Automate GMP, GCP, GDP, and GLP training records across manufacturing sites. AlphaLearn ensures every employee is trained, documented, and audit-ready - with 21 CFR Part 11 and CDSCO alignment.
Trusted by 500,000+ learners at India's leading enterprises
Pharmaceutical and life sciences companies operate under some of the most rigorous training documentation requirements in the world. Non-compliance is not just a commercial risk - it can result in product recalls and manufacturing shutdowns.
WHO-GMP, US FDA 21 CFR Part 211, and EU GMP Annex 11 all require training records to be maintained, version-controlled, and retrievable on demand. Paper-based SOP acknowledgement is no longer sufficient for modern regulatory inspections.
When a manufacturing SOP is revised, every employee who works under that SOP must be retrained and re-assessed before they can continue the task. Without an automated system, tracking this across shifts is chaotic.
Pharma companies with plants across multiple states need identical training delivered identically at every location. Instructor-led classroom training introduces content variation that cannot be controlled.
Validated training management for pharmaceutical manufacturing, QA, regulatory affairs, and clinical operations.
Link each training module directly to a specific SOP version. When an SOP is revised, AlphaLearn automatically triggers retraining for all employees in the affected role group. Completion is tracked before production work resumes.
Electronic training records with audit trail, timestamped e-signatures, and version control. All records are immutable once signed - meeting FDA and MHRA electronic records requirements.
One central system managing training at all manufacturing sites. Site-specific curricula can be configured independently while compliance reporting is aggregated centrally for QA and regulatory affairs teams.
Set training validity periods for each module. AlphaLearn automatically triggers refresher training before a qualification expires and flags employees whose qualifications are lapsing.
Generate the training matrix in seconds for any WHO-GMP, US FDA, or CDSCO inspection. Filter by site, department, role, SOP, or date range. Export as PDF or Excel.
Shopfloor workers across Indian manufacturing sites can access GMP and safety training in Hindi, Gujarati, Marathi, Tamil, Telugu, and 7 other Indian languages. Comprehension assessments are conducted in the same language.
Pre-built course templates and structured learning paths designed for your industry.
Core GMP principles covering documentation, contamination control, deviation management, and cGMP culture. Available in 12 Indian languages for shopfloor workers.
Role-specific SOP modules with comprehension quizzes. Employees must score above the pass mark before they can sign off on a procedure. Scores are logged against each SOP version.
ICH E6(R2) GCP training for clinical research associates, site coordinators, and investigator site staff. Includes scenario-based assessments aligned with CDSCO requirements.
Training modules linked to equipment qualification (IQ/OQ/PQ) protocols. Operators must complete equipment-specific training before being authorised to operate validated equipment.
Training on adverse event reporting, CDSCO Schedule M requirements, and pharmacovigilance SOPs. Auto-enrolment for all regulatory affairs and medical affairs staff.
Scheduled refresher courses for all GMP-qualified staff. Refreshers trigger automatically based on the last completion date and role-specific validity periods.
Real results. Real ROI. From teams just like yours.
WonderChef has seen a substantial reduction in employee training costs after switching to AlphaLearn. Training became consistent and personalised - empowering employees with the tools to achieve organisational goals.
AlphaLearn replaced classroom training entirely at KIMS Hospitals. We saw a 60% reduction in training travel costs and the senior management can now easily measure ROI.
Sharekhan Education received tremendous response on ease of use. Learners love the self-paced format - virtual sessions, surveys, quizzes, and recordings all in one place.
Everything you need to know about AlphaLearn for Pharmaceutical
Yes. AlphaLearn supports 21 CFR Part 11 and EU GMP Annex 11 requirements including electronic signatures with timestamp, immutable audit trails for all record modifications, version-controlled training records, and controlled access by role. Training completion records cannot be altered after sign-off, and the full audit trail is accessible for any inspection.
AlphaLearn integrates with document management workflows. When a new SOP version is published, the platform auto-generates a retraining assignment for all employees whose role is linked to that SOP. Employees are notified via email and mobile app. Until retraining is completed and assessed, the employee's qualification flag shows as lapsed in the training matrix.
Yes. AlphaLearn supports multi-site configurations where each manufacturing site can have its own curriculum, role structure, and SOP library while sharing a central compliance reporting dashboard. Site administrators manage their own learner groups; corporate QA and regulatory affairs see consolidated training metrics across all sites.
Yes. AlphaLearn supports 12 Indian languages including Hindi, Gujarati, Marathi, Tamil, Telugu, Kannada, and Bengali. GMP training modules, safety procedures, and equipment SOPs can be delivered in the worker's preferred language. Comprehension assessments are also conducted in the same language. This significantly improves shopfloor GMP compliance rates.
AlphaLearn includes a library of pre-built modules covering GMP foundation (cGMP principles, documentation, deviation management), GCP (ICH E6 R2), pharmacovigilance, POSH, and safety. Customers can also import SCORM packages from authoring tools like Articulate Storyline, iSpring, or Adobe Captivate, or build new modules using the AI-powered course creator.
Book a personalised demo and see AlphaLearn configured for your industry in 30 minutes.
