Get 1 Month Free Trial on DMS & LMS |
Get 1 Month Free Trial on DMS & LMS |
KOŚA LMS is the learning management system for pharmaceutical & biotechnology industry teams that routes every GMP course, SOP read, and role-based curriculum through one configurable training engine — e-signed, effectiveness-checked, and audit-trailed for 21 CFR Part 11, EU GMP Annex 11, and GAMP 5.
PharmaCorp
BioGenex
MediLabs
CuraVita
NovaPharm
What you can achieve
Centralise document control and replace manual routing with configurable workflows. Reduce manual coordination across teams.
Designed to support FDA 21 CFR Part 11, EU GMP Annex 11 and ISO 13485 – keeping documentation inspection-ready at all times.
Monitor document activity, review backlogs and compliance KPIs in real time. Give QA leadership the visibility they need.
Go live in 6–8 weeks with structured implementation, training and 24/7 support – without disrupting existing operations.
One LMS. Everything your team needs
The pillars that come standard — no add-ons, no surprises.
Why a centralized LMS matters
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.
Compliance
GMP and GCP training expectations are enforced inside the workflow itself, not reconciled afterwards at audit time.
Integrity
Every assignment, read, quiz, and signature is captured under ALCOA++ principles, so the record holds up on its own in front of an inspector.
Traceability
A single audit trail follows each pharma training record from assignment through completion, re-issue, and retirement.
Risk
Overdue training, lapsed certifications, and unassessed curriculum changes are flagged while they’re still cheap to fix.
QA, regulatory, manufacturing, and lab staff train from the same effective course version in real time, wherever they sit.
Replaces the spreadsheets, sign-in sheets, and shared drives that training coordinators currently stitch together by hand.
What a pharma LMS covers
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.
Role-based curricula for lab, cleaning, and equipment SOPs
Structured first-90-days learning paths
Protocol, methodology, investigator training
21 CFR Part 11, data integrity, ALCOA++
URS, IQ / OQ / PQ competency sign-off
Impact-linked retraining assignments
Recertification & refresher scheduling
Management & SOP-authoring skills
Live dashboards expose completion rates and compliance metrics – exports produce audit-ready documentation for every review.
Capabilities
Capability pillars that come standard, no add-ons, no surprises.
Role-based course assignment, auto-enrolment & escalation.
Traceable read & understood, and quiz sign-off aligned to 21 CFR Part 11.
Personalised course paths & auto-generated change summaries.
The latest effective course version with full traceability.
Control access and assignment by role, site, or project.
Auto-compiled, exportable training records per employee.
Quizzes, competency checks & auto-issued certificates.
Full-text search across courses and training records.
Track completion, backlogs, and compliance status.
Regulatory frameworks
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.
Audit trails, access control & signature binding.
Including §211.25 personnel qualification & training requirements.
Medical device design & document history records.
GMP-regulated manufacturing and quality activities.
Personnel competence, awareness & training records.
Management for document repositories and access.
Personnel training & post-market requirements.
Risk management and pharmaceutical quality systems training.
Attributable, legible, contemporaneous, original, accurate.
Good documentation practice and data governance training.
Risk-based validation, including IQ / OQ / PQ training.
Investigator & site staff training for clinical trials.
Implementation
A phased, low-risk rollout designed around your validation package and audit calendar with 24/7 support from the first day.
Week 1–2
Document inventory, gap assessment and a structured cutover plan.
Week 3–4
Workflows, roles, templates and e-signature rules are configured to your SOPs.
Week 5-6
User acceptance testing alongside your validation package, ready for sign-off.
Week 7-8
Phased go-live with role-based training and 24/7 support from day one.
Get started
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
