Evidence Hub

Quality decisions in regulated environments must be defensible, traceable, and repeatable.
The Evidence Hub presents representative engagements that illustrate how ENQUAL supports medical device, combination product, and biopharmaceutical organizations in making inspection-ready quality decisions across the product lifecycle.

Each case study reflects real-world Quality Engineering and Quality Systems work, presented in an anonymized and regulator-conservative manner. Rather than focusing on outcomes or claims, these examples highlight the decision logic, documentation discipline, and risk-based approach required to sustain compliant design controls, risk management, and change governance under FDA and EU regulatory expectations.

The case studies are intentionally sequenced to reflect how Quality credibility is built in practice:

• Design Verification: Statistical Rationale demonstrates how objective data analysis, statistical assumptions, and traceability form the foundation of defensible design verification.
   
• Lifecycle Risk Management System (ISO 14971) shows how verification evidence is integrated into coherent, maintainable risk management files across legacy and active products.
   
• Design Change & Sterilization Impact Control illustrates how design, process, and sterilization changes are assessed and implemented without compromising design intent, risk controls, or inspection readiness.
   

Together, these examples represent ENQUAL’s approach to risk-informed decision-making, design control integrity, and inspection-ready quality execution throughout the product lifecycle.

A representative engagement demonstrating how statistical assumptions, verification data, and traceability were aligned to produce regulator-defensible design verification evidence. 

A portfolio of parenteral combination delivery systems required defensible design verification evidence to support ongoing lifecycle activities under FDA and EU regulatory expectations. Functional verification studies had been executed, but the statistical assumptions, acceptance logic, and linkage to design requirements were not consistently documented in a way that would withstand regulatory scrutiny.

The organization needed verification outputs that were not only technically correct, but statistically justified, traceable, and inspection-ready, with clear alignment to Design History File (DHF) and Risk Management File expectations.

ENQUAL supported the development of a standardized design verification reporting framework that defined:

• Statistical strategy and assumptions (including normality assessment and hypothesis testing approach)
   
• Sample size rationale aligned to design requirements and risk
   
• Clear acceptance criteria and decision logic
   
• Traceability between User Needs, Design Inputs, verification evidence, and risk controls
   

Functional verification data were analyzed using Minitab and JMP, applying appropriate statistical methods to support objective verification conclusions. Outputs were integrated into DHF-supporting documentation, including:

• Verification summary reports
   
• Traceability matrices linking requirements, verification results, and risk controls
   
• DHF index and supporting document updates
   
• Verification, build, shipping, and conditioning protocols and reports based on laboratory data
   

This approach ensured verification evidence was both technically sound and regulator-defensible, with consistent documentation that could be reused across lifecycle activities.

The engagement resulted in inspection-ready verification documentation that supported ongoing design control, change management, and risk management activities for parenteral combination products. Statistical rationales were clearly documented, traceable, and aligned to regulatory expectations, enabling confident quality decision-making and sustained DHF integrity throughout the product lifecycle.

A representative engagement illustrating the development of a coherent, inspection-ready risk management framework integrating hazard analysis, FMEA, and user-related risk across the product lifecycle. 

Legacy and active combination products required alignment with current ISO 14971 risk management expectations across the full product lifecycle. Existing risk documentation had evolved over time, resulting in fragmented Hazard Analyses, inconsistent linkage between verification evidence and risk controls, and limited traceability from User Needs through residual risk acceptance.

The organization needed a structured, inspection-ready risk management system that could support ongoing design changes, verification activities, and regulatory expectations without disrupting established quality systems.

ENQUAL supported the development and implementation of a standardized lifecycle Risk Management File framework aligned with ISO 14971 principles. This included:

• Development and remediation of Hazard Analyses aligned to intended use and user interaction
   
• Integration of cross-functional risk analyses, including Design FMEA (dFMEA), Use FMEA (uFMEA), and Process FMEA (pFMEA)
   
• Creation and alignment of User Task Analysis and user-related risk documentation (URRA) to support usability and human factors considerations
   
• Establishment of Risk Management Plans and Risk Management Summary Reports to ensure consistent governance and residual risk justification
   
• Alignment of risk controls to design inputs, verification evidence, and traceability matrices to maintain DHF and RMF integrity
   

This system-level approach ensured risk management activities were repeatable, traceable, and maintainable across lifecycle events.

The resulting Risk Management Files provided a coherent, regulator-ready view of product risk, supporting ongoing design verification, change control, and inspection readiness activities. Risk documentation was standardized, traceable, and aligned to ISO 14971 expectations, enabling confident quality decision-making across both legacy and evolving combination products. 

A representative engagement showing how design, process, and sterilization changes were assessed and implemented while preserving DHF, RMF, and inspection readiness. 

Ongoing lifecycle management of parenteral combination products required robust Quality oversight of design, process, and sterilization changes driven by both external vendors and internal manufacturing sites. Changes included material updates, process modifications, and sterilization-related adjustments that had the potential to impact product performance, design verification, and residual risk profiles.

The organization needed a disciplined, repeatable approach to design change impact assessment that preserved Design History File (DHF) and Risk Management File (RMF) integrity while enabling timely implementation of necessary changes across multiple stakeholders.

ENQUAL supported Quality governance for design and process change assessments, ensuring changes were evaluated holistically across design controls, verification, and risk management. Key activities included:

• Quality impact assessment of vendor-driven and internally driven design and process changes, including changes associated with sterilization methods and parameters
   
• Evaluation of change impact on design inputs, design verification evidence, and traceability matrices
   
• Assessment of downstream effects on Risk Management Files, including Hazard Analysis and applicable FMEA documentation
   
• Coordination with cross-functional teams (R&D, Manufacturing, Suppliers) to ensure alignment on change scope, documentation updates, and verification needs
   
• Support of change control documentation to maintain DHF and RMF consistency throughout implementation
   

This approach ensured changes were not evaluated in isolation, but within the context of design intent, verification evidence, and residual risk.

Design and process changes were implemented with clear, documented justification and traceability, preserving inspection readiness across lifecycle activities. Change assessments supported consistent decision-making, minimized unintended risk introduction, and maintained alignment between design controls, verification, and risk management documentation for combination products operating under FDA and EU regulatory expectations.

 This representative engagement reflects ENQUAL’s approach to lifecycle risk management, design control integration, and inspection-ready quality systems for combination products.