LMS Explained: How Quality Teams Go From Training Gaps to Audit-Ready Evidence

A learning management system, or LMS, is software that assigns, delivers, and records training so a regulated company can prove who was trained on what, and when. Quality organizations do not get audited on effort. They get audited on evidence. This video follows one revised procedure from approval to CAPA closure and shows what an LMS must prove in a regulated company: the right person, the right version, the right time. Free tools Free LMS selection scorecard toolkit (Word): https://www.eleapsoftware.com/whitepa... Learn more: https://www.eleapsoftware.com/how-to-... See eLeaP's LMS and QMS in a live demo: https://www.eleapsoftware.com/meet-ou... Chapters 0:00 The investigator's question 0:48 What an LMS is in a regulated company 2:25 One revised procedure, six steps 4:46 Manual records versus a connected trail 5:47 Five capabilities that matter 7:35 Seven questions for choosing an LMS 10:41 AI in an LMS: assistance versus decisions 11:34 Your next step In this video What an LMS holds in a regulated company, and why course delivery is only one function How Revision C of an incoming inspection procedure moves through intake, assignment, verified completion, an effectiveness check, CAPA closure review and one linked trail Manual training records compared with a connected system Five capabilities to look for: controlled curricula, role-based assignment and e-signatures, verification before record closure, traceability, and dashboards Seven questions to bring to a vendor demo: regulatory fit, process fit, evidence and ALCOA+, adoption, data model and integration, validation and audit trails, and phased value Where AI belongs in an LMS, and where a named reviewer has to sign Who is this for Quality and regulatory leaders, training and compliance managers, QA and RA practitioners, operations leaders, and IT and validation teams in medical device, pharmaceutical, biotech, automotive, aerospace and general manufacturing organizations. The same evidence questions apply in other regulated industries, including financial services. Regulations and Guidance 21 CFR Part 11 (electronic records and signatures): https://www.ecfr.gov/current/title-21... QMSR, FDA Quality Management System Regulation: https://www.fda.gov/medical-devices/p... ISO 13485:2016 (medical device QMS): https://www.iso.org/standard/59752.html 21 CFR 211.25 (personnel qualifications): https://www.ecfr.gov/current/title-21... MHRA GxP data integrity guidance (ALCOA+): https://www.gov.uk/government/publica... About eLeaP's LMS eLeaP's LMS covers the training lifecycle: course authoring in a built-in editor, SCORM import, PowerPoint conversion, learning paths, skills tracked by percentage or by level, observation checklists, instructor-led sessions with registration and attendance, and credential tracking for licenses and continuing education. It runs as one platform with the eLeaP QMS, so documents, training, change control, events and CAPA, audits, risk, design controls, suppliers, and the audit trail stay linked together. Learn more about eLeaP's LMS: https://www.eleapsoftware.com/compreh... Learn more about the eLeaP QMS: https://quality.eleapsoftware.com/qua... #LMS #QualityManagement #TrainingCompliance #AuditReadiness #CAPA #21CFRPart11 #ISO13485 #eQMS