Patni implemented a new global LIMS to support products transferred as part of corporate divestment and the migration of historical data for sold product lines.

The Client
The Client is a world's leading consumer health company, engaged in the R&D, manufacture and sale of consumer health care products, pharmaceuticals and medical devices and diagnostics.

The Challenge
Client required assistance in the design, development, implementation and post deployment support of a global LIMS as a result of an acquisition. The new LIMS system was required to support testing of finished products, raw materials,research and development, and stability study samples across five geographies and had to support manufacturing plants in the US, Canada, and Europe.
For compliance and business purposes, it was necessary to migrate all product laboratory test data to the new LIMS.

The Solution

• Patni designed and implemented single instance of Global LIMS in five R&D sites, including a one-time data migration activity to move lab results from three legacy systems to the new Global LIMS.

Four phases of the solution were:
Implementation

• Configure & customize LabWare pharma template
• System build
• Establish change management process

Data Migration

• Migration of stability data from legacy systems to the new Global LIMS
• Warehouse all completed studies from legacy systems
• Write Crystal reports to access these reports

Validation

• Risk based approach to validation
• Author all validation plans, protocols and reports
• Facilitate execution of validation test scripts
• Validate and verify data migrated
• Author Global system SOPs

Empower Upgrade Validation

• Standard COTS validation package developed for Empower and included
• Validation plan
• FRS and SDS
• IQ protocol, scripts, summary and final validation reports

Patni executed a risk-based approach to validate configured LabWare LIMS and collaborated with the client to provide business context and application-specific training. The new LIMS is now in routine use at all locations to record and report all laboratory testing and manage instrument calibration program.
In a follow up project, an interface was developed to allow the LIMS to receive updated product specification information from the document management system.

The Benefits
The Client experienced a smooth transition from the old system to the new implemented system. Key benefits are:

• Achieved significant business process improvement by designing the system with the flexibility to accommodate current and future needs at all sites.
• Reduced the cost of Master Data Management (MDM) process by 25% and increased site lab and QA business capacity by freeing half the resources from MDM responsibilities.
• Provided a higher level of business process integration by leveraging the document management system interface.
• Completed personnel assignment and training completed in five weeks.

The Technology

• LabWare LIMS
• Waters Empower CDS
• Agilent Open LAB ECM/DA
• Beckman 8.4a
• Beckman 9.3
• Sample Manager