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

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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.
Purpose

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
Project scope

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
Solution Approach

The Results

  • Enabled stringent and reliable processes
  • Imparted traceability across the value chain
  • Helped the plant to comply with regulatory requirements like 21 CFR Part 11
Results

Systems, Tools & Services Expertise

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

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