Top Seven Risks to Consider When Selecting a Life Science LMS

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1 Top Seven s to Consider When Selecting a Life Science LMS THE UNINTENDED CONSEQUENCES OF UNINFORMED DECISIONS IN THIS PAPER: Identifying and avoiding gaps in LMS functionality that may lead to critical risk.

2 The Unintended Consequences of Uninformed Decisions In a regulated industry so inherently risk-conscious, Life Science companies are often careful when evaluating an enterprise-wide Learning Management System (LMS) to ensure the system addresses the stringent needs of 21 CFR Part 11 and EU Annex 11. The fact is, many LMSs do not provide this functionality, or provide this functionality at various depths; in some cases these are not discovered until after the purchase is made. Not having the functionality needed to meet US and EU electronic recordkeeping requirements, such as automated version controls for training materials and electronic records and signatures, places undue compliance pressure on the QA team. Such LMS deficiencies can drive organizations to become more reliant on manual qualification processes to move their business forward. These workarounds increase the risk of data integrity errors, drain profitability, and, ultimately, expose the company to observations related to 21 CFR Part 11 and EU Annex 11. When purchasing an enterprise learning platform, making a well-informed LMS purchase decision is the best and only option. Yet, things have been known to go awry in the RFP or software evaluation process, because LMS vendors do not provide a full presentation of how these requirements are addressed in the application. In most cases, the Quality Assurance and IT teams in a Life Science organization are responsible for selecting an LMS that meets regulatory electronic recordkeeping requirements, or risk greater scrutiny during internal and external audits. In this paper, we provide the seven risk areas that QA and IT Validation teams should examine when evaluating an enterprise learning management system. LMS Functionality Gaps Lead to Cascading Consequences Functionality Gaps Manual Processes Human Error Loss of Control and Validation Increased Regulatory Cost of Remediation Loss of Revenue Buyer s Remorse Page 2

3 Top Seven s to Consider When Selecting a Life Science LMS s, Gaps and Remedies Life Science LMS solutions by definition are designed to facilitate the management of training activities, learner proficiency and compliance status, while mitigating the financial risks associated with non-compliance, quality deficiencies, poor policy distribution management, and inadequate training record management. A sound strategic approach for making your LMS work effectively across your footprint is to ratchet up the level of vigilance to identify potential vulnerabilities before they morph into post-purchase performance risks and gaps. Many of the features, functions, and user benefits that should be essential to your LMS can often be subordinated to bigger issues, bells, and whistles during vendor presentations, or not clearly identified during the needs assessment phase of the RFP. Despite these gremlins, there are steps you can take to eliminate these inherent risks upfront to ensure your organization is well-equipped and better prepared to meet its FDA-mandated regulatory compliance requirements. Make it a best practice to perform thorough due diligence, carefully assess the scope of your organization s learning management needs, and have your punch list ready. Drill down beyond your RFP vendor s service deliverables package. Ask them hard, probing questions about those features and functions not referenced in their proposals that matter most to your organization. Functionality risks associated with leading LMS system software will vary based on the specific needs and requirements of each user organization. We have outlined seven of the highest risk concerns and their corresponding gaps along with recommended remedies to help you detect and prevent them when choosing an LMS. 1 Training content lacks sufficient version control. The lack of version control raises the risk of human error from manually performing multiple version reconciliations, and updating a growing library of constantly changing training documents. Gap: No automated process for versioning training documents and updating training curriculum with the new version. This creates significant administrative inefficiency, and fuels the assumption, from a regulatory perspective, that your organization has failed to deploy and sustain a compliant quality initiative. This can expose you to potential 483 observations, CAPA directives, and increased scrutiny based on inspection outcomes. Remedy: Access to version control capability enables the elimination of manual reconciliations for an increasing volume of multiple material versions, and: Protects against the issuance of 483s, warning letters, and other audit remediation directives. Improves the operating efficiency of both Quality and System Administration. 2 Absence of automated esignatures, which elevates the level of incomplete training outcomes and record retention, and puts the maintenance of training documentation out of compliance with 21 CFR Part 11. Gap: esignatures do not automatically and appropriately append to each course introduced to the training program, requiring additional administrative activity and creating confusion for the learner. Remedy: Electronic records and signatures compliant with strict requirements of FDA 21 CFR Part 11 and EU Annex 11 that will provide: The esignature must be created at the moment of training completion and must maintain audit trails and security to ensure it is an unimpeachable record. Validation of systems to ensure accuracy, reliability, consistent intended performance, and the ability to discern invalid or altered records. Generation of accurate and complete copies of records in both human readable and electronic form suitable for inspection, review and copying by the regulatory agency. Page 3

4 Top Seven s to Consider When Selecting a Life Science LMS 3 Insufficient audit trail data on learner training items and curriculum profiles. Gap: No date and time-stamp capability, limited information on who made the change and what was changed, and the inability to retain the data for the appropriate period of time. This weakens the ability to create a comprehensive, end-to-end task audit trail, and hampers training program control and monitoring. The inability of an LMS to capture both new and old performance benchmarks, and having to manually monitor who is inputting system changes, the time and date the changes were made, and who made them, make that system non-21 CFR Part 11 compliant. Remedy: Secure, computer-generated, date and time-stamped audit trails independently record the date and time of operator entries and actions that create, modify or delete electronic records. 4 Deficient training plan approval process capability causes all management and administrative approvals to be done manually outside the LMS. Gap: Management unable to review individual training plans against employee job descriptions to confirm accuracy when hired, and updated when a change in role takes place. The margin for human error increases proportionally to the incidence of manual labor required to overcome the lack of automated processes, while additional staff will need to be deployed to support a manual review of the training program. Remedy: Automated, periodic reviews of training plan functionality: Reduces the reliance on manual, administrative activity. Can be tailored to conform to internal training record retention disciplines. Increases control, accountability, and oversight of training plan reviews. Page 4

5 Top Seven s to Consider When Selecting a Life Science LMS Inadequate audit-ready reports for administrators and managers that show the real-time qualifications status of learners. Gap: Managers and administrators must be able to have immediate notification of, and access to, the compliance and qualification level of their employees. These reports must also be presentable in an audit. They contain all relevant data so that it is clearly represented from an accurate and trustworthy source. Remedy: Real-time, automated training reports and notifications, detailing the compliance and qualification status of learners: Notifies both managers and system administrators by when an employee s assignment is overdue. Provides current, real-time access to training records. Produces audit-ready reports in.pdf format that contain report criteria, date/time stamps, page numbers, etc. Employees involved in the quality system cannot be grouped into automated roles based on job functions because the LMS features and corresponding functionality that govern the role-based training process are inadequate. Gap: In the absence of automated role-based training management features, individual training plans must be developed, evaluated, approved, and assigned manually, making human error a distinct possibility. These shortcomings can quickly raise auditor perceptions that training plans are inconsistently assigned. This would indicate that employees are not being properly trained prior to performing the activity. Remedy: Complete automation of the required training plans from employee onboarding to ongoing qualifiaction for employees engaged in GxP initiatives: Ensures the generation of consistent training records for the same courses, and consistent reporting and tracking. Enables employees to meet training goal requirements to perform operations or access systems. Ensures the right people are being trained on the right material at the right time. Managers and administrators are unable to clearly assess, map out, assign and report equivalent training conducted in multiple training methods/modalities. Gap: The existing LMS lacks the capability to track the training equivalencies between different learning activities, there is limited functionality available to address those equivalencies, and only the same training type/method can be made equivalent. For example, German and English versions of the same material can be made equivalent, but different types of learning sources fall outside this parameter. Therefore, an instructor-led training on an SOP and a read and sign training on the same SOP cannot be created as, or viewed as, equivalent in the LMS. Remedy: Training equivalency tracking between different learning sources: Reduces the omission of tracking records and human error related to manually handling employee training completions. System administrators can consolidate one master report for each type of training, making it easier to run reports and respond to audit inquiries and internal data requests. Page 5

6 Top Seven s to Consider When Selecting a Life Science LMS Pick Your Partner Wisely Quality and compliance are at the core of the Life Science learning system. It s always prudent therefore, to consider all qualified LMS vendors and not just those market leaders whose size and market penetration could mask their inefficiencies regarding critical compliance features. And it is these very features that can expose a Life Science organization to the most operational risks. Agile, more nimble providers have emerged who may actually have similar or superior capabilities in many areas than the big box providers. 1 Often, these companies demonstrate an advanced mastery of their craft vs. the Jack of all trades, master of none approach of their lumbering cousins. They might also possess a clear competitive advantage by offering greater capabilities, including unique system features and functionality, content, or special advisory services, in more areas common to your business. While many LMS programs available through leading providers are cutting edge, some are not built to support companies working in a regulated industry, while others cannot deliver the level of granularity needed to ensure that all quality and compliance training mandatories are met. To avoid these shortcomings, consider speaking with a provider that has worked successfully with organizations similar to yours, is nuanced within your industry, and is able to: Reflect a clear understanding of your business and the ability to work with you. Provide full disclosure on total service offerings and ensure maximum functionality. Provide your organization the ability to fully audit their system and operations. Ensure their system is easy for you to administer in-house. Remain flexible when developing solutions to fit users so they can leverage them. Partner with you in your transition or migration to the learning management space. References: 1. The Definitive Buyer s Guide to the Global Market for Learning Management Solutions 2014, Bersin by Deloitte, August Page 6

7 ComplianceWire COMPLIANCE MANAGEMENT FOR LIFE SCIENCE ORGANIZATIONS ComplianceWire UL EduNeering s validated, 21 CFR Part 11 cloud-based LMS was developed specifically for the training challenges faced by Life Science organizations and has been used to train over 36,000 FDA inspectors and investigators globally. ComplianceWire is deployed at over 250 Life Science clients across 67 countries, supporting 34 languages. For these reasons and more, 50% of the world s top Life Science organizations, as well as the FDA, have partnered with UL EduNeering to implement their quality and compliance learning solutions. To learn more about ComplianceWire, please call , Pat.Thunell@UL.com, or visit uleduneering.com. Page 7

8 About UL EduNeering UL EduNeering is a business line within UL Life & Health s Business Unit. UL is a premier global independent safety science company that has championed progress for 120 years. Its more than 10,000 professionals are guided by the UL mission to promote safe working and living environments for all people. UL EduNeering develops technology-driven solutions to help organizations mitigate risks, improve business performance and establish qualification and training programs through a proprietary, cloud-based platform, ComplianceWire. For more than 30 years, UL has served corporate and government customers in the Life Science, Health Care, Energy and Industrial sectors. Our global quality and compliance management approach integrates ComplianceWire, training content and advisory services, enabling clients to align learning strategies with their quality and compliance objectives. Since 1999, under a unique partnership with the FDA s Office of Regulatory Affairs (ORA), UL has provided the online training, documentation tracking and 21 CFR Part 11-validated platform for ORA-U, the FDA s virtual university. Additionally, UL maintains exclusive partnerships with leading regulatory and industry trade organizations, including AdvaMed, the Drug Information Association, the Personal Care Products Council and the Duke Clinical Research Institute. 202 Carnegie Center Suite 301 Princeton, NJ UL and the UL logo are trademarks of UL LLC uleduneering.com WP/15/063015/LS