Ah, 30,000 feet and some old Dire Straits on the headphones, and waiting for my warm Heineken. Perfect. Though I enjoy lambasting companies that get it wrong, I’m also quick to stomp my feet and clap my hands when companies get it right. And I’ll do that, I promise, but allow me my fun first.
Data Integrity in a Nutshell: Industry must take bold steps to assure the data used for drug quality decisions is trustworthyJanuary 7, 2014 12:31 pm | by Mark E. Newton | Articles | Comments
Regulatory inspectors have started digging much deeper into data, no longer accepting batch...
Data integrity is a current hot topic with regulatory agencies, as seen with recent publications...
A further look at this current emphasis and a few problems inspectors have identified. The integrity of data generated by a regulated laboratory can make or break a regulatory inspection or audit. If you think that the warning letter citations quoted in part 1 of this article were bad, give a thought for another company...
The integrity of data generated by a regulated laboratory can make or break a regulatory inspection or audit. This paper looks at what is required for data integrity from the basis of the GMP regulations. It presents examples of non-compliances found in warning letters and a regulatory action from the U.S. Food and Drug Administraqtion (FDA).
The paper versus paperless discussion is as old as the existence of commercial computers. In 1975, just after the introduction of the first personal computer Scelbi (SCientific, ELectronic and BIological), Business Week already predicted that computer records would soon completely replace paper. We all know that it took over 25 years before paperless operations were accepted and successfully adopted in our daily work.
The Clarity 5.0 chromatography data system is multilingual and is designed to provide a universal solution for any commercially available chromatograph. It includes a Mass Spactra (MS) data processing module that expands the capability of the software by providing interactive spectral analysis, peak purity analysis and compound identification based on a spectral library search.
The Conferee Networking committee is pleased to announce its annual Call for Topics for Conferee Networking sessions, which will take place during Pittcon 2014 at McCormick Place, Chicago, IL, March 2 to 6, 2014. These two-hour sessions provide a unique networking opportunity for attendees with similar interests to meet and resolve problems, discuss new techniques, or brainstorm new ideas in an informal setting.
Clarity2Go is an application for users of Clarity chromatography software that allows monitoring instrument status. It is for both Android and iPhone mobile phones and is compatible with Clarity version 4.0.4.
Chromeleon 7.2 chromatography data system (CDS) supports mass spectrometry along with mainstream front-end separation techniques in the same software package. It is designed to bridge the gap between gas, liquid or ion chromatography and mass spectrometry.
An area of accelerating market growth for electronic laboratory notebook (ELN) technology is in analytical sciences, particularly late state biopharmaceutical development and quality. The large number of ELN users in the un-regulated world of research has inspired organizations to gain similar improvements in efficiency downstream on the R&D continuum.
Asset Genius, an informatics-based business intelligence solution, is designed to enable laboratories to make effective decisions on how laboratory assets are deployed, utilized and managed throughout their lifecycle
Lessons learned from the 10th annual electronic laboratory notebook conference in Barcelona Michael H. Elliott The largest event examining the world of ELN is the annual IQPC ELNs and Advanced Laboratory Solutions conference held September 26-28 in Barcelona, Spain. This three-day event illustrated the evolution of the ELN market, as a majority of attendees have a system in production. This is a significant shift, considering that in 2002 conferees struggled to even define what an ELN should do; the talks were more about concepts than reality
LabSolutions DB offers LC/GC laboratories fast and secure management for their LC/GC data. The software integrates a data management function with LabSolutions LC/GC control and analysis software
Thermo Fisher Scientific has announced that its board of directors has approved the initiation of a quarterly cash dividend to its shareholders — the first in the company’s history
Thermo Fisher Scientific announced that Global Pharmaceutical Supply Group (GPSG Brazil), a unit of Janssen-Cilag, which is a pharmaceutical division of Johnson and Johnson, has implemented an integrated informatics solution consisting of a laboratory information management system (LIMS) and a chromatography data system (CDS)
Introduction to Bar Codes John R. Joyce, Ph.D. Web Exclusive Bar Codes, and to a lesser extent Radio Frequency Identification (RFID) Tags, are almost ubiquitous in the modern laboratory, and for good reason. They can serve many purposes, from simplifying sample identification to the communication of information between systems. However, if someone asked us to explain how a bar code worked, once we got past the superficial, most of us would be at a loss. Despite having greatly increased laboratory productivity and reduced the error rate in many laboratory functions, they are not a silver bullet for correcting sample identification and data transfer issues. To avoid shooting ourselves in our respective feet, or worse, it behooves us all to understand how bar codes work.
The world’s first three-dimensional plasmon rulers, capable of measuring nanometer-scale spatial changes in molecular systems, have been developed by researchers. These 3D plasmon rulers could provide scientists with unprecedented details on such critical dynamic events in biology as the interaction of DNA with enzymes, the folding of proteins and more
Laboratory informatics can take on many guises. John R. Joyce, Ph.D While most users may only be familiar with it in regards to laboratory information management systems (LIMS) or chromatography data systems (CDS), its reach is considerably broader than that. An example of this, which has the potential for directly improving a great many lives in the future, goes under the somewhat innocuous acronym of i2b2
10 essential chromatography data system compliance areas R.D. McDowall This article explores the steps necessary to ensure the integrity of data generated and maintained by chromatography data systems (CDS) in a regulated GXP environment. It has been driven partly by recent content of some U.S. Food and Drug Administration (FDA) warning letters and the publication of the new European Union (EU) GMP Annex 11 regulations
Atlas chromatography data system (CDS) instrument control software provides full control and chromatography data handling within Atlas for the Shimadzu Prominence XR HPLC, a network-ready HPLC
SampleManager 10.0 LIMS is a laboratory information management that provides access to data across the enterprise; delivers key business metrics to management; facilitates compliance with ISO, GLP and other regulatory requirements; and optimizes workflows and quality management
Chromeleon 7.1 is an enterprise-ready version of the Chromeleon 7 chromatography data system. It features support for Dionex ASE Accelerated Solvent Extractors, Fluorescence Detectors, and Summit HPLC Systems, as well as LC and GC instruments from Agilent, Waters and Shimadzu
Qualoupe LIMS is a full-featured laboratory information management system designed for all types of organizations, both large and small
Empower 3 is a compliant-ready chromatography data software (CDS) package for advanced data acquisition, management, processing, reporting and distribution
NuGenesis Scientific Data Management System 7.1 is structurally validated to support Waters Empower 3 Chromatography Data System (CDS) and Microsoft’s Windows 7
Knowledge Explorer 3.3 provides a platform where users can integrate experimental data, NLP results, public data sources and clinical information in order to accelerate discovery and improve health outcomes
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