生物制药中实施基于风险的一体化 CQV 方法：现实挑战与组织变革

Having led and lived through this transition within a global biopharmaceutical manufacturing network, the author would like to share personal insights into the change management realities behind implementing an integrated, risk-based C&Q approach.

Background: Making Effective Use of Existing Engineering and Vendor Documentation and Testing

This means making effective use of existing documentation, testing, and vendor information, where appropriate, rather than repeating activities unnecessarily, provided the approach is predefined and supported by suitable engineering quality practices, risk assessment, and quality For example, Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) documentation and testing results can be used to support verification, without unnecessary repetition on site where justified and where functionality is not affected by transport or installation., This can also include using commissioning documentation developed under Good Engineering Practice (GEP) to support system verification and qualification deliverables.

Benefit: This can eliminate redundant testing and reduce cycle time and cost without compromising assurance, when supported by appropriate GEP, risk assessment, documentation, and quality oversight.

Integrated

This means designing commissioning and qualification as one continuous, coordinated lifecycle rather than as separate, duplicative phases with disconnected documentation and testing strategies. Engineering, CQV, and quality are engaged early—during requirements definition, design review, risk assessment, and, where applicable, FAT/SAT—rather than treating qualification as a late-stage activity after engineering delivery is complete.

Benefit: This can catch design and requirement gaps early, when they're less expensive to fix, instead of during formal qualification when a failure means schedule delay and rework. It also removes the friction during handoff and the duplicate documentation between commissioning and qualification teams.

Risk-based

This means aligning testing rigor and documentation with the intended purpose of the system and the results of system risk assessment, using product and process understanding to identify critical aspects and critical design elements that require focused verification. Not every system function or design element presents the same level of risk to product quality; applying the same level of effort uniformly can divert attention from the elements that matter most.

Benefit: This can support better allocation of engineering, CQV, and quality resources by focusing effort where risk to product quality is most significant and reducing unnecessary burden elsewhere—deeper scrutiny where patient/product risk is real and less bureaucratic overhead where it isn't.

The Combined Benefit: Why These Work as One Strategy, Not Three Separate Ideas

Together, an integrated, science-and-risk based C&Q approach can reduce duplicate activity, focus verification effort, and streamline documentation without compromising control. The rigor is redirected to where it actually protects product quality and patient safety, rather than spread evenly (and wastefully) across everything. This is also the argument regulators expect teams to be able to defend: reduced testing isn't a risk unless teams can demonstrate, through a documented and scientifically justified risk assessment, why the reduced effort is appropriate. That's the piece the author always comes back to in an US Food and Drug Administration (US FDA)/European Medicines Agency inspection. Reduced duplication is appropriate only when the company can demonstrate, through documented and scientifically justified risk assessment and verification strategy, that the selected approach is suitable for the intended use.

It Starts as an Organizational Change as Much as a Process Change

Before it is experienced as a documentation strategy or testing methodology, implementation of an integrated, risk-based C&Q approach is often an organizational and behavioral change. It challenges the status quo across validation, quality, automation, and engineering teams, and it touches a wide set of stakeholders—global engineering, global quality, manufacturing sciences, manufacturing operations, project management, and procurement.

The success of this transformation depends on a strong partnership between the three departments most directly affected: engineering, validation, and quality. But the partnership does not mean shared ownership. In practice, organizations need defined ownership for the transformation. Depending on company structure, CQV/validation may play a strong coordinating role, but successful implementation depends on close partnership among engineering, CQV, and quality, with engineering playing a central role in system delivery and verification and quality providing appropriate oversight. CQV/validation often sits at the interface of engineering and quality and can help coordinate translation of the approach into procedures and execution practices.

Build Buy-In Within the CQV/Validation Function and Align Early with Engineering and Quality Leadership

Before asking other departments to change, the validation team secure internal consensus on the new approach. Some team members may resist—often not out of principle, but because historically, they may be conservative by training and unclear as to what the new model is actually trying to achieve. Much of that resistance will likely dissolve with clear explanation of the intent behind the change. So, it is important that the value proposition for the change is clearly articulated.

It's equally important to equip skeptics with the tools to succeed under the new model. If digital or paperless execution tools are introduced as part of the implementation, ensure that personnel are trained and equipped to use them effectively and in accordance with site requirements. Alignment with engineering and quality teams at the department head-level also matters here, so validation staff aren't left to individually negotiate the change with their counterparts in other departments.

Bring Engineering and Quality Along Deliberately

Once validation is aligned internally, the next step is direct engagement with engineering and quality.

Engineering teams may push back, anticipating extra work and a loss of the flexibility to make ad-hoc decisions. To a real extent, they're correct—a higher standard of documentation rigor is part of the change. Quality teams, meanwhile, may worry that engineering isn't equipped to meet quality-level documentation and change management standards, and to some extent, that concern is valid too.

This is precisely where clear alignment and communication have to come from the top. Upper management needs to convey, unambiguously, that this is the direction the organization is taking—and why: it reduces timelines and cost, remains fully compliant with quality systems, and reflects an approach that regulatory bodies have already accepted across the industry. Executive endorsement makes it substantially easier for department heads to roll the new approach out to their own teams.

Make It a Visible, Cross-Functional Effort

Convene a joint meeting with all affected departments—engineering, validation, and quality—together in the same room. The shared setting itself sends an important message: this is a team effort, and success depends on collaboration across functional lines, not a mandate imposed by one department on another.

Follow that with department-specific sessions. Use flowcharts, real examples from live projects, and short videos to make the new process tangible. Bring in subject matter experts who have already executed the new approach to answer questions directly from process, facility, and automation teams. Throughout, the person leading this effort needs to stay visibly positive and energized—enthusiasm for change is contagious, and so, unfortunately, is skepticism.

Expect this to take more than one round of meetings. Comfort with a new way of working builds gradually, not instantly.

Start Small, Then Scale

Choose a smaller, less complex project for the first implementation. A contained pilot is easier to execute, provides genuine learning opportunities for the teams involved, and is simply more likely to succeed—which matters, because early wins build momentum for everything that follows.

Close the pilot with a formal lessons-learned session, and carry those lessons learned directly into the next project and the ones after it.

Expected Benefits of an Integrated, Risk-Based Approach

Published experience and case examples indicate that an integrated, risk-based approach can deliver benefits such as reduced redundancy, clearer focus, and improved efficiency when implemented effectively.

• Shorter project timelines: Shorter project timelines: greater focus on critical verification activities and less time spent on low-value duplication.
• Improved quality focus: Increased attention to the requirements, functions, and design elements most significant to product quality supports stronger overall assurance.
• Regulatory alignment: Regulatory alignment: a science- and risk-based approach is consistent with current regulatory expectations reflected in recognized guidance.
• Elimination of unnecessary testing: Activities not requiring formal qualification focus can be addressed through GEP and supporting engineering documentation.
• No duplicate testing: Qualification does not unnecessarily repeat what commissioning and other engineering verification activities have already adequately demonstrated.
• Genuine process understanding: Qualification reflects real engineering judgment rather than a generic checklist.
• Earlier engineering ownership: Process, automation, and facility engineering are directly involved in qualification decisions.
• Stronger cross-functional alignment: Engineering, validation, and quality come together early in the design phase, reducing friction between departments.
• Shared ownership: Defined cross-functional responsibilities: engineering, CQV, quality, and operations contribute throughout the lifecycle through clearly defined roles and coordinated execution.

Conclusion

Industry experience increasingly supports the view that integrated, risk-based C&Q approaches can deliver meaningful efficiency benefits when implemented with appropriate engineering practices, risk assessment, documentation, and quality oversight. These approaches support closer cross-functional collaboration, shorter project timelines, and a sharper focus on what matters most to product quality. The guidance describes the target state clearly; achieving it successfully depends not only on process redesign, but also on organizational alignment, role clarity, and sustained change management. An integrated, science and risk-based approach to CQV delivers real, measurable value: closer cross-functional collaboration, shorter project timelines, and a sharper focus on what actually matters to product quality. Just as importantly, this methodology has repeatedly withstood regulatory scrutiny in audits and inspections. The guidelines tell you what the end state looks like—getting there successfully depends on treating it, from day one, as a change management effort as much as a technical one.1