Selecting the Right EDMS Vendor One Size Does NOT Fit All! Recording 04122012

This video provides an in-depth exploration of the critical process for selecting the right Electronic Document Management System (EDMS) vendor, specifically tailored for companies within the life sciences industry. Presented by Bob Lucazi, Vice President and Subject Matter Expert for Life Sciences at USDM Life Sciences, the webinar emphasizes that a "one-size-does-not-fit-all" approach is essential. The discussion is framed around best practices for Enterprise Content Management (ECM) and regulatory compliance, drawing on Lucazi's extensive experience in quality assurance and regulatory affairs across pharmaceutical, biotech, and medical device sectors.

The presentation outlines a structured, multi-step methodology for EDMS vendor evaluation, beginning with a thorough internal needs analysis. This foundational step involves developing a User Requirement Specification (URS) by interviewing various organizational groups, distinguishing between mandatory and 'nice-to-have' features, and critically, identifying regulated versus non-regulated content. The process then progresses through identifying a long list of potential vendors, gathering basic information, conducting user checkpoints to assess initial findings, and narrowing down to a short list of two or three vendors.

A significant portion of the webinar is dedicated to the detailed criteria for evaluating EDMS solutions. This includes general content management capabilities like forms, templates, record retention, collaboration, and workflow management. Crucially for modern enterprises, integration capabilities with existing systems such as SharePoint, ERP, HR, or Electronic Lab Notebooks (ELN) are highlighted. Other key areas of evaluation cover document management features (versioning, life cycles, search, annotations), storage mechanisms (native object storage, legal holds, timestamps), data management (database technology, audit trails, reporting), security (access control, roles, LDAP), and networking aspects (external access, portals). The speaker also touches upon non-functional requirements like ease of use, licensing, training, and ongoing support.

The video concludes by discussing the necessary deliverables from the selection process, including the URS, a comprehensive comparison spreadsheet, storyboards for vendor demonstrations, and a final recommendation report. A crucial financial aspect, the capital expenditure report, is also covered, emphasizing the importance of demonstrating ROI and securing management buy-in. A brief case study illustrates the practical application of this methodology, highlighting factors such as budget constraints, the need for a SaaS environment, and unexpected requirements like Electronic Common Technical Document (ECTD) capabilities, which ultimately influenced the final vendor selection based on life sciences experience and customer references.

Key Takeaways:

• Structured EDMS Selection Process: A successful EDMS selection requires a methodical, multi-step approach, starting with a comprehensive needs analysis and culminating in a well-justified vendor selection.
• Thorough Needs Analysis (URS): Begin by developing a detailed User Requirement Specification (URS) through interviews with diverse user groups, distinguishing between mandatory and 'nice-to-have' features. This document serves as the foundation for all subsequent evaluation.
• Regulated vs. Non-Regulated Content: Clearly differentiate between regulated and non-regulated content within your organization, as regulated content necessitates validation and adherence to standards like 21 CFR Part 11 and GxP.
• Stakeholder Engagement: Involve key decision-makers and users throughout the evaluation process, especially during vendor demos, to ensure alignment and prevent miscommunication or re-evaluation later on.
• Scenario-Based Demos: For vendor demonstrations, create specific storyboards or scenarios based on your company's unique needs and workflows. This ensures vendors showcase relevant functionalities rather than generic features.
• Comprehensive Proposal Review: Scrutinize vendor proposals not just for pricing, but also for hidden costs, different licensing models, included maintenance, and the type of ongoing support provided (e.g., automated upgrades, validation scripts).
• Critical EDMS Criteria: Evaluate vendors across a broad range of criteria including general content management (forms, templates, collaboration, workflow), document management (versioning, life cycles, search, annotations), storage, data management (audit trails, reporting), security (access control, roles, LDAP), and networking.
• Integration Capabilities: Assess the vendor's ability to integrate with your existing enterprise systems (e.g., SharePoint, ERP, HR, LMS, ELN, SAP) through APIs or pre-built connectors, as this is crucial for a cohesive IT ecosystem.
• Migration Strategy for Existing Systems: If migrating from an existing EDMS, inquire about the vendor's experience with data migration, available migration tools (e.g., Bulldozer, Vance Partners), and verification processes to ensure data integrity.
• Regulatory Compliance as a Core Factor: For life sciences companies, regulatory compliance (e.g., Part 11, GxP, validation support) must be a paramount consideration in the EDMS selection, influencing audit trails, security, and document control features.
• Ease of Use and User Adoption: Prioritize ease of use, as a complex system may lead to underutilization, turning an expensive EDMS into merely a file store rather than a fully leveraged document management solution.
• Financial Justification and Management Buy-in: Prepare a capital expenditure report, including ROI analysis, to present to management. This financial justification is critical for securing budget and approval for the EDMS investment.
• Vendor's Industry Experience and Customer Base: Consider the vendor's specific experience within the life sciences industry and their customer references, as this often indicates a deeper understanding of regulatory requirements and industry-specific challenges.
• Cloud-Based (SaaS) Solutions: Explore cloud-based or Software as a Service (SaaS) EDMS options, which can offer cost-effectiveness, scalability, and enhanced collaboration features, as exemplified by products like Box.net.

Tools/Resources Mentioned:

• EDMS Vendors: Documentum, OpenText, MasterControl, QUMAS, PharmaReady, GRM, ETQ (Quality Management System with EDMS component), Box.net (cloud-based product).
• Enterprise Systems: SharePoint, ERP (Enterprise Resource Planning), SAP, LMS (Learning Management System), ELN (Electronic Laboratory Notebook).
• Migration Tools: Bulldozer, Vance Partners (includes migration and verification tools), a German-based migration tool.

Key Concepts:

• EDMS (Electronic Document Management System): A system used to manage and track electronic documents and electronic images of paper-based information.
• ECM (Enterprise Content Management): A broader set of strategies, methods, and tools used to capture, manage, store, preserve, and deliver content and documents related to organizational processes.
• URS (User Requirement Specification): A formal document detailing the needs and expectations of the users for a new system or software.
• RFP (Request for Proposal): A document issued by an organization to solicit proposals from potential vendors for a desired service or product.
• ROI (Return on Investment): A performance measure used to evaluate the efficiency of an investment or compare the efficiency of several different investments.
• GxP (Good x Practice): A collection of quality guidelines and regulations for various aspects of regulated industries, including Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), etc.
• 21 CFR Part 11: Regulations issued by 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.
• GAMP (Good Automated Manufacturing Practice): A series of guidelines for manufacturers and users of automated systems in the pharmaceutical industry.
• ECTD (Electronic Common Technical Document): An interface and a standard for the electronic transfer of regulatory information and applications.
• SaaS (Software as a Service): A software distribution model in which a third-party provider hosts applications and makes them available to customers over the Internet.
• API (Application Programming Interface): A set of defined rules that enable different applications to communicate with each other.
• LDAP (Lightweight Directory Access Protocol): A protocol for accessing and maintaining distributed directory information services.

Examples/Case Studies:

• Client EDMS Selection Case Study: A recent client sought an EDMS vendor, requiring a SaaS environment and operating within a specific budget. The process involved gathering user requirements from departments like regulatory, QA, validation, IT, legal, and management. An unexpected requirement for ECTD capabilities emerged, narrowing the vendor list. The final decision between two vendors (both around $100,000) hinged on factors like life sciences experience (vendor one) versus local support and ease of use (vendor two), with the client ultimately choosing vendor one due to its strong life sciences background and customer base.
• Integrated Systems Example: An example was provided of a company that integrated its EDMS with a Learning Management System (LMS), an Electronic Laboratory Notebook (ELN), and SAP's HR module. This integration allowed for automated checks: when an operator used equipment, the system would verify via SAP and the LMS if the operator had completed the necessary training, with SOPs and training records stored in the EDMS.