SERVICE PROVIDER TO SUPPLY, CONFIGURE AND IMPLEMENT A LABORATORY INFOMRATION MANAGEMENT SYSTEM (LIMS), AND TO PROVIDE MA

RFQ/OBP437/2024/25

REQUIREMENT Onderstepoort Biological Products (OBP) requires the services of a supplier, with proven experience to supply, configure and implement a web-based Laboratory Information Management System (LIMS), user training, annual licenses, and provide maintenance and support for a period of three (3) years. The required solution is necessary for: · Sample management: Track samples from receipt to disposal · Test data: Manage test data and results · Workflow automation: Automate repetitive tasks · Instrument and application integration: Integrate instruments and systems · Data management: Centralize data and processes. Database integrated with other related databases including but not limited to ERP solution · Quality control: Ensure work meets regulatory requirements · Reporting: Generate test reports and real-time reporting · Data integrity: Enhance data integrity with audit logging and revision control · LIMS training for 22 end-users and for two (2) IT staff SOLUTION CAPABILITY The solution must comply with the following functionality: · Sample Management o Accessioning samples o Barcoding / QR Code o Clinical or phenotypic information o Sample location · Instrument and Application Integration o Importing and management of raw assay data result e.g. qPCP, deep sequencing, o Adaptability to different assay formats at data and import creation layers o BLOBs storage · Electronic Data Interchange o Management of input and out data o Remote collection sample data imported and exported o Mobility · Integration of the DBMS with other DBMS in on other major system including but not limited to ERP Additional Solution Functionality This includes but not limited to: · Audit management - Fully track and maintain an audit trail · Barcode / QR Code handling - Assign one or more data points to a barcode / QR code format; read and extract information from a barcode / QR code · Chain of custody - Assign roles and groups that dictate access to specific data records and who is managing them · Compliance - Follow regulatory standards that affect the laboratory · Customer Relationship Management - Handle the demographic information and communications for associated clients · Document Management - Process and convert data to certain formats; manage how documents are distributed and accessed · Instrument calibration and maintenance - Schedule important maintenance and calibration of lab instruments and keep detailed records of such activities · Inventory and equipment management – Measure and record inventories of vital supplies and laboratory equipment · Manual and electronic data entry - Provide fast and reliable interfaces for data to be entered by a human or electronic component · Method management - Provide one location for all laboratory process and procedure (P&P) and methodology to be housed and managed as well as connecting each sample handling step with current instructions for performing the operation · Personnel and workload management - Organize work schedules, workload assignments, employee demographic information, training, and financial information · Quality Assurance and Quality Control - Gauge and control sample quality, corrective and preventive action (CAPA), data entry standards, and workflow · Reports - Create and schedule reports in a specific format; schedule and distribute reports to designated parties · Templates – create templates for laboratory activities eg. Form templates · Time tracking - Calculate and maintain processing and handling times on chemical reactions, workflows, and more · Traceability - Show audit trail and/or chain of custody of a sample · Workflows - Track a sample, a batch of samples, or a "lot" of batches through its lifecycle DELIVERABLES • Submit solution presentation when responding to bid. • Project Management with Complete documentation of the solution (Test, sign-off and handover) • Solution design • Solution Configuration and deployment • End user and IT training • The service provider is required to deliver the following: · On premises Web-based LIMS solution specific to OBP processes o Good Manufacturing Practice (GMP) Compliant with GAMP5 requirements o Compliance with FDA’s 21 CFR Part II o ISO/IEC 17025 o ISO 20387 · Provide validation documents i.e. DQ/ IQ/OQ · Execute validation Protocols i.e. DQ/IQ/OQ · Provide maintenance and support (time and material) for the solution for a period of three (3) years including but not limited to: o Upgrades and patches in line with OBP change control procedures o Yearly license renewal for: § Solution; and § 24 end-user licences including Two (2) for internal IT. · Enter into a Service Level Agreement with OBP.

Request for Quote

2024/12/11 11:00:00

No

RFQ/OBP437/2024/25