Laboratory Information Management Systems (LIMS) are widely used in the laboratories of pharmaceuticals and related industries. LIMS is typically based on client server technology supported by a Relational Database Management System (RDBMS) as a storage repository. 

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LIMS is now a mature technology, and many packages are commercially available. Therefore, this chapter will concentrate on the selection, configuration, and implementation of a LIMS in a pharmaceutical manufacturing environment, rather than the development of in-house software for laboratory management.

 

In this Basic LIMS training course you will learn End User Task other than administrative work like Lot Management Workflow, Laboratory workflow and Master data instrument creation and Instrument Management workflow etc. 

 

For Administrative knowledge go with Administrative LIMS Course Click here

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The introduction of LIMS (Laboratory Information Management System) into the laboratory is encouraged by Quality Assurance (QA)/Quality Control (QC) laboratory managers. It provides an automated, efficient, and regulatory-compliant means of dealing with the electronic data produced in the laboratory. The implementation of LIMS should also reduce the possibility of errors due to problems introduced by personnel performing repetitive scheduled tasks. There have been increasing demands from the regulatory authorities for data integrity, data security, and validation of LIMS in line with the current regulations and guidelines, 1–4 with LIMS becoming a focus of interest for these pharmaceutical regulators.

In this training Course you will learn End to End LIMS system Implementation from requirement gathering, Validation approach, Validation Plan preparation, functional and design understanding including architecture design aspects, Test scripting and its execution and finally preparation of Validation Summary Report. 

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• Module 1: LIMS Functionality and Technology, 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

1. System Architecture with details of hardware with diagrams

2. Data Architecture with details of the sources, uses, and ownership of each static data item

3. System landscape showing the interactions of the various instances of the application

4. Interfaces with diagrams (including networks, systems, and analytical equipment)

5. List of software modules with details of versions, standard software products (e.g. spreadsheet packages), etc.

6. Number of users, user hierarchy, and response time required from LIMS

7. Software design documentation

8. Server environmental conditions including power supplies

9. Client PC user interface software configuration details and terminal emulation requirements

10. Functional descriptions of LIMS operations

11. Business Continuity (Contingency) Plans, maintenance, and operating procedures

12. Application software and reports

13. Security and access control methods