Key questions to ask your LMS vendor - LIFE SCIENCES
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Learning in the workplace is changing While traditional companies may still rely primarily on instructor-led training, future-forward organizations are finding new, efficient ways to deliver just-in-time training. Learning management systems (LMS) are the key to delivering interactive methods of mobile learning, and can offer the added advantage of integrating with talent management goals. For life sciences organizations, an LMS can also address the critical need of facilitating 21 CFR Part 11compliance. While finding an LMS vendor with basic capabilities is fairly simple, partnering with a provider that understands the FDA mandate for electronic records authenticity takes asking the right questions – and getting the right answers. LIFE SCIENCES
What key questions should your life sciences organization be asking LMS providers to ensure your ability to meet 21 CFR Part 11 compliance? LIFE SCIENCES
Catalog management: considerations for effective content and compliance What options are available for structuring our Can the LMS manage our catalog? Is it flexible enough to meet the needs of versioning system simply both our GxP and non GxP groups? and without significant manual interventions? Catalog management forms the foundation of your organization’s ability to deliver courses quickly and Simplified version control is efficiently and track course completion for compliance. key to avoid extensive hands- An LMS that has an architecture that is already similar on interaction every time a to your existing catalog structure will reduce time course changes. spent manually making adjustments to the system. LIFE SCIENCES
How are courses delivered? Is there Will we be able to assign training mobile capability? Will we be able based on job code or location? Can to observe performance in the field the system alert us to recertification without being tied to a laptop? Is there needs and track GxP credits? access to training without Internet or in areas of restricted bandwidth? Create test scenarios to ensure the LMS is capable of automatically An LMS with mobile capabilities can assigning training to the right people facilitate real time observation; offline at the right time, and notifying capabilities enable training delivery in those individuals of these training the field when Internet access is limited requirements. Confirm that the system or unavailable. can inform you, without significant manual effort, who needs to be certified or recertified or who needs to complete a particular course. LIFE SCIENCES
Auditing capabilities: assess appropriate data for quality audit trails What data points need to be audited How can we access an audit trail? for each field? If the audit trail is for a specific course Do you need a user name? Or a first and and is pertinent to people at a specific last name? Will you need a date stamp and/ location or job site, can these results be or a time stamp? These details need to be filtered easily? Will you have to spend addressed prior to choosing an LMS to significant time manually combing ensure your expectations will be met. It’s also through reports to find the data you important to discover if there are workarounds need, or can the system quickly run a if certain data points aren’t available. customized report? LIFE SCIENCES
Change process: evaluate documentation quality & configuration abilities What is contained in release Can functionality be How might documentation? enabled and disabled? configuration change in any given release? How easy will it be to During a new release or understand any changes interim fixes, it’s critical to be Are new configurations in functionality? How able configure functionality at anticipated to be easy comprehensive is the vendor’s your own pace. The ability to to implement and documentation? The ability to enable and disable features understand or will you anticipate the change process ensures you can control new need a dedicated team and changes in functionality functionality on your time to manage the changes? will minimize the validation schedule, when you know process when your vendor you have access to adequate releases a new version. resources and training. LIFE SCIENCES
Reporting and data retrieval: evaluate reporting & ease of information integration Are compliance/noncompliance reports What level of report security configured in a way that meets our is available? organization’s requirements? Most organizations need to limit To minimize manual manipulation, compliance access to reporting to ensure each reports should be generated in a manner most department receives only the data similar to your organization’s existing structure. pertinent to their group. LIFE SCIENCES
Can we filter data Are reports configurable? Does the system allow for in all reports? Can the system handle ad external database access? hoc requests? Comprehensive filtering To be most effective, the capabilities allow you to The capability to configure LMS should be able to appropriately limit the reports ensures your leverage data not already data you deliver to the organization can meet all in the system. FDA during an audit. reporting requirements in the future. Cornerstone OnDemand is a leader in cloud-based applications for talent management. Our solutions help organizations recruit, train, manage and connect their employees, empowering their people and increasing workforce productivity. Learn more at csod.com/lifesciences. ©2014 Cornerstone OnDemand, Inc. Created in collaboration with LIFE SCIENCES csod-industry-brief-lifesciences-2014
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