Navigating eQMS Today with Enzyme

This video provides an in-depth exploration of electronic Quality Management Systems (eQMS), focusing on the Enzyme platform, presented by Nicolle Cannon, CEO of Cannon Quality Group, and Jared Seehafer, CEO and co-founder of Enzyme. The webinar kicks off a series aimed at creating a safe learning environment for understanding eQMS, rather than a direct sales pitch. The discussion centers on when and why companies, particularly Medtech startups, should consider implementing an eQMS, highlighting the benefits of automation, improved compliance, cost reduction, increased productivity, enhanced traceability, and reduced documentation burden.

Jared Seehafer details Enzyme's design philosophy, which stems from a frustration with fragmented and difficult-to-use systems prevalent in both large enterprises and startups. Enzyme aims to be an all-in-one solution that integrates seamlessly with other business tools, designed for the "non-expert" user to prevent quality teams from becoming bottlenecks, and built to be lean yet scalable with intelligent, customizable defaults. The platform's core modules cover product (design control, risk management), process (document control, training, suppliers), and improvement (audits, complaints, non-conformances, CAPA), all interconnected with common platform capabilities like permissions, e-signatures, and data import/export.

A significant portion of the presentation focuses on Enzyme's recent major release, which introduces enhanced customizability, allowing clients to tailor record and form structures to their specific needs without requiring extensive technical expertise. The speakers also delve into critical considerations for eQMS implementation, such as the optimal timing for adoption (document control and training from day one), evaluating different platform trade-offs (ease of use vs. customizability, integration needs vs. all-in-one solutions), and essential ingredients for successful implementation, including executive buy-in and data readiness. The discussion concludes with a look at Enzyme's 2022 roadmap, outlining new modules, API enhancements, a dedicated mobile app, Zapier integration, and improvements to notifications and metrics.

Key Takeaways:

• Strategic eQMS Implementation Timing: While eQMS offers significant benefits, the speakers advise a phased approach. Electronic document control and training are recommended from day one for good organizational hygiene, saving time and money in the long run, while other modules like design control, complaints, or CAPA can be implemented incrementally as the company's needs and complexity evolve.
• Addressing System Fragmentation: A common problem in quality management is the use of disparate systems (e.g., Google Drive for documents, Docusign for signatures, Google Sheets for training) that don't communicate, leading to inefficiencies and compliance risks. Integrated eQMS solutions like Enzyme aim to consolidate these processes or connect them through robust integrations.
• eQMS Design Philosophy: Enzyme's core design principles include being an all-in-one system that connects to other tools, being user-friendly for non-experts across all company functions (not just quality teams), and offering scalability from lean startups to large enterprises with intelligent, customizable defaults.
• Importance of Integration: Enzyme distinguishes itself through deep integrations with common business tools such as Salesforce, Zendesk, Slack, G Suite, GitHub, and Jira. This allows companies to leverage existing tech stacks without manual data entry or syncing issues, ensuring the eQMS reflects real-time operational data.
• Customization without Complexity: Enzyme's latest release offers significant customization of record and form structures, allowing clients to adapt the system to their specific quality processes. This balances the need for tailored solutions with ease of use, avoiding the requirement for "PhDs in the system" often associated with highly configurable platforms.
• Robust Compliance and Security: Enzyme is 21 CFR Part 11 compliant, SOC 2 Type 2 certified, and operates under an ISO 9001 quality system. Its architecture on Amazon Web Services (AWS) ensures data integrity, security (encryption in rest and transit), and isolation of customer data (single-tenant architecture), which is a critical evaluation point for regulated industries.
• Streamlined Onboarding and Support: Enzyme emphasizes a rapid and thorough onboarding process, aiming for full system adoption and data migration within 30 days. They offer multiple levels of training (admin, power user, general user) and continuous support via in-app chat and email, with options for dedicated support for larger organizations.
• Comprehensive Module Coverage: The platform covers essential quality processes including Design Control (with granular traceability), Risk Management (14971 compliant hazard analysis), Document Control (automatic numbering, PDF generation, redlines), Training Management (curricula, quizzes), Supplier Management, Audits, Complaints, Non-Conformances, and CAPA.
• Validation Approach for Software Releases: Enzyme manages its own product validation, providing extensive reports for customers to review and approve, which is typically sufficient for most companies. For custom code integrations, a collaborative validation process is undertaken with the client. Major releases require significant revalidation, while minor releases and patches (e.g., security fixes) are handled with less client intervention, though options for controlling deployment timing exist for critical clients.
• Key Trade-offs in Platform Evaluation: When selecting an eQMS, companies should consider trade-offs between ease of use and customizability, the need for integration versus an all-in-one solution, and whether a purpose-built QMS or a more generic tool (like a PLM system with QMS functionality) is appropriate for their specific needs.
• Critical Success Factors for Implementation: Successful eQMS rollout hinges on executive and cross-functional buy-in to prevent the system from becoming an isolated quality silo, having data ready for migration, understanding necessary procedural changes, and ensuring a dedicated team is available for training.
• Future Roadmap: Enzyme's 2022 roadmap includes new modules (eTMF, BOM, Test Case Management), platform enhancements (more robust API, dedicated mobile app, Zapier integration), and improvements to notifications and metrics.

Tools/Resources Mentioned:

• eQMS Platform: Enzyme
• Consulting Firm: Cannon Quality Group, LLC
• File Storage: Google Drive, Dropbox, Box, OneDrive
• E-signatures: Docusign
• Spreadsheets: Google Sheets
• CRM: Salesforce, Veeva CRM (mentioned in company context)
• Customer Service: Zendesk
• Communication: Slack
• Productivity Suite: G Suite
• Code Storage: GitHub
• Project Management: Jira
• Middleware/Integration Platform: Zapier
• Cloud Infrastructure: Amazon Web Services (AWS)
• Certification Body: Dekra (for ISO 9001)
• Competitor eQMS Platforms: Greenlight Guru, MasterControl, Qualio
• Medical Device Companies: Medtronic, Stryker, Abbott

Key Concepts:

• eQMS (Electronic Quality Management System): A software system designed to manage and automate quality processes and documentation in regulated industries.
• Design Control: A systematic process that ensures a medical device or product meets user needs and intended uses, from conception to production.
• Risk Management: The systematic application of management policies, procedures, and practices to the tasks of analyzing, evaluating, controlling, and monitoring risk.
• Document Control: The management of documents throughout their lifecycle, including creation, review, approval, distribution, and archiving, ensuring compliance and traceability.
• Training Management: System for planning, delivering, tracking, and documenting employee training to ensure competency and compliance.
• Supplier Management: Processes for selecting, evaluating, monitoring, and managing suppliers to ensure the quality of purchased goods and services.
• Audits: Systematic, independent, and documented processes for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled.
• Complaints: Records and processes for managing customer feedback, issues, or concerns related to a product or service.
• Non-Conformances: Records and processes for managing deviations from specified requirements or procedures during product or process execution.
• CAPA (Corrective and Preventive Action): A system for investigating and addressing the root causes of non-conformances and other quality problems to prevent recurrence or occurrence.
• Traceability: The ability to track the history, application, or location of an item or activity by means of recorded identification.
• 21 CFR Part 11: Regulations from the FDA that set forth the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures.
• ISO 9001: An international standard for quality management systems (QMS).
• SOC 2 Type 2: A report on the controls at a service organization relevant to security, availability, processing integrity, confidentiality, or privacy.
• MD SAP (Medical Device Single Audit Program): A program allowing a single audit to satisfy the requirements of multiple regulatory jurisdictions.
• Single-Tenant Architecture: A software architecture where each customer has their own independent instance of the software and supporting infrastructure.
• Validation: The process of establishing documented evidence that provides a high degree of assurance that a specific process, system, or activity will consistently produce a result meeting its predetermined specifications and quality attributes.
• Configuration vs. Customization: Configuration refers to setting up existing features within a system, while customization involves modifying the underlying code or structure to create new features or behaviors.

Examples/Case Studies:

• Enzyme Dogfooding: Enzyme uses its own eQMS platform to manage its internal design history file (DHF), user needs, requirements, and verification/validation processes, demonstrating the product's applicability.
• Manual Systems: Examples of common manual quality systems include storing documentation in Google Drive/Dropbox, using Docusign for e-signatures, and managing training matrices in Google Sheets, which often lead to outdated records and audit concerns.
• Legacy System Integration: A specific client case involved integrating Enzyme with a legacy system that didn't use standard APIs, requiring custom development and a collaborative validation effort with the client's team.
• Digital Migration: The speaker mentioned clients, particularly during COVID-19, who had relied on physical file cabinets for 40 years and needed to transition to digital document control and training, sometimes opting for only these basic eQMS functionalities.