Standardizing Quality Control Across a National CDMO Network: Akums Drugs & Pharmaceuticals and OasisLIMS
How India's largest Contract Development and Manufacturing Organization brought multi-site laboratory operations onto a single, 21 CFR Part 11-compliant OasisLIMS platform, integrated with SAP and its document management system.
Client Overview
Akums Drugs & Pharmaceuticals Limited is one of India's largest Contract Development and Manufacturing Organizations (CDMOs), with a business spanning finished-dose formulations and active pharmaceutical ingredient (API) manufacturing for domestic and global pharmaceutical brands. Headquartered in Haridwar, Uttarakhand, the company operates a network of manufacturing and testing sites across India, including a dedicated R&D division and a commercial testing laboratory.
As Akums' CDMO business scaled, its laboratories needed a common quality-control backbone: one platform that could standardize testing workflows across every site, satisfy the regulatory expectations of global pharmaceutical clients, and connect laboratory data directly into the company's enterprise systems.
The Challenge
Running quality control for a CDMO of Akums' scale means every site has to perform to the same standard — because the client audits, regulatory inspections, and product release decisions all depend on it. Ahead of implementing OasisLIMS, Akums faced three connected pressures:
- Manual, site-by-site processes: laboratory workflows had grown up independently at each facility, with testing, sample logging, and reporting handled through largely manual and paper-based methods that limited throughput and made it difficult to scale CDMO volumes consistently.
- Traceability and data integrity gaps: without a unified electronic system, results relied heavily on manual transcription and paper records, leaving limited audit trails and no consistent, defensible chain of custody from sample receipt through final release.
- Regulatory compliance and multi-site standardization: as a CDMO serving global pharmaceutical clients, Akums needed every site — R&D, commercial testing, and manufacturing labs alike — to operate on validated, 21 CFR Part 11-compliant electronic records and signatures, with workflows standardized enough to support a consistent validation approach across the network.
Underpinning all three was an integration gap: laboratory data lived apart from Akums' SAP ERP environment and its document management system, which meant inventory, inspection, and quality documentation had to be reconciled manually rather than flowing automatically between systems.
The OasisLIMS Solution
Oasis Infotech deployed OasisLIMS 4.5 as the common laboratory platform across Akums' network, configured to standardize core quality workflows while integrating directly with the company's enterprise systems.
Unified Sample and Quality Workflows
Sample Management gives every site a consistent, electronic path from sample login through testing, review, and release — replacing manual, paper-based tracking with a standardized workflow usable across every facility. A Stability Studies module manages stability protocols, pull schedules, and results reporting, giving R&D and quality teams a structured way to track long-running studies across sites. Reference/Standard Management and Lab Inventory Management modules track reference standards, reagents, and chemical stock levels, tying consumption and reordering directly to laboratory activity.
Compliance Built for Global Pharmaceutical Clients
Role-based access, secure electronic signatures, and full audit trails were configured to meet 21 CFR Part 11 requirements for electronic records and signatures. The deployment was validated using a GAMP 4-based approach, with IQ/OQ/PQ documentation covering core LIMS functionality and the add-on modules, giving Akums audit-ready evidence for both internal and client-driven inspections.
Connected Enterprise Systems
A bidirectional SAP integration links Sample Management to material master data, inspection lots, and inventory adjustments, so quality and supply-chain data stay synchronized without duplicate entry. Integration with Akums' document management system (DMS) connects controlled quality documents — methods, specifications, and SOPs — directly to the laboratory workflows that depend on them, keeping test execution aligned to the current approved version.
Rollout was phased, beginning with a pilot site before extending across the remaining manufacturing, R&D, and commercial testing locations, with role-based training designed separately for lab analysts, QA teams, and IT staff.
Business Impact
- Standardized operations: a common LIMS configuration across sites gives Akums a consistent quality-control process regardless of location, simplifying oversight for a CDMO business built on serving multiple global clients from multiple facilities.
- Stronger audit readiness: role-based approvals, electronic signatures, and complete audit trails give Akums a defensible, 21 CFR Part 11-aligned record set for both regulatory inspections and client audits.
- Reduced manual reconciliation: SAP and DMS integration mean inventory, inspection, and document-control data now flow directly between systems, cutting the manual cross-checking that previously sat between the lab and the back office.
- Scalable foundation: the modular add-on approach — trend analysis, stability, inventory, reference standards — lets Akums extend the platform to new sites or capabilities without redesigning the core system each time.
“OasisLIMS gave us a way to bring every site onto the same page — the same workflows, the same compliance standard, the same visibility into our data. That consistency is exactly what our clients expect from a CDMO partner our size.”
Quality Assurance & IT Leadership, Akums Drugs & Pharmaceuticals Limited