Validating software requirements
Achieving compliance will also include software maintenance and configuration management strategies from the beginning of the software lifecycle until its end.
Last year, 79% of all software related FDA recalls were caused by software defects that were introduced to the system during changes made to the software after its initial production and distribution.
The evaluation process should be documented, and the results should be tied to actions.
Often, when we work with our clients through this process, we utilize a Gap Analysis model and prioritize the highest-risk items first.
We help our clients to determine the appropriate classification for their software and the least-burdensome verification and validation strategy, all based on risk.
The next step in your software lifecycle assessment is a review of the software system architecture and software design rationale.
Such software applications shall be validated prior to initial use and, as appropriate, after changes to such software or its application.
Our team includes Medical Device software consultants, former ISO 13416/MDSAP auditors, and quality experts, all available to help get your quality system up to speed.If you decide to use a Gap Analysis during software evaluation, we recommend starting with a requirement review, which includes a user, system, and software level analysis.Requirement management serves as the foundation for software development and use within the quality system.Medical Device expert specializing in development of efficient Quality Systems for small and startup medical device companies. Rose works as a the contract Quality Manager for multiple medical device companies overseeing overall quality strategy and ensuring compliance through documentation and auditing services. Rose is a certified quality auditor (CQA) and has regulatory and submission experience for a variety of markets including FDA, CE Mark, Health Canada, and CFDA. Rose encourages the simplification of Quality Systems to reduce the quality burden and improve compliance through training and efficient QMS design.At Minitab, we conduct extensive internal testing to maintain the highest quality of our software products.