Basic LIMS Application Certification

Service Description

Module 1: LIMS Functionality and Technology • Module 1: Flow Chart-LIMS, URS, how to create LIMS Master Data –Analysis, Product, Sample plan & Item code Module 2: Defining Business Requirements For LIMS (User Requirements Specification) –Initiation phase Validation Life-Cycle Approach through GxP Computerized systems-Initiation phase Module 3: LIMS GXP Assessment, Validation plan-FRA, FCS, IQ, OQ and PQ, how to create LIMS Master Data –Inventory Module 4: Configuration testing in Dev.- environment, Functional Testing in Quality environment, UAT Testing in Prod-environment, Basic awareness of Crystal reports Module 5: How to prepare the LIMS Validation summary Report, Environmental monitoring Module Workflow. Module 6: LIMS Architecture, Creation of Master data inventory and Inventory management workflow Module 7: Lot Management Workflow, Laboratory workflow and Master data instrument creation and Instrument Management workflow Module 8: Stability Management-Introduction, Stability storage Location management and Stability management entire workflow Module 9: LIMS Administration activities: User Management, Data Migration, Object package creation, installation and scheduler management in LIMS ,Investigation Management-LIMS. System Overview Description with diagrams (a concise nontechnical description of the functionality and operation of the LIMS covering all interconnected systems), which for complex systems should be a separate document providing a description of the systems that may be used to describe the system to a regulator System Architecture with details of hardware with diagrams Data Architecture with details of the sources, uses, and ownership of each static data item System landscape showing the interactions of the various instances of the application Interfaces with diagrams (including networks, systems, and analytical equipment) List of software modules with details of versions, standard software products (e.g. spreadsheet packages), etc. Number of users, user hierarchy, and response time required from LIMS Software design documentation Server environmental conditions including power supplies Client PC user interface software configuration details and terminal emulation requirements Functional descriptions of LIMS operations Business Continuity (Contingency) Plans, maintenance, and operating procedures Application software and reports Security and access control methods

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