Laboratory Information Management System

The vendor is required to provide to enhance regulatory compliance, streamline operations, and ensure data integrity, we are seeking a qualified vendor to provide and implement a laboratory information management system (LIMS).
• Deliver a secure LIMS solution that supports the complete lifecycle of radiopharmaceutical facility operations at UCSF, including:
o Document control, repository, and revision history
o Electronic batch records
o Integrated quality management system (QMS) workflows
o Barcode-enabled inventory tracking
o Compliance with current good manufacturing practice (CGMP) (21 cfr part 212) and food and drug administration (FDA) 21 cfr part 11
o Reporting functionality
o Capabilities for record editing by multiple users at the same time
o Role-based access control
• Provide dedicated implementation and training support.
• Complete successful implementation addressing issues that arise.
• Plan for high-quality post-implementation maintenance and product support.