CanadaBuys #25-58304

NRC Solicits Electronic Quality Management System (eQMS) for Clinical Trial Facility

The National Research Council Canada (NRC) is seeking proposals for a secure, compliant Electronic Quality Management System (eQMS) to support its Clinical Trial Material Facility (CTMF) in Montreal. - Government Buyer: - National Research Council Canada (NRC), Human Health Therapeutics/Clinical Trial Material Facility (HHT/CTMF) - Contracting office at 1200 Montreal Rd, Ottawa, ON - Products/Services Requested: - Electronic Quality Management System (eQMS) solution, deployable on-premises or in a Protected B cloud - Implementation, configuration, migration, validation, and training services - Software licenses for initial 3 years, with two optional 3-year extensions - Backup solution licenses for data integrity and restoration - Software upgrades (including major upgrade in year 4) - Exit management services for data export and portability - Hypercare support during implementation - Optional additional administrator and full user licenses - Key Requirements: - Must support modules for deviations, CAPA, change control, audit management, document and training management - Initial capacity for 40 users and 10,000 documents, scalable to 80 users and 50,000 documents - Bilingual support (English and French) - Compliance with Health Canada, FDA, EMA, GMP, and Canadian government security standards (ISO 27001, 27017, 27018, SOC 2 Type II) - Must meet Government of Canada Protected B security requirements - OEMs and Vendors: - No specific OEMs or vendors are named; opportunity is open to all qualified providers - Notable Details: - Both on-premises and cloud-based solutions are eligible - Deliverables must be received by the specified deadline, with ongoing support and upgrades in option years

Description

The National Research Council of Canada (NRC) is seeking to acquire and implement a secure, efficient, and compliant Electronic Quality Management System (eQMS) to support its quality and compliance processes. The eQMS must provide comprehensive functionality including non-conformance, document control, change management, audit management, training, and corrective and preventive action (CAPA) tracking. The solution must comply with NRC's Protected B security requirements, Government of Canada policies, and international standards such as Health Canada, FDA, EMA, ISO 27001, ISO 27017, ISO 27018, and SOC 2 Type II. The contract duration is 115 months, and the procurement method is competitive open bidding with selection based on the highest combined rating of technical merit and price.

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