Wednesday, August 11, 2010

Augmenting PLM system as a LMS in FDA regulated companies

Learning Management Systems

Most of us have used a LMS system sometime or the other. Broadly “A learning management system (commonly abbreviated as LMS) is a software application for the administration, documentation, tracking, and reporting of training programs, classroom and online events, e-learning programs, and training content.”
Modern web based LMS’s usually have certain key characteristics like: Computer-Based training, Training workflow (e.g., user notification, manager approval, etc), On-line assessment, Collaborative learning (e.g., application sharing, discussion threads), and Training Resource Management (e.g., manage users, roles, courses, instructors, facilities, and generate reports, high-level executive dashboards). Some LMS companies are also venturing out into the SaaS and M-Learning (PDA’s etc) space.

In an enterprise, an LMS can expand its clout when it's coupled with existing Document Management System, Human Resource Information System (HRIS), Talent management systems and possibly Access Control Systems in a regulated manufacturing facility.

Compliance Management for the FDA-Regulated Organization

In FDA-Regulated organizations, LMS system’s supports the quality and validation constructs determined by Good Automated Manufacturing Practices (GAMPs) and GxPs. Such systems usually enables companies to manage the distribution of SOP’s - Standard operating procedures, corporate policies, forms, surveys and regular communications with acknowledged electronic receipt and tracking to employees, suppliers and contractors. Quizzes can be produced and associated to SOPs and vital documents, which can then test understanding of the material. Such systems also place a great deal of focus on Electronic signatures and records, Audit logs etc. to comply with 21 CFR part 11 requirements.

Can a PLM system be enhanced to work as a LMS?

“A learning content management system (LCMS) is a related technology to the learning management system, in that it is focused on the development, management and publishing of the content that will typically be delivered via an LMS. An LCMS is a multi-user environment where developers may create, store, reuse, manage, and deliver digital learning content from a central object repository.”
Many life sciences organizations already use their existing PLM system as a LCMS (for SOP’s policies etc.). Also a PLM system already takes care of features which a LMS system provides such as versioning, data security, storage and distribution of documents and auditable record of all activity associated with them, history of end user activity, change control, manage users, roles, and 21 CFR part 11 requirements.

As noted in the paper “Trends in LMS” by Don McIntosh, Ph.D. prices of LMSs vary widely from as low as USD 5,000 to several hundred thousand dollars depending on the features they offer and the number of people using them. Some of the simplest LMSs just provide a platform for launching and tracking e-learning. While there are a bunch of open source LMS systems out there (for more reading see “Open Source LMS – 10 Alternatives to Moodle by Barry Sampson”) if you want your PLM system to take care of your training needs as well then with a bit of customization (example: to build your own electronic quizzes and exams), it can surely be extended to take care of such needs. Leveraging a single platform to take care of multiple needs increases your ROI.

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    Document Management Systems


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