Quality Digest LIVE, October 20, 2017

This video from Quality Digest LIVE, dated October 20, 2017, provides an in-depth exploration of quality management topics, with a significant focus on the transformative impact of cloud-based Quality Management System (QMS) software solutions. The program features an interview with Frank de Fish, Senior Vice President and General Manager of Veeva Systems, who discusses how cloud QMS empowers quality departments and shifts the dynamic between IT and quality teams. Additionally, the episode covers the importance of ISO 13485:2016 for quality management in the medical device sector and briefly touches upon data interoperability in intelligent supply chains and even an unusual renewable energy source.

The core of the discussion centers on the evolution of QMS from traditional on-premise, IT-driven systems to agile, user-centric cloud platforms. De Fish explains that historically, IT departments held the sole expertise for procuring, installing, and maintaining QMS software, often leading to solutions that didn't fully meet quality teams' needs. Cloud QMS, by transferring the technical burden to the software vendor, allows quality departments to "take the driver's seat." This shift fosters a stronger, more collaborative relationship between quality and IT, as IT can now focus on supporting the business rather than managing complex software infrastructure.

De Fish elaborates on the three key benefits of cloud QMS: enhanced usability, flexibility, and accessibility. Cloud software, much like consumer applications such as Google or Amazon, prioritizes an intuitive user experience, making it easier for non-technical users to adopt and utilize. Its flexibility stems from point-and-click configuration rather than complex coding, enabling quality teams to adapt the system quickly to new ISO standards or best practices without relying on IT. Furthermore, cloud QMS offers universal access via any internet browser, from any device, anywhere in the world, extending its reach to external suppliers, contract manufacturers, and even auditors, facilitating seamless collaboration and compliance.

The interview highlights tangible business improvements enabled by cloud QMS, drawing parallels to the advancements seen in CRM software when sales organizations gained decision-making power. These improvements include the ability to integrate external partners into the QMS for activities like completing investigations, signing off with 21 CFR Part 11 compliant electronic signatures, or uploading batch files directly, thereby eliminating blind spots in audit trails and enhancing accountability. Cloud QMS also significantly increases speed, allowing quality teams to generate reports and implement workflow changes in response to regulatory shifts much faster, without lengthy IT queues. The discussion also touches upon the critical role of ISO 13485:2016 in the medical device industry, emphasizing its importance for managing the high-risk profile of medical products and ensuring both regulatory compliance and financial performance.

Key Takeaways:

• Empowerment of Quality Departments: Cloud-based QMS solutions fundamentally shift control from IT to quality teams, allowing them to select, manage, and optimize their quality systems directly. This transition enables quality departments to make quicker, more informed decisions that better align with their operational needs.
• Enhanced Usability and Adoption: Cloud QMS prioritizes user-friendliness, mirroring the intuitive interfaces of consumer web applications. This ease of use is crucial for widespread adoption within an organization, especially since not all users interact with the QMS daily, ensuring better data visibility and decision-making.
• Flexibility Through Configuration, Not Code: Unlike traditional software requiring extensive coding, cloud QMS allows modifications through simple point-and-click configurations. This empowers quality professionals, even those without coding expertise, to adapt the system to evolving regulatory requirements (e.g., new ISO standards) and best practices efficiently.
• Universal Accessibility: Cloud QMS can be accessed from any device, browser, or location with an internet connection, eliminating the need for complex VPNs or specialized installations. This broad accessibility facilitates collaboration across internal teams and external partners like suppliers and contract manufacturers.
• Streamlined Procurement and Cost Predictability: The procurement process for cloud QMS is significantly simpler, as it eliminates the need for purchasing and maintaining additional hardware, software, or network infrastructure. Companies benefit from predictable subscription-based licensing, simplifying total cost of ownership analysis.
• Improved External Partner Integration and Compliance: Cloud QMS enables seamless integration with external suppliers and contract manufacturers, allowing them to directly participate in QMS processes, such as completing investigations, uploading batch files, and providing 21 CFR Part 11 compliant electronic signatures. This enhances accountability and closes audit trail blind spots.
• Increased Operational Speed and Agility: Quality teams gain the ability to generate reports and implement workflow changes in response to regulatory updates or internal needs without lengthy delays caused by IT backlogs. This agility is critical for maintaining compliance and continuous improvement in a dynamic regulatory landscape.
• Criticality of ISO 13485 for Medical Devices: ISO 13485:2016 is highlighted as a paramount standard for quality management systems in the medical device industry. Its proper implementation is essential for mitigating the high-risk profile of medical products, ensuring patient safety, and balancing regulatory adherence with business performance.
• Value of Expert Guidance for Standards: The discussion emphasizes the importance of handbooks and guides written by technical committees (like ISO TC 210 for ISO 13485) to help organizations, auditors, certification bodies, and regulatory agencies better understand and implement complex standards.
• Future Innovation in Quality Software: The shift to cloud platforms is expected to drive significant innovation in quality software, similar to how cloud adoption revolutionized CRM. This will lead to continuous improvements in quality processes and tools, further optimizing operations in regulated industries.

Tools/Resources Mentioned:

• Veeva Systems: A company providing cloud-based software solutions for the life sciences industry.
• Veeva Vault QualityOne: A specific cloud-based QMS product from Veeva Systems.
• ISO 13485:2016: The international standard for quality management systems for medical devices.
• ISO 13485:2016 Medical Devices: A Practical Guide: A handbook published by ISO to aid in the understanding and implementation of ISO 13485:2016.

Key Concepts:

• Cloud QMS (Quality Management System): A QMS delivered as a service over the internet, eliminating the need for on-premise hardware and IT management, offering benefits like scalability, accessibility, and ease of use.
• 21 CFR Part 11: Regulations issued by the FDA concerning electronic records and electronic signatures, which are critical for ensuring the integrity and authenticity of digital data in the pharmaceutical and life sciences industries.
• ISO 13485: An international standard that specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements.
• Data Interoperability (in QMS context): The ability of different QMS components and external systems (e.g., with suppliers) to exchange and make use of data, crucial for maintaining a complete and accurate audit trail and ensuring compliance.

Examples/Case Studies:

• New Chapter and Procter & Gamble: Both companies are mentioned as users of Veeva Vault QualityOne, illustrating its applicability across different organizational sizes (New Chapter being smaller, P&G a large parent company).