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
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
Systems, Tools & Services Expertise
- SAP MII (Manufacturing Integration and Intelligence)
- SAP QM
- S-LIMS
our experience, your success
Image: Republica, pixabay.com (CC0 1.0)
