LMS · Learning Management System
Empower Learning, Ensure Compliance
Streamline Pharma Product Training to all of your clients.
Automated & traceable
Centralise training assignment and replace spreadsheet tracking with role-based, automated curricula.
Confident compliance
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11, GAMP 5, and ISO 13485 training requirements.
Data-driven oversight
Monitor completion rates, overdue training, and competency KPIs across every site in real time.
Faster implementation
Go live in 6–8 weeks with structured curriculum migration, training, and 24/7 support.
One LMS. Everything your team needs
The pillars that come standard — no add-ons, no surprises.
Centralized Learning Hub
- Host and manage every course, SOP read, and certification in one configurable platform
- Supports e-learning modules, video training, live sessions, and blended learning
- Role-based dashboards give learners, managers, and administrators multilingual access from any site
AI-Powered Personalized Learning
- Adaptive learning paths tailored to each employee's role, site, and training history
- AI-driven recommendations surface the most relevant course next
- Keeps QA, manufacturing, and clinical teams continuously upskilled without manual curriculum building
Compliance-Ready Training
- Built-in workflows aligned to GCP, ICH, HIPAA, and 21 CFR Part 11
- Automated, e-signed audit trails for every training completion and certification
- Proof-of-training records ready to produce the moment an inspector asks
Certification & Competency Tracking
- Role-based certifications for site staff, trial teams, and employees
- Track skill development and validate competency across every function
- Automated recertification reminders keep compliance current, not overdue
Analytics & Insights
- Real-time dashboards track engagement, completion, and overdue training
- AI-driven analytics flag knowledge gaps before they become audit findings
- Compliance-ready reports generated on demand for regulators and auditors
The case for one controlled system, not six spreadsheets.
An electronic learning management system for the pharmaceutical industry is critical to compliance, quality, and safety. Companies that meticulously assign, track, and document training mitigate risk and maintain the highest quality standards across drug development and production.
Regulatory compliance, by default
GMP and GCP training expectations are enforced inside the workflow itself, not reconciled afterwards at audit time.
Data integrity you can stand behind
Every assignment, read, quiz, and signature is captured under ALCOA++ principles, so the record holds up on its own in front of an inspector.
One immutable trail, start to finish
A single audit trail follows each pharma training record from assignment through completion, re-issue, and retirement.
Risk surfaced early, not at inspection
Overdue training, lapsed certifications, and unassessed curriculum changes are flagged while they're still cheap to fix.
One controlled curriculum, every team
QA, regulatory, manufacturing, and lab staff train from the same effective course version in real time, wherever they sit.
A centralised repository
Replaces the spreadsheets, sign-in sheets, and shared drives that training coordinators currently stitch together by hand.
Built for the training regulators actually ask for.
From induction to advanced competency, every stage of the pharmaceutical learning management system produces a controlled training record. KOŚA pharmaceutical LMS software is built around the courses and records that matter most during an inspection.
GMP/GDP & SOP Training
Role-based curricula for lab, cleaning, and equipment SOPs
New Hire Onboarding & Induction
Structured first-90-days learning paths
Clinical Trial & GCP Training
Protocol, methodology, investigator training
Regulatory & Compliance Courses
21 CFR Part 11, data integrity, ALCOA++
Equipment & Process Qualification
URS, IQ / OQ / PQ competency sign-off
Change Control & CAPA Training
Impact-linked retraining assignments
Periodic Competency Reassessment
Recertification & refresher scheduling
Leadership & Cross-Functional Development
Management & SOP-authoring skills
Real-time visibility into every learner.
Live dashboards expose completion rates and compliance metrics, and exports produce audit-ready documentation for every review.
- Live dashboards for completion, overdue training, and competency gaps
- Audit-ready training evidence packs exported on demand
- Custom reports for management review
- Compliance KPIs tracked across every site
Everything you need to run a controlled training system.
Capability pillars that come standard, no add-ons, no surprises.
Automated Curricula
Role-based course assignment, auto-enrolment & escalation.
Electronic Signatures
Traceable read & understood, and quiz sign-off aligned to 21 CFR Part 11.
AI-Powered Recommendations
Personalised course paths & auto-generated change summaries.
Version Control & History
The latest effective course version with full traceability.
Role-Based Access Control
Control access and assignment by role, site, or project.
Individual Training Files
Auto-compiled, exportable training records per employee.
Assessments & Certification
Quizzes, competency checks & auto-issued certificates.
Search, Filtering & Navigation
Full-text search across courses and training records.
Reporting & Analytics
Track completion, backlogs, and compliance status.
Built as the electronic learning management system for pharmaceutical industry teams, not a spreadsheet patch.
KOŚA learning management system for the pharmaceutical industry helps you implement training processes that maintain traceability, controlled assignment, and documented oversight across the entire learning lifecycle.
Electronic Records & Signatures
Audit trails, access control, and signature binding.
cGMP Documentation
Including §211.25 personnel qualification & training requirements.
Quality System Regulation
Medical device personnel training & document history records.
Computerised Systems
GMP-regulated training and quality activities.
Medical Device QMS
Personnel competence, awareness & training records.
Information Security
Management for training data and access.
Device Documentation
Personnel training & post-market requirements.
Quality Risk & Systems
Risk management and pharmaceutical quality systems training.
Data Integrity Principles
Attributable, legible, contemporaneous, original, accurate.
Data Integrity
Good documentation practice and data governance training.
Validation
Risk-based validation, including IQ / OQ / PQ training.
Good Clinical Practice
Investigator & site staff training for clinical trials.
Go live in 6–8 weeks, without disrupting current operations.
A phased, low-risk rollout designed around your validation package and audit calendar with 24/7 support from the first day.
Week 1–2
Discovery & migration plan
Document inventory, gap assessment and a structured cutover plan.
Week 3–4
Configuration & workflow build
Workflows, roles, templates and e-signature rules are configured to your SOPs.
Week 5–6
Validation & UAT
User acceptance testing alongside your validation package, ready for sign-off.
Week 7–8
Go-live & training
Phased go-live with role-based training and 24/7 support from day one.
See KOŚA LMS in your environment.
Book a 30-minute walkthrough with a compliance architect, tailored to your curricula, your roles, and your audit calendar.
21 CFR Part 11 · EU Annex 11 · ALCOA++ · GAMP 5