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Laboratory Information Management Systems (LIMS)
Lindy A. BrighamDiv of Plant Pathology and Microbiology
Department of Plant SciencesPLS 595D Regulatory Issues in
Laboratory ManagementFebruary 2, 2006
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LIMS
• Definition: – A method a laboratory uses to manage its
data and disperse the results to designated areas
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Information Technology
• Why?– Management of the Information Explosion– Quality Assurance
• GLP, GMP, EPA, etc.
– Reduction of data entry errors– Need for faster sample/results turnaround
time
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General Considerations
• Different labs have different requirements
• Procedures and outcomes differ
• But all can use the systems approach to identifying their needs and implementing solutions
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Types of Laboratories
• Research
• Analytical Services
• Manufacturing
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Research Lab
• Many non-routine tests
• Low sample volume
• Flexibility between data and analyses performed
• Specification checking (FDA reqs)
• Traceability (calibration, distribution, data)
• Change control procedures (documentation of changes eg SOPs, QA compliance)
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Testing Services Laboratory
• Tests performed at customer’s request
• High sample volume
• Routine tests
• Variable workload
• Prioritized samples
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Manufacturing Laboratory
• Perform testing for various materials including:– Final product testing – Stability testing– Work-in-progress testing – Environmental testing– Raw materials acceptance testing
• Many tests per sample• Dynamic environment
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LIMS Acquisition
• How do you determine what you need and how to get it?
• Systems Approach to defining needs and specifications for a LIMS
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Acquisition Decisions
• Buy or Build? All or Pieces?
• Options– Design and build system ‘from scratch’– Piece together existing and off the shelf
components– Buy whole system from vendor
• How do you decide?
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By doing an Analysis
• The build or buy or buy what decision is made based on an analysis of the needs and practices of the lab
• The analysis itself can be of benefit to any lab to:– Clarify existing practices– Help eliminate non-essential practices– Organize and streamline existing procedures
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Systems Analysis and Design• Project Definition
– What is to be achieved, by whom and why• Functional Requirements
– all user entry requirements and system output requirements described in detail
• Functional Design– detailed documentation to describe the system and detail how the
functional requirements are to be achieved – independent of hardware and software requirements
• Implementation Design– selection of hardware and software
• System Integration– Gather all required components, interface components, install software,
go live• System Evaluation
– Final phase– Project definition and functional requirements are revisited and
compared to the final installed system to determine how well the requirements were met
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Analysis of UA Research Lab
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Workflow Overview – Research
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Workflow Overview – Analytical
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Information Management System
• Consists of:– Computer(s)– People– Procedures/Processes
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LIMS Resources
• Stand alone software– All purpose
• Word Processing• Spreadsheets• Databases
– Inventory– Document Management (Wolk)– Statistical Packages
• Total systems– Lablynx http://www.lablynx.com/– Starlims http://www.starlims.com/
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Regulatory Requirements
• ISO 9000– Management must define, implement, communicate and
maintain quality objectives and assign personnel at all levels of the organization to be responsible for verifying the company’s quality system
– Primarily effect manufacturing laboratories
• ISO 25– Establishes labs technical competence
• GALP (Good Automated Laboratory Practices)– Union of federal regulations, policies, and guidance documents
establishing a uniform set of procedures to ensure the reliability and credibility of laboratory data (EPA)
• 21 CFR 11 (1997)– Electronic signatures, Electronic records