Most laboratories today now have some form of LIMS to help manage their workflow. There are many types of LIMS, ranging in complexity from spreadsheets to intelligent programs that manage nearly every lab function.
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Would a LIMS or SAP better meet the needs of your company? That is the eternal debate for organizations who are thinking about upgrading their laboratory tracking software to a professional management system - analogous to the Mac vs PC conundrum on an industrial scale.
ISO/IEC 17025:2017, general requirements for the competence of testing and calibration laboratories, is the international reference for laboratories carrying out calibration and testing activities around the world.
With international regulatory agencies calling for pharma companies to properly manage data integrity issues to ensure GMP compliance, Abbott Informatics demonstrates how their STARLIMS solutions can provide support for numerous systems.
Most organisations that are looking to implement a new LIMS or replace an aging one have a significant investment in a number of information systems.
FDA was perhaps understating a point when it said in its April 2016 Draft Guidance: Data Integrity and Compliance with cGMP that the increasing number of data integrity-related cGMP violations identified during its inspections was ‘troubling’...