LaboratoryInformationManagementSystems(LIMS).pptVIP

2/2/06 Regulatory Issues in Laboratory Management - LIMS PLP595D - LIMS 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 LIMS Definition: A method a laboratory uses to manage its data and disperse the results to designated areas 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 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 Types of Laboratories Research Analytical Services Manufacturing 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) Testing Services Laboratory Tests performed at customer’s request High sample volume Routine tests Variable workload Prioritized samples 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 LIMS Acquisition How do you determine what you need and how to get it? Systems Approach to defining needs and specifications for a LIMS 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? 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 pr