Today, research firm Brandon Hall presented the results of their Excellence in Learning Technology Awards which aims to recognize the best in commercial learning technology.
Cobent was awarded the Bronze Award for Best Advance in Learning Management Technology for Compliance Training. Today's award categories spanned learning management, content management, synchronous learning, analytics, 3-D, social media and performance support.
The judging process was based on system functionality, usability and overall features and pluses. The Cobent LMS for compliance training, 'Learning Compliance Suite' (LCS), provides a framework using best practices for managing compliance procedures and training in business environments that are subject to regulatory audits. This includes powerful features that provide the ability for company administrators to not only automate training in centralized or decentralized training groups but also to:
Create, deliver and update content through version controlled workflows
Automate and alert the re-assignment of all revised content such as documents or e-learning
Create blended learning paths that can enforce multiple e-signature captures and on-the-job tracking
Measure competency against training activities to track qualification of users by role
Ensure audit-readiness compliant with the FDA's 21 CFR Part 11 guidance for data security and auditability
While some of these features are used in traditional employee learning management environments, Cobent was an early pioneer in developing and applying these principles to businesses and industries that face heavy regulation and exposure to risk due to non-compliance.
Cobent is pleased to accept the Brandon Hall bronze award for the LMS compliance training category. We plan to release new products in the coming months that providing a deeper dive into compliance management and help our clients best manage compliance initiatives efficiently and cost-effectively.
Look out for the official press release announcing today's win soon!
Training deficiencies were noted in 30 percent of the 97 device quality system warning letters released by FDA in 2008, up from 22 percent the year before. The FDA has also started enforcing key requirements of Part 11 issues, previously limited to inspector discretion. In the last 3 years, the FDA issued over 30 Part 11 warning letters. Will this trend continue? Does training matter?
Training deficiencies observed by most frequent occurrence often point to training not documented, lack of training, lack of training procedures and insufficient personnel. Yet the regulations for training clearly spell out the requirements:
Title 21 CFR 820.25 - Personnel. (a) General. Each manufacturer shall have sufficient personnel with the necessary education, background, training, and experience to assure that all activities required by this part are correctly performed.
Title 21 CFR 820.25 - Training. (b) Each manufacturer shall establish procedures for identifying training needs and ensure that all personnel are trained to adequately perform their assigned responsibilities. Training shall be documented.
Add to the challenges of training to 820.25 regulations, the duality of ensuring 21 CFR Part 11 compliance. Does Part 11 compliance for validation, security, e-signatures and audit trails apply to training? Indeed it does.
How do you manage training and compliance for your GxP environments? Are paper-based systems still being used? While paper systems are perfectly acceptable to auditors and inspectors, they may prove time and cost intensive to the business. FDA regulated companies have long since understood the benefits of using electronic training tracking systems, however, many have not made the full leap to one or may be still operating hybrid (paper and electronic) systems.
View a recorded demonstration of Cobent's 'Learning Compliance Suite' (LCS), FDA Regulated Recorded Demo here. See first hand how LCS automates and simplifies compliance training for FDA and GxP compliance environments.