It’s no secret that laboratory operations play a central, fundamental role in the success of any Pharma enterprise. Whether filling the R&D pipeline or seeing to day-in-day-out quality and compliance regimes, lab operations deliver particularly valuable intelligence that supports just about every aspect of drug manufacture. Decision makers up and down the operational chain of command rely heavily on robust, reliable, high quality data and operational managers are under extreme pressure to deliver it to key stakeholders across the organization.
One of the most important current industry discussions centers not just on lab data, but on the quality – or integrity – of that lab data. The new guidance in 2016 from the U.S. Food & Drug Administration (FDA), the European Medicines Agency (EMA) and the Pharmaceutical Inspection Co-operation Scheme (PIC/S) aims to establish an environment where Current Good Manufacturing Processes (CGMP) are adhered to globally, ensuring data integrity throughout the entire pharmaceutical development process – from testing, manufacturing, packaging, distributing and monitoring of medicines.
A good article written recently by Thermo Fisher’s Darren Barrington-Light, a seasoned product and marketing manager in the Informatics and Chromatography business, and published in BioPharma International, outlines just how important data integrity is and some common areas where data integrity can be challenged. Paying attention to a few key areas of the holistic pharmaceutical workflow will reveal where data issues can occur. Mr. Barrington-Light recommends, in “Harnessing Advances in Informatics to Ensure Data Integrity,” that labs will benefit from Integrated Informatics solutions, where an enterprise-level laboratory information management system (LIMS) is fully integrated with all laboratory software such as chromatography data systems (CDS), lab execution/procedural electronic lab notebooks (LES/ELN), scientific data management systems (SDMS), as well as all laboratory instrumentation and equipment. The goal of this type of Integrated Informatics solution is to ensure that all data is electronically captured, thus eliminating the need for paper-based systems and reducing the incidence of human error. In addition, when your laboratory data is captured and centralized in a LIMS, it is automatically archived and available for any future use, such as a regulatory audit or a batch or production recall. With an SDMS built on the LIMS platform, all original instrument data is available at any time in the future, which is an important part of maintaining data integrity over the long term. Finally, an enterprise-level LIMS, like Thermo Scientific SampleManager, enables your lab to improve efficiencies not only in the lab but throughout the organization by making data available across your enterprise, integrating with production, R&D, manufacturing, and quality control. With an Integrated Informatics solution standardized across multiple remote sites, data integrity is achieved across global organizations.
To help our pharmaceutical customers manage the most complex data management challenges, we’ve introduced the latest evolution of Thermo Scientific Integrated Informatics, the center of lab data acquisition, management and storage. Integrated Informatics represents an essential development in laboratory software designed to help lab managers and scientists move more efficiently through their workflow – from ‘sample to knowledge’ – delivering data integrity, compliance, productivity and enterprise-wide data sharing. The foundation of Thermo Scientific Integrated Informatics is the SampleManager platform – with comprehensive lab and data management functionality for LIMS, CDS, SDMS and procedural ELN/lab and method execution. If you want to keep up to date with SampleManager LIMS, check out the latest published document, Thermo Scientific SampleManager LIMS, a complete laboratory solution. With Integrated Informatics, lab managers can consolidate their lab software investments, saving time and money in software licenses, implementation costs and ongoing service contracts.
Our latest eBook, Integrated Informatics & Chromatography Solutions for the Pharma/Biopharma Industry, reveals how highly integrated lab information technologies from Thermo Fisher Scientific can help drive innovation and ensure that your laboratory data is generated, archived and delivered with compliance in mind. We’re here to help you unlock the value of your data so you can leverage it to optimize your lab’s workflow and contribute to the overall health of your business. For more information, case studies, videos and product specific information, please visit us at www.thermofisher.com/IntegratedInformatics.
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