Software Development Life Cycle Policy – Manufacturing Software Validation

Looking at the life cycle policy for software development, the FDA considers software validation to be “confirmation by examination and provision of objective evidence that software specifications conform to user needs and intended uses, and that the particular requirements implemented through software can be consistently fulfilled.”  The the software development life cycle process ensures that this provision is met during the stages when the software is designed and the programs are written.

This activity is iterative in nature. Whether the software development constitutes the entire project or is part of a system (hardware and software), software requirements should be generated from business requirements and user requirements.  The Business Requirements describe the baseline for the system concept of the application. The User Requirement Specifications (URS) will be the baseline for the functional requirements of the system.

The Functional Specification (FS) document is the starting point of software development and the basis of the Detailed Design Specification (DDS). The purpose of the FS document is to define how the system will meet the URS. It defines the required functionality from a technical and system engineering perspective, the business processes and software and system processes to be supported, the data and information on which the software to be designed will operate, and the system environment it will operate within. Each FS requirement should be individually identified and documented and should be verifiable during operational qualification testing.

Testing the medical device manufacturing software during the development life cycle typically includes showing that all detailed design specifications have been implemented properly and each one can be traced to a functional requirement.  Unit testing and other verification activities are done at each stage of development and culminates in factory acceptance testing at the end of the cycle.

InstantGMP™ MD is a medical device manufacturing software system that was designed using Business Requirements Specifications. The software is a full-scope integrated manufacturing system that streams the entire manufacturing process including inventory control, material management, specification control, and electronic batch records. Overall, the software simplifies documentation and approval procedures, increases production efficiency, and provides a centralized system for manufacturing documentation. Furthermore, quality assurance procedures were written simultaneously during InstantGMP™ MD development in order to maximize quality, reduce errors, and ensure GMP compliance.

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