A Regulatory Affair

In the medical device industry, ensuring devices are safe for use is critical. Placing an unsafe device on the market can have life-threatening consequences. However, many manufacturers struggle to keep up with the continuous flow of regulatory requirements imposed on the industry.

A multinational manufacturer of optical health devices was using several software tools as part of its quality management system, including customer relationship management (CRM) systems and customized spreadsheets. These tools lacked formal evidence demonstrating compliance with FDA regulations, raising concerns about whether the company could continue using them effectively.

The manufacturer did not have the internal capacity to carry out the required validation activities, creating a need for external expertise to ensure their systems could be formally certified for safe and effective use.

Critical Software was engaged to define a software validation strategy for the manufacturer. Given the static nature of the software requiring validation, a manual testing approach was deemed most appropriate and selected for the project.

Test case specifications were defined at the outset. This involved identifying initial environmental conditions, user actions, and expected outcomes to ensure successful certification.

All activities were conducted in accordance with the FDA’s CFR Part 820 regulations (Quality System Regulation), a fundamental requirement for quality management systems in the medical device industry.

Test procedures were then developed, outlining how the test cases would be executed throughout the project. This was followed by test execution, ultimately leading to the generation and compilation of certification documentation.

Critical Software’s work enabled full certification of the software tools used by the organization.

The validation process also uncovered a number of broader issues within the quality management system that, if left unresolved, would have prevented certification. Critical Software recommended several improvements to address these gaps, including expanding the scope of testing to enable faster and more efficient validation without compromising quality.

• SAP-based tools

• Salesforce

• Customized Microsoft Excel templates

• Test case specifications

• Test procedures and reporting

• Documentation aligned with FDA standards