Organization/Business Function Background
The Analytical Development (AD) and Quality Control (QC) laboratories play a critical role in ensuring the integrity and quality of products within our organization. To enhance our chromatography systems, we are implementing Empower software for comprehensive data acquisition, processing, and reporting. Empower simplifies the management of chromatography test results, facilitating accurate and efficient analysis.
Caducee serves as the operating system that integrates Empower, providing a robust platform for laboratory data management. As part of our ongoing efforts to establish a state-of-the-art laboratory at our Waltham facility, we are building infrastructure that connects lab computers to Empower via lace boxes interfacing with Caducee.
Scope Description
This Scope of Work outlines the responsibilities and deliverables for hands-on and administrative support related to the implementation and management of chromatography systems in the Analytical Development (AD) and Quality Control (QC) laboratories.
Management of LAC/e Boxes
- Install necessary drivers for LAC/e Local Access and Control (LAC) and e-boxes
- Connect LAC/e boxes with lab instruments to ensure data flow and system integration
Reporting Methods Development
- Collaborate with the digital team to develop, create, and maintain reporting methods
Custom Field Updates
- Coordinate with the digital team to update custom fields in Empower
Instrument Nodes and Systems Management
- Set up and manage instrument nodes and systems for both AD and QC laboratories
Empower Training
- Provide basic on-site training for local staff
Audit Trail Checks
- Conduct periodic checks of Empower audit trails
Administrative Support
- Digital Functions for QC Lab Operations
- User Account Management
- System Backup Support
- SOP Development
- User Access Forms Maintenance
- GMP Documentation Maintenance
- Application Troubleshooting
Digital Functions for Lab Instruments and Operation
- Lab Computer Management
- User Account Setup
- Daily On-Site Support
Software Licensing
- License Management
- Collaboration with Global Teams
- Digital Inventory Management
- Data Archival Solutions
Expected Benefit
Successful implementation will enable the QC and AD team to support on-time release, stability, and characterization testing.
Successful vendors will have demonstrated success in:
- Proven track record of supporting Caducee/Empower
- Managing systems administration
- Supporting Senior level experience in Lab Systems Administration/Support
- Overseeing resources within a GMP environment
- Caducee (UPMTC, DS, SPT, deployment in Production environment, etc.)
