By: Tamara Briggs, Process Improvement Analyst
History has taught us that the only constant is change, however in today’s industries, the rate of change is happening at an increasingly, unmanageable rate. Axendia’s research on the future of change and configuration management revealed that over 50% of industry professionals worry that their current processes are too slow and cumbersome.
Daniel Matlis, President of Axendia, and Mike Jovanis, Vice President of Vault Quality at Veeva Systems, shared their perspectives on the challenges of change management in FDA regulated industries during an FDANews Webinar. Specifically, they discussed the importance of simplifying change management across the product life cycle. Topics of discussion included:
- Change Management Challenges
- Closed-loop Quality Processes
- Collaborating on Change Management
- Moving from Documents to Structured Data
- Becoming a Proactive Quality Organization
- Transforming Change Management Programs
Why are existing solutions not resolving or addressing current change management challenges in the life science industry?
Quality solutions were typically implemented reactively. This has become problematic over time, as local change control processes don’t always translate well into global ones. And, compliance requirements and timelines also differ based on geography or market. Change management needs people, process, and technology to work seamlessly together across the globe to identify gaps, determine the impact of a change, or collaborate on change activities. Gaining a holistic, global perspective is key for any successful change management program.
Managing Products Across the Product Life Cycle
Historically, the life science industry has had a very complex stage-gate product development and change management processes. Shifting to a product lifecycle approach allows industry to more effectively manage change and res
pond to post-approval issues such as:
- Supplier changes
- Process changes
- Customer inquiries
- Adverse events
- Regulatory findings
How Can Veeva Help Enable Integrated, Closed-Loop Change Management Approaches?
Mike Jovanis pointed out, “by implementing a modern cloud solution, such as the Veeva Vault suite of applications, we can provision the right level of security for each person or system. This allows us to connect relevant stakeholders, business functions, and applications – such as an ERP and PLM – for closed-loop change control processes and greater transparency.”
Collaboration on Change Management
Axendia’s primary research shows industry professionals believe that change management processes can be improved through better use of technology. Promoting effective and efficient collaboration with modern solutions brings all parties together, generates transparency for all stakeholders, and empowers stakeholders with the availability of information.
Moving from Documents to Structured Data
The life sciences industry appears to be obsessed with collecting, retaining, and hoarding data to meet statutory and regulatory requirements. However, FDA is shifting its focus to quality metrics reporting, and as a result, companies must change from managing static documents to managing structured data. Companies who are voluntarily participating in the Case for Quality initiative, and can show the FDA their commitment to quality, have the opportunity to shift from onsite to remote inspections. This allows regulators to focus on manufacturers that require more oversight.
Veeva has transitioned from being a content management vendor to introducing applications that encompass structured data, and workflows that apply to structured data. Learn how to become a more proactive organization and transform change management programs.