation of a system or device at the end user’s location. A performance qualification (PQ) would typically follow the IQ and OQ but would be typically performed by the customer or with assistance by Code Refinery if desired by our client.
Services
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FDA Compliance
- Code Refinery's expertise in FDA compliance for software...
Custom Software
- At Code Refinery, we place great emphasis on clearly understanding your problem...
Verification and Validation
- The concepts of system verification, validation and qualification are not new; however, ...
Development Process
- See how we evaluate and address the most intricate challenges...
