1. Concept

We define the business objectives and goals of the project - milestones with preliminary dates, team organization and the detailed tasks necessary to successfully complete the project. Outputs of this phase include a high-level Project Plan that will provide the foundation of the current implementation and the future design and a Design History File is created to capture the any development and design detail for the product.

2. System Requirements

We produce clear and consistent requirements and provide a common understanding of the products expectations which are captured in a System Requirements Specification. This phase also addresses safety issues by including Preliminary Hazard Analysis as well as a Configuration Management Plan to address release of the software.

3. Functional Specification

We produce specifications to describe how the product or solution will meet System Requirements. A Requirements Traceability Matrix is created which maps each Functional Specification to a single System Requirement. A Detailed Hazard Analysis is performed and specifications which are affected by hazard mitigations are updated as well as updating the Preliminary Hazard Analysis. A System Test Plan is generated to describe verification and validation activities and acceptance criteria for the software.

4. System Design

We create detailed System Design Documents that will be the blueprint of how the system will be constructed to meet the specifications. The technologies will be identified and data items will be defined. The user interface and the data flow diagrams or class diagrams will be approved. Communications protocols may be created to define how the system interfaces with external systems. In addition, test data sets may be defined and described during this phase.

5. Construction

Our engineers start building the software under a process which ensures that a well thought out design does not get lost in the implementation. Verification testing activities such as Unit, Integration, Structure, and Functional testing are executed and documented. We work to demonstrate the software’s consistency, completeness and accuracy at each stage of development. A Requirements Traceability Matrix is created to map each Functional Specification to a test case as well as to ensure there are no breaks in test coverage.

6. Testing and Validation

Testing activities are conducted and documented to make certain that the final product meets the user requirements. We plan validation activities to simulate actual user environments and final validation may be conducted by the customer. At the close of this phase, the customer confirms that the final product meets their needs. As a result of our process, clients have been able to optimize their validation effort by removing parts of verification testing and focus on validating on their product and making it ready for FDA submission.

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Phone & Email:

(919) 367-0003
Fax (919) 367-9966
info@code-refinery.com