As quality assurance and regulatory affairs (QA/RA) stakeholders know, software used in designing, manufacturing, testing, and servicing of finished devices intended for human use must be validated not only upon initial implementation, but again with each software upgrade that is applied.
Many deliverables and software validation test plans (or protocols) are needed to establish, execute, and document that each version of the QMS software solution works as intended.
Software validation involves:
- Risk assessment
- Documentation and maintenance of software intended uses
- Validation of test cases
- Traceability matrices
- Validation test plans
- Execution records with corresponding objective evidence
- Validation reports
With homegrown or traditional on-premises software, the pains associated with these validation deliverables can quickly exceed a medical device manufacturer’s appetite for enhancements and upgrades. This results in key quality stakeholders opting to avoid upgrading the software or possibly upgrading the software without the necessary validation. If software updates occur without necessary validation, the company risks audit issues that could result in serious penalties or business closure.
“Although the Arena team was not involved in our FDA inspection, your solution helped us find and retrieve records quickly to address inspection requirements ahead of our schedule. Thank you for supporting our needs and creating a solution that really works as promised!”
– Michelle J. Potvin, ASQ CQA, Director, Quality Assurance & Regulatory Affairs, Swan Valley Medical
For traditional on-premises software customers, this creates an unfortunate chain reaction of consequences. When customers choose to ignore multiple important software updates to avoid validation impact, the on-premises solution can no longer be fully leveraged as new features and security improvements are unavailable. Ultimately, quality and product teams become frustrated by the knowledge that they are working harder to make old software fit current needs.