Industry leaders share insights on QMSR Implementation Challenges & Audit Readiness

The RAPS Philadelphia Chapter, in collaboration with West Pharmaceutical Services, convened regulatory, quality, and industry professionals for a dynamic session focused on the implementation of the FDA’s Quality Management System Regulation (QMSR). Held at West’s Exton, PA facility, the evening provided a collaborative forum for industry professionals navigating the transition from the longstanding Quality System Regulation (QSR) to the newly aligned framework modeled on ISO 13485.

Panelists included West and Industry professionals with over 120 years of combined experience working with the FDA in the field of medical devices and/or combination products.

• Dr. Anya Harry, Vice President and Chief Medical Officer, West Pharmaceutical Services

• Fran DeGrazio, President and Principal Consultant, Strategic Parenteral Solutions LLC

• Mindy McCann, Vice President, US Operations and Principal Consultant, QSERVE Group

• Kevin Lentz, Sr Director, Regulatory Affairs, West Pharmaceutical Services

Each panelist brought unique perspectives and expertise to the discussion, which was focused on the following themes:

• FDA Audit Expectations – While the FDA has not yet provided definitive details on the postimplementation audit structure, panelists agreed that inspections will not be significantly different from the audits historically conducted by the FDA. Any changes to the methodology will likely evolve from traditional process specific reviews to a more risk based, holistic approach, similar to ISO 13485 or Medical Device Single Audit Program (MDSAP) audits. As a result, manufacturers should be prepared to clearly show how their quality system processes connect. This includes, but not limited to, demonstration on how internal audits feed into investigations, CAPAs, training, and other oversight mechanisms.

  In addition, documents such as management review records and internal audit reports are now explicitly within FDA’s scope. This raised concerns among industry that FDA could issue observations for issues already identified internally, reported through management review, and currently under remediation. The panel acknowledged this possibility but emphasized the importance of full transparency—demonstrating what was found, how it was escalated, and what corrective actions are underway.

  Ultimately, a well functioning quality management system should continually identify and correct issues. By providing transparent information with appropriate context, manufacturers can reinforce to the FDA that their systems are effective, responsive, and operating as intended.

• Holistic Risk Management Integration - A recurring theme throughout the discussion was the persistent gap between maintaining formal risk management files and truly operationalizing risk-based thinking across all quality system processes. Although risk management is not new, panelists noted that many organizations historically maintained ISO 14971compliant files that were rarely revisited after commercialization, resulting in limited evidence to FDA that risk meaningfully informs decisions in areas such as CAPA, change control, complaints, and supplier oversight.

  Under QMSR, manufacturers will be expected to integrate risk considerations into every process, decision, and action, creating clear linkages across the quality system. This represents a shift from evaluating risk in isolation within a single process to understanding how risks extend upstream and downstream, influencing interconnected activities throughout the product lifecycle.

  Specific to suppliers, the panel emphasized that aligning expectations around processes, systems, and risk management is critical—and the Quality Agreement is a key mechanism for achieving this. FDA expects manufacturers to ensure their suppliers maintain compliance, making proactive, continuous alignment essential. By setting clear expectations and embedding riskbased requirements within supplier relationships, manufacturers can help ensure compliance is consistently maintained and demonstrably integrated across the supply chain.

• Building and Demonstrating a Culture of Quality - The panel also explored how organizations can demonstrate a genuine culture of quality. There is an expectation that extends not only across the QMSR but throughout all regulatory frameworks. Panelists emphasized that, much like risk management, a culture of quality is not defined by a checklist or set of discrete activities. Instead, it reflects a holistic, organization wide commitment to quality, spanning from the manufacturing floor to the Csuite.

  They also highlighted the importance of anchoring this culture in the higher purpose shared across the medical device and pharmaceutical sectors: improving patients’ lives. When patients are placed at the center of daily work, team members can better appreciate the significance of their roles and how their actions directly influence product quality and patient outcomes.

  Ultimately, the panel noted, a “culture of quality” is something auditors expect to see lived, demonstrated, and embedded—not merely documented on paper.

The session underscored not just the operational and audit readiness implications of QMSR, but also the broader purpose behind regulatory quality systems. Effective implementation of QMSR, alongside all other regulatory requirements, strengthens the foundation of product quality, risk management, organizational accountability, and lifecycle oversight.

Ultimately, comprehensive regulatory compliance is not merely a requirement, it is a commitment to patient safety. By embedding risk-based thinking, fostering a genuine culture of quality, and maintaining transparent and effective processes, manufacturers help ensure that every product reaching a patient is safe, reliable, and of the highest quality.