Digitization Of Validation For Effective Off-Site Regulatory “Review” and “Inspection”

Conclusion: The current paper-based on-site inspections present challenges to the efficient and effective utilization of FDA and industry resources for verification and enhancement of quality and compliance. Travel restrictions presented by COVID-19 further exacerbate the challenges of continuing the current construct. Digitally enabled remote inspections would reduce administrative burden, allowing both the agency and inspected entities to focus more effort on addressing gaps, continuous improvement, and implementation of best practices. Standardized output and communications would reduce time to understand opportunities, set action plans, and implement improvements that provide benefits to FDA, inspected entities, and enhanced quality and safety to patients.

In and beyond the COVID -19 pandemic, the need for a transparent method of evaluating and communicating quality management maturity is acute and critical (5). Using technological solutions, manufacturers can demonstrate the rigorous oversight of their systems. Their supervision should demonstrate understanding and control over their manufacturing processes. When regulators such as the FDA can observe the rigor and maturity of a corporate QMS, they can exercise a more flexible regulatory approach. Such a flexible approach should create opportunities that are genuinely aligned with the notion of partners in public health, reduce the need for “extensive regulatory oversight,” and encourage continual improvement of manufacturing processes. One can expect that a formal rating system to measure and rate quality management maturity will need to emerge soon. Now is the time that firms seriously consider investing in technologies that contribute to maturity and oversight of their QMS and enable drawing a distinction from others with less mature systems.

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