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