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Quality Assurance Program
Gale Force Software Corporation (GFSC) uses a well-defined development process that is outlined by our internal quality management system in the execution of projects for our clients. This development process is aligned with the FDA Quality System Regulation (21 CFR 820) and the ISO13485 standard for the development of medical devices. This development process consists of the following phases: (1) Planning, (2) Design Input, (3) Design Output, (4) Design Verification and Validation, (5) Design Reviews. Our development process has been successfully audited by our medical device customers and all members of the GFSC staff are trained on its usage.
During the Planning phase a risk management plan is created that captures potential project risks that can affect the overall successful completion of the project and the product quality. These risks can identify resource risks, process risks, technology risks and even product feature risks. The intent of the risk management plan is to identify risks so that appropriate mitigations can be put in place to minimize or eliminate these risks. Mitigations may include additional design reviews, increased testing, or independent quality audits.
The Design Review phase is listed last but is in actuality a phase that runs in parallel with the other phases. Design reviews are a critical component for monitoring the progress of a project and for helping ensure the overall quality of the product. During design reviews the project team reviews the materials for correctness, completeness, and the appropriateness of the solution. These reviews provide an environment for team members to discuss and question the material being reviewed. When necessary, design reviews will include the participation of quality assurance as an independent reviewer as well as the customer.
The Design Verification and Validation phase is listed as the fourth phase but in actuality it runs in parallel with the third Design Output phase. Design verification and validation is the testing phase of the project. This phase is extremely critical for helping ensure the overall quality of the product and demonstrates the readiness for the product to be released. Since this phase is performed in parallel with the implementation phase, the development of preliminary test protocols results in the early detection of problems that in turn can be corrected earlier in the development cycle. Problems or defects found during testing are captured and tracked via a defect tracking system. The presence of critical defects will prevent the release of a product.
GFSC mainly measures quality by the satisfaction of our customers with the execution and completion of the project. If GFSC fails to deliver a quality product on time and on budget our customers will be dissatisfied. Additionally, quality is determined by the successful introduction of the product by our customers into the marketplace and their continued use of GFSC for post-launch support.
If quality problems are encountered, they are formally documented via a correction and preventative action request. Corrective actions are logged, investigated, and tracked via Quality Assurance. If the investigation of a corrective action results in the need to make a process change, the quality procedure documenting the process will be updated accordingly.
The standards and practices used by GFSC in designing, implementing, and testing software systems results in software applications and products that are built in a way that meet the following goals and characteristics:
- Are stable, reliable, executable products
- Produce the correct results
- Meet or exceed the customer's needs and expectations
- Provide a sound engineering solution to a government or business problem
- Are highly maintainable bodies of source code
- Are well-documented at the system, code, and operational environment levels
- Produce a verifiable product