LIMS, Laboratory Automation Software and Data Integrity

As regulatory requirements continue to evolve, and instrumentation becomes more sophisticated, laboratories find themselves managing increasing amounts of data, a comprehensive data management plan, including LIMS (Laboratory Information Management System) and automation are critical. Given the vast amounts of data and information that must be collected, managed and maintained, a LIMS is no longer a luxury but a necessity. Leveraging LIMS and automation, no only ensures valuable resource utilization, as knowledge workers should not be copying and pasting data or transcribing data from one system to another. Laboratory automation with the LIMS includes positive ID (barcoding), instrument integration, sensors, CDS (Chromatography Data Systems) and enterprise integration (SAP, CRMs, Statistical, validation, accounting and other software).  Laboratories must manage raw data as well as meta data, along with audit trails of all the data handling systems, LIMS, instrument data management systems, and chromatography data systems. As the final product of the laboratory is data, it is critical that the data be accurate and precise. We will discuss the meaning of data integrity and what constitutes good data, throughout the data life cycle along with understanding the ALCOA+ acronym.  Laboratories must be following electronic records, electronic signatures as well as 21 CFR Part 11, predicate rules, cGMP and GxP. Additional compliance requirements include technical and procedural controls, critical in Pharmaceutical and Medical Devices, along with Standard Operating Procedures, IQ (Installation Qualification), OQ (Operational Qualification) and PQ (Performance Qualification) as part of the Quality Management System. When there is a failure in the laboratories Quality Management System, which encompasses the elements that are defined above, an FDA enforcement action could result in the form of a warning letter, seizure, injunction or criminal prosecution. 

Learning Objectives:

1. Discuss Data Integrity. 

2. Explain the acronym ALCOA+ and the role that LIMS and laboratory automation play in facilitating the ALCOA+ principles. 

3. Discuss the important role that LIMS and Laboratory Automation software play in ensuring Data Integrity, via data import, tracking, audit trails, data management, automated instrument integration, automated reporting, importing sensor data from incubators, fridges and freezers, traceability and more.