Why your business needs a cloud-based quality management system

This video provides an in-depth exploration of the critical shift from paper-based to cloud-based quality management systems (QMS) within the life sciences industry. Presented by Kelly Stanton, Director of Quality at Qualio, at the American Biomanufacturing Summit 2022, the session highlights why digital, cloud-powered QMS solutions are no longer just an option but an indispensable necessity for quality-conscious businesses aiming to bring life-saving products to market faster. Stanton, drawing from her two decades of experience in pharmaceutical and medical device sectors, underscores the inefficiencies of traditional paper systems and champions a lean, efficient, and compliant approach to quality management that prioritizes actual regulatory requirements over excessive, often unnecessary, documentation.

The presentation systematically breaks down the challenges posed by paper-based quality systems, such as the creation of organizational silos, the inordinate amount of time spent on administrative tasks like manual data entry into spreadsheets, and the inability to effectively analyze and leverage critical data for improvement. Stanton reveals compelling statistics, noting that 38% of companies still rely solely on paper and spreadsheets for quality work, with 25-50% of a working day spent on administrative tasks and 50-53% on gathering and tracking information for QA, auditing, and training. She argues that this focus on manual control prevents organizations from dedicating resources to quality improvement, hindering their journey towards a "world-class" quality posture where processes actively support activities and patient safety.

Transitioning to the benefits, the speaker elaborates on how cloud-based eQMS solutions address these pain points by uniting teams, processes, and data. Key advantages include enhanced data availability, reduced manual data entry, and the power of API integrations to consolidate information from disparate tools like learning management systems, ERPs, Jira, Asana, and Git repositories into a central source of truth. This flexibility, configurability, and remote accessibility are crucial in today's globalized and often remote work environments. Stanton also provides practical migration tips, emphasizing the importance of asking the right questions, electing a change champion, and avoiding the "paving the cow path" pitfall—where existing, inefficient paper processes are merely digitized without being optimized for the new electronic environment. She illustrates these concepts with case studies of pharmaceutical manufacturers, Irresist and Expression Therapeutics, demonstrating successful transitions and the resulting efficiencies and audit readiness.

The discussion culminates with a focus on audit best practices and regulatory acceptance. Stanton asserts that an electronic QMS ensures perpetual audit readiness, eliminating the weeks of preparation typically associated with gathering physical documents. It facilitates easier information flow, controlled access via permissioning, and real-time tracking of audit findings and corrective actions (CAPAs), significantly reducing administrative overhead and meeting times. In the Q&A segment, she addresses the critical issue of regulatory acceptance, confirming that agencies globally, including those outside the U.S. and under PICS, generally accept electronic systems, provided the control of data, information, and configuration can be clearly demonstrated. She also offers valuable advice on managing quality touchpoints with a heterogeneous network of partners (CROs, suppliers), advocating for a risk-based approach in procedures rather than overly prescriptive requirements for specific e-signature tools, thereby promoting flexibility and trust in vendor qualification.

Key Takeaways:

• Imperative for Digital Transformation: A significant portion of life science companies (38%) still rely on paper and spreadsheets for quality management, leading to substantial inefficiencies and hindering progress towards quality improvement.
• Inefficiencies of Paper Systems: Paper-based systems create organizational silos, demand excessive administrative time (25-50% of a workday on data entry/reporting), and prevent effective data analysis, diverting resources from critical quality improvement initiatives.
• Cloud-Based eQMS Benefits: Electronic Quality Management Systems (eQMS) facilitate faster operations, unite teams and processes, make data readily available for analysis, and eliminate the need for manual data transcription, thereby enhancing overall efficiency.
• Strategic API Integrations: A robust eQMS acts as a central source of truth, leveraging API integrations to pull data from other essential tools (e.g., LMS, ERP, Jira, Asana, Git), allowing different teams to work in their preferred systems while maintaining quality oversight.
• Flexibility and Accessibility: Cloud-based eQMS offers flexibility, configurability, and remote access, which are crucial for distributed teams, outsourced operations, and adapting to evolving business structures, especially in a post-pandemic world.
• Audit Readiness and Efficiency: An eQMS ensures constant audit readiness by centralizing documentation, providing controlled access, and streamlining the tracking and resolution of audit findings and CAPAs, significantly reducing preparation time and administrative burden.
• Avoiding "Paving the Cow Path": When migrating to an eQMS, organizations should seize the opportunity to re-evaluate and optimize existing processes rather than simply digitizing inefficient paper-based workflows, which can lead to long-term pain and customization issues.
• Importance of a Champion: Electing a respected internal champion is vital for managing the cultural change associated with adopting a digital quality system, fostering buy-in, spreading awareness, and securing senior management support.
• Regulatory Acceptance: Regulatory agencies worldwide are increasingly accepting of electronic quality systems, provided companies can demonstrate robust control over data, information, and system configuration, focusing on the intent of regulations rather than specific methodologies.
• Managing Heterogeneous Partner Systems: When dealing with multiple partners using different quality or e-signature systems, procedures should be written to accept compliant electronic signatures generated in a compliant manner, rather than restricting to specific tools, leveraging vendor qualification and risk assessment to ensure data integrity.
• Risk-Based Approach to Procedures: Procedures should focus on areas of true risk where patient safety or product quality could be compromised, avoiding overly prescriptive details that can stifle efficiency and collaboration without adding significant value.
• Qualio's Lean Philosophy: Qualio advocates for a "lean" quality system that focuses on what is actually required by regulations, aiming for efficiency, simplicity, and ease of use to make quality management more effective and even "fun."

Tools/Resources Mentioned:

• Qualio: A cloud-based quality management software.
• Jira, Asana, Git: Examples of tools that can be integrated with an eQMS via APIs, particularly for software development and project management.
• Adobe Sign, Docusign: Examples of electronic signature methodologies discussed in the context of partner integrations.
• G2 Reviews: A platform where customers can review software, mentioned as a source of customer feedback for Qualio.

Key Concepts:

• Cloud-based Quality Management System (QMS): A system for managing quality processes and documentation hosted on cloud infrastructure, offering remote access, scalability, and integration capabilities.
• Electronic Quality Management System (eQMS): A digital system that automates and manages quality processes, documentation, and records, replacing traditional paper-based methods.
• "Paving the Cow Path": A term describing the mistake of digitizing existing, often inefficient, manual processes directly into a new system without first optimizing or redesigning them.
• Lean Quality System: An approach to quality management that focuses on efficiency, eliminating waste, and adhering strictly to essential regulatory requirements rather than excessive or redundant documentation and processes.
• API Integrations: The ability of software systems to communicate and exchange data with each other, allowing for a unified view of information across different platforms.
• Regulatory Compliance (FDA, EMA, PICS): Adherence to standards and regulations set by bodies like the U.S. Food and Drug Administration, European Medicines Agency, and Pharmaceutical Inspection Co-operation Scheme, which are critical in the life sciences.

Examples/Case Studies:

• Irresist: A pharmaceutical manufacturing company with 75 users, producing OTC products. They transitioned from a paper-based system to Qualio's eQMS, expanding quality participation from 6 core QA staff to 60 people across the organization. This shift enabled them to efficiently maintain documentation for hundreds of specialty therapeutics and become continuously ready for FDA audits.
• Expression Therapeutics: A company that built a new 43,000 square foot manufacturing facility and proactively adopted an eQMS from day one, going paper-free from the start. This allowed them to focus their time and resources on developing their manufacturing processes, as their quality system processes (like document control and training) were already efficiently managed electronically.