From Paper to Platform: How Intas Pharmaceuticals' F&D Lab Modernized R&D with OasisLIMS RD Solution
A Formulation & Development laboratory replaces manual worksheets and disconnected tracking with a single, traceable, 21 CFR Part 11-ready platform for sample, project, and stability management.
Client Overview
Intas Pharmaceuticals Ltd is a major India-based pharmaceutical manufacturer with a wide portfolio spanning formulations and active pharmaceutical ingredients, headquartered in Ahmedabad, Gujarat, with development and manufacturing operations at multiple sites across India.
Within Intas, the Formulation & Development (F&D) R&D laboratory sits at the center of new product development — running trials, stability studies, and dissolution profiling that ultimately feed technology transfer, regulatory submissions, and manufacturing scale-up. As the lab's trial volume and product pipeline grew, its reliance on manual, paper-based methods increasingly stood in the way of the speed and data integrity that R&D and regulatory teams needed.
The Challenge
Formulation & Development labs sit under some of the tightest scrutiny in the pharmaceutical value chain: every trial, worksheet, and stability pull eventually has to stand up to regulatory review. Ahead of implementing OasisLIMS RD Solution, Intas' F&D lab was working against four connected sets of constraints:
- Manual, paper-driven operations: sample registration, worksheets, calculations, and reporting were largely handled on paper or in disconnected spreadsheets, slowing test assignment and approvals and leaving the lab with poor visibility into workflow status and resource workload.
- Traceability and data integrity gaps: manual transcription introduced data-entry errors, historical results were difficult to retrieve, and audit trails were too weak to fully satisfy 21 CFR Part 11 and ALCOA+ expectations — turning audit preparation into a time-consuming, reactive exercise.
- Operational blind spots: missed instrument calibration and maintenance schedules, inconsistent method and document version control, and limited inventory management of chemicals and reference standards added risk and rework across ongoing trials and stability studies.
- Limited visibility and collaboration: without real-time project monitoring or management dashboards, R&D, QA, QC, and Manufacturing teams had limited shared visibility into project status, trend data, or COA turnaround — slowing decision-making and extending overall laboratory turnaround time (TAT).
Together, these gaps translated into higher operational cost, added risk of data loss or unauthorized access, and a laboratory that was working harder than it needed to in order to keep pace with Intas' product development pipeline.
The OasisLIMS Solution
Oasis Infotech deployed OasisLIMS RD Solution — a configuration of the OasisLIMS platform purpose-built for Formulation & Development laboratories — to bring Intas' F&D lab onto a single, connected system spanning trial management through stability and reporting.
End-to-End Sample and Project Management
Sample Management replaces manual registration and tracking with an electronic, traceable workflow from intake through disposition. Project Management and Gantt Chart views give R&D leadership real-time visibility into trial timelines, milestones, and workload across the F&D pipeline, replacing status updates that previously relied on manual follow-up. Trial Summary and Product Formula modules centralize formulation data and trial history, making it possible to retrieve historical results and compare trials without digging through paper files.
Structured Studies and Worksheets
Stability Studies and Dissolution Profiling modules manage protocols, pull schedules, and results capture for two of the most data-intensive activities in F&D work. Group Worksheets standardize calculations and reporting formats across analysts, reducing the manual-calculation errors that previously crept into results and reports.
Compliance and Enterprise Connectivity
Role-based access, electronic signatures, and complete audit trails were configured in line with 21 CFR Part 11 and ALCOA+ data-integrity principles, giving the lab a defensible record from raw data through final report. Integration with the lab's analytical instruments enables direct, automated data capture, while connectivity to ERP, DMS, and ELN systems keeps formulation, document-control, and enterprise data aligned with lab activity rather than reconciled after the fact.
Business Impact
- Faster trial throughput: automated sample registration, worksheets, and calculations reduce the manual steps between trial execution and reportable results, shortening lab turnaround time.
- Stronger data integrity and audit readiness: complete audit trails and electronic signatures give the lab a 21 CFR Part 11/ALCOA+-aligned record set, cutting the time spent preparing for audits and inspections.
- Improved cross-functional visibility: real-time dashboards and project tracking give R&D, QA, QC, and Manufacturing a shared view of trial status and trends, improving coordination on technology transfer and regulatory timelines.
- Reduced operational risk: proactive calibration/maintenance tracking and standardized inventory management for chemicals and reference standards reduce the risk of missed schedules or stockouts disrupting active trials.
“Our F&D team used to lose real time chasing paper worksheets and reconstructing trial history. Moving onto OasisLIMS RD Solution gave us one place to see every trial, every stability pull, and every approval — and that visibility has changed how quickly we can move a formulation forward.”
Formulation & Development Lab Leadership, Intas Pharmaceuticals Ltd