ATS Global Implements Laboratory Information Management System for a Leading Pharmaceutical Company in India

Purpose

• Automate manual and decentralized laboratory information management.
• Enable optimal utilization of resources and improve laboratory efficiencies.
• Enhance their data integrity and compliance with global standards.

Project Scope

• Master data synchronization with GSM application and Lab-wise sample distribution
• Sample type-wise responsibility distribution
• Machine-wise analyst qualification, sample management, sample analysis and approval
• Out of Specification (OOS) Investigation and Out of Trend (OOT) Analysis
• Email notification for desired activities with electronic signature and audit trail

Solution Approach

• End-to-end responsibility of the implementation from User Requirement Specification (URS) Compliance, FDS, Installation Qualification (IQ), Operational Qualification (OQ) and assistance in Performance Qualification (PQ), Requirement Traceability Matrix (RTM), and VSR.
• The customer’s R&D team initially created the Master data in GSM system. This avoided recreation of master data in LIMS, thereby increasing resource utilization and process efficiency

Systems & Tools

• SAP MII (Manufacturing Integration and Intelligence)
• SAP QM
• S-LIMS