Manufacturers shifting to digital validation must create a culture of quality, experts said on an ISPE webinar, “Quality Culture Matters: Key to Unlocking the Digital Validation Power.” ISPE has recently released ISPE Good Practice Guide: Digital Validation, which emphasizes a robust quality culture as foundational for successful implementation.
“More companies will make this switch, as traditional validation methods are no longer sufficient for today’s advanced technologies,” said Dori Gonzalez-Acevedo, CEO and co-founder of ProcellaRX and a member of the ISPE digital validation subcommittee.
Digital validation innovations include AI and machine learning (ML) models, real-time monitoring systems, blockchain for data integrity, augmented and virtual reality, IoT-enabled smart devices, personalized medicine platforms, continuous manufacturing systems, genomics and bioinformatics tools, wearables and digital health technologies.
As a result of these advancements, “the shift is no longer optional,” Gonzalez-Acevedo stressed. Digital validation tools bridge the gap between current and advancing technologies, offering predictive, adaptive and proactive solutions with real-time risk assessments for faster decision making and live reporting. They also allow manufacturers to scale operations and adapt processes to meet new regulatory requirements as they arise.
Common risks when making the switch
Manufacturers moving to digital validation can take steps to avoid some common risks, said Amy Kuntzman, principal consultant at CAI. “Companies will sometimes settle for a paper on glass implementation, rather than focusing on a true digitalization,” Kuntzman said. Kuntzman advises companies to actively engage with their implementation partner to ensure they are leveraging all functionalities available.
It’s also important to anticipate and plan for process changes. If companies continue to use the same processes, “you’re just taking the process that you have and executing it on a screen rather than on paper,” Kuntzman said. “This gives you the ability to make the same mistakes faster and at higher volume.”
Khaled Moussally, executive vice president of clients and regulatory relations with Compliance Group, underscored the importance of inspection readiness, which will mean changes for companies accustomed to paper processes. The ISPE Good Practice Guide specifically addresses this, as well as how to work differently with regulators, Moussally said.
ISPE Good Practice Guide
The ISPE Good Practice Guide presents a compliant approach to using digital validation tools. It covers:
- Digital validation concepts
- Crafting a compelling business case, including establishing ROI
- Digital validation system implementation and governance
- Regulatory considerations and impact
- Future advancements in digital validation tools.
The guide emphasizes that a robust quality culture is crucial for the successful implementation of digital validation and discusses strategies to foster this culture within organizations, including breaking down silos and encouraging integrated collaboration.
“If you don’t have the right culture for it, it will fail,” said Moussally, adding that “strong leadership commitment is essential,” along with organizational change management.
Leading the change
“For successful governance of digital validation, manufacturers will need a solid framework that aligns with project and implementation objectives,” said George Brunner, chief data scientist at Acumen Analytics. They also need a practical digital validation and adoption strategy, robust change management and an eye to continuous improvement.
Also vital is stakeholder communication about updates, modifications and new procedures, as transparent communication builds trust and reduces resistance to change.
Finally, manufacturers need an effective enterprise steering committee with clearly defined roles and responsibilities. When issues arise, “the steering committee provides a central authority for swift, informed resolution,” Brunner said. “This keeps projects moving forward efficiently.”
Today’s manufacturers “have the opportunity to lead the change,” Gonzalez-Acevedo said. By focusing on quality culture and taking steps to drive effective change and continuous improvement, manufacturers can enhance risk management and realize the full advantages of digital validation tools.
Learn more about the ISPE Good Practice Guide: Digital Validation.
ISPE members have exclusive access to previously recorded ISPE webinars. ISPE members: Access the webinar “Quality Culture Matters: Key to Unlocking the Digital Validation Power.”
Nonmembers: Consider becoming an ISPE member today.