Laboratory Information Management Systems (LIMS)

1
Laboratory Information Management Systems (LIMS)

• Lindy A. Brigham
• Div of Plant Pathology and Microbiology
• Department of Plant Sciences
• PLS 595D Regulatory Issues in Laboratory
  Management
• February 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

4
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

5
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 customers 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 companys 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