CLEEN Go-Live at Alkem
Alkem Laboratories goes live with Leucine's CLEEN — Cleaning Validation Software across their Daman and Baddi manufacturing facilities.
“One of the fastest implementations at a new logo, covering multiple facilities and additional CSV at the client end. A testament to unwavering collaboration, speed, and focus from both the Leucine and Alkem teams.”
Leucine
CLEEN Go-Live at Alkem Laboratories, 2025
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About the Event
Alkem Laboratories, one of India's leading pharmaceutical companies with 18 manufacturing facilities and regulatory approvals from the USFDA, MHRA, TGA, ANVISA, and WHO, went live with Leucine's CLEEN — Cleaning Validation Software across their Daman and Baddi facilities on July 25, 2025.
This was one of the fastest multi-site CLEEN implementations at a new customer. The deployment covered multiple manufacturing facilities simultaneously, with additional computer system validation (CSV) completed at the client end — digitising Alkem's entire cleaning validation lifecycle from protocol design to regulatory reporting.
The go-live event brought together the Alkem and Leucine teams for a celebration that included a CLEEN Go-Live presentation, a cake-cutting ceremony, and a group photo marking the milestone.
Key Themes
- ↪ HBEL-based residue limit calculations with full traceability
- ↪ Real-time validation status tracking for all equipment
- ↪ Accelerated new drug introduction through instant risk assessments
- ↪ Regulatory-compliant risk-driven procedures and audit readiness
CLEEN
Product Deployed
2
Facilities (Daman & Baddi)
Fastest
Multi-Site New Logo Deploy
Day 1
Audit-Ready
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Leucine &
the Go-Live
Leucine partnered with Alkem's quality and validation teams to deploy CLEEN across two manufacturing facilities simultaneously — Daman and Baddi — replacing manual cleaning validation workflows with a fully digital, compliance-ready platform.
The implementation was notable for its speed. Covering multiple facilities at a new customer with full computer system validation, the Leucine team fast-tracked the deployment while maintaining complete regulatory compliance and audit readiness from day one.
The go-live ceremony at Alkem brought both teams together to celebrate the milestone — with a CLEEN Go-Live presentation, the teams cutting a branded celebration cake, and a group photo capturing the combined Leucine and Alkem implementation teams.
What We Showcased
CLEEN
Automated cleaning validation with HBEL calculations, worst-case matrix generation, and protocol auto-generation across both Daman and Baddi facilities.
Multi-Site Deployment
Simultaneous go-live across two manufacturing facilities with harmonised validation protocols.
Computer System Validation
Full CSV completed at the client end, ensuring 21 CFR Part 11 compliance from day one.
Risk Assessments
Instant risk assessments to accelerate new drug introduction and product changeovers across both sites.
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Leucine CLEEN
The cleaning validation platform that powers Alkem's digital cleaning validation lifecycle across Daman and Baddi — from HBEL-based residue calculations and worst-case matrix generation to real-time equipment validation tracking and audit-ready documentation.
Explore Leucine CLEEN03 /
Key Takeaways
Alkem's Daman and Baddi facilities now run a fully digital cleaning validation lifecycle — from protocol design to regulatory reporting — with zero manual calculations.
Multi-site deployment was completed simultaneously, harmonising cleaning validation protocols across both manufacturing locations.
The implementation was one of the fastest at a new customer, demonstrating that CLEEN can be deployed rapidly without compromising on validation rigour or regulatory compliance.
Full computer system validation was completed at the client end, ensuring 21 CFR Part 11 compliance and audit readiness from the first day of production use.
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Photos
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See It
in Action
Interested in what Leucine demonstrated at Alkem Laboratories Goes Live with CLEEN at Daman & Baddi? Our team can walk you through the platform and discuss how it applies to your manufacturing operations.