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Exploring data integrity guideline changes moving into 2020
European Pharmaceutical Review explores how a surge in the number of warning letters for data integrity failings have prompted regulators to publish new guidelines.
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Laboratory Information Management Systems (LIMS)
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Whitepapers/App Notes/Posters
Whitepaper: LIMS DIY: Is a Home-Grown or a Purchased LIMS Right For Your Laboratory?
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.
Whitepapers/App Notes/Posters
Whitepaper: The Gap Between LIMS Capabilities and QC Microbiology Needs
LIMS requires a high degree of customization to meet QC Microbiology requirements. This means LIMS implementations often lock users into a functionality set that can’t accommodate technology advancements and regulatory changes without considerable investments, time, effort and money.
Whitepapers/App Notes/Posters
Whitepaper: Choosing a LIMS or SAP for your laboratory
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.
Whitepapers/App Notes/Posters
Whitepaper: Digital transformation in QA/QC labs
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.
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Elemental impurities testing and specification limits – ICH Q3D
The introduction of ICH Q3D (Guideline for Elemental Impurities)1 was an additional safety-based guidance for toxic impurities that complemented the existing ICH Q3C(R5) (Impurities: Guideline for residual solvents)2 and ICH M7(R1) (Assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk);3 as well as the…
Whitepapers/App Notes/Posters
Application Note: Quality manufacturing solution – interfacing with third-party 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.
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Integrating data from QC and Production to enable fast, informed decisions
Managing the vast amounts of data involved in biopharmaceutical manufacturing and quality control workflows is often challenging due to the use of multiple stand-alone systems and devices that can act as information silos. However, with the need for tighter control of collected data, due to an increased regulatory focus, safeguarding…
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Eurofins: The largest scope of global services. The sharpest focus on data integrity.
Eurofins BioPharma Product Testing’s facilities deliver the world’s most comprehensive scope of harmonized GMP testing services and seamless regulatory acceptance.
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Driving real-time productivity insights with connected laboratory automation
Tecan is offering its customers unprecedented insight into how their Fluent® and Freedom EVO® liquid handing platforms are being used, thanks to its Introspect™ and Common Notification System (Tecan CNS™) software tools...
product
Product Hub: Sievers M9 Analyzers offer simultaneous TOC and conductivity compendia compliance testing
Sievers M9 Analyzers measure Total Organic Carbon (TOC) and Stage 1 conductivity simultaneously in association with Sievers Lean Lab solutions. They offer simultaneous TOC and conductivity compendia compliance testing for water quality assurance...
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AdvantaPure® completes full BPOG extractables testing of several silicone and TPE tubing products
Provides Drug Manufacturers with Extensive Test Results for Tubing Comparison...
webinar
ISO/IEC 17025:2017 – New definitions for specifications, decision rules & risk assessments for calibrations
30 April 2018 | By Vaisala
The 2017 revision to ISO/IEC 17025 includes better guidance on conformity and a new risk-based approach. In this webinar we discuss the revision in terms of temperature and humidity calibration in life science environments...
news
Siemens and Perceptive Engineering combining software solutions for the pharmaceutical industry
Siemens AG and Perceptive Engineering Ltd announce a partnership which offers Perceptive’s PharmaMV and Siemens Simatic Sipat software products closely integrated to provide a versatile solution for advanced control and optimisation applications in both continuous and batch pharmaceutical manufacturing...
news
Tecan to launch Fluent® Gx Automation Workstation for use in regulated laboratories
Tecan’s range of advanced liquid handling solutions will soon be enhanced with the introduction of the new Fluent® Gx Automation Workstation*, designed specifically to meet the stringent needs of clinical and regulated laboratories...