The Software Development Plan is the planning document for the development of software and software support for a product. It provides an overview of software development, describes how the project is managed, how work is conducted, and how the development process is tailored to meet applicable standards, requirements, and objectives. This includes a description of major tasks and milestones.

The software development plan describes the methodologies employed to document that the approach for refactoring and re-engineering had the desired effect of resolving known limitations and applying extensive enhancements for the product. It also includes verification that the product operates as intended and is maintainable to ensure quality at all milestones and in the final release.

The software development plan should include various procedures from the product’s manufacturer in which will coordinate the software and system development, optimizing the system’s integration, verification and validation. Included in the plan should be sub-plans outlining the way in which software integration, testing, and documentation will be performed and utilized. Various activities will need to be defined to complete a sub-plan for configuration management, including a procedure for identifying defects and appropriately documenting the evidence that determines the defect is not an unacceptable risk.

A software requirements analysis should also be included, describing the system’s security and protection. Control measures should be instituted as it relates to risk, for example, defects and failures as it relates to software and hardware. Within the software development plan, update and verify the system’s requirements, ensuring the requirement criteria is on track to be, or has been, met. Still focusing on risk, identify risk controls for the software’s architectural design, as well as the way in which it will be verified. Create a detailed design for all parts/units of the software, including a design and verification plan for the interface.

Implementation will also need to be planned in this document. Create a software implementation and verification process in which the product manufacturer must consider all strategies, methods, and procedures necessary to complete testing. Additionally, consider acceptance criteria and testing for the software. A separate integration plan must be created to ensure the product manufacturer properly integrates and verifies the software. Subsequent testing must be completed to provide evidence of a successful integration. Upon completion of the integration testing, the test procedures must be evaluated for accuracy.

Testing will need to be completed for each software requirement, as well as verification of the testing procedures. Best practices include creating a software problem resolution process, as well as retesting after any changes are made. The software system tests must be verified and evaluated, ensuring the tests can be repeated with ease. The standards for IEC 62304 require:

1. a reference to test case procedures showing required actions and expected results;
2. test results identified as pass or fail and any irregularities
3. a list of all the software versions that were tested
4. all test configurations as it relates to hardware and software
5. any/all tools utilized during testing
6. testing date
7. identification of the person performing and recording the tests

Finally, a software release procedure/plan must be created to verify that all activities have been performed as specified, for example, verification and testing. Every testing outcome should be documented as well as all software versions that have been released. After everything is appropriately documented, the software must be archived and delivered.

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