A recent United States Pharmacopoeia (USP) stimulus to the revision process paper1 has taken a life cycle approach to the development, validation and use of analytical procedures. Do chromatography data systems (CDS) have adequate functions to help analytical scientists meet these requirements when the pharmacopoeia is updated?
Sample Scheduler for OpenLAB CDS is designed to simplify sample management with laboratory...
DataApex has announced the release of a control driver for Symbiosis Technology Components...
The Clarity MS Extension control driver for Advion’s expression compact mass spectrometers (CMS) includes both digital control of the detector and digital data acquisition of the detector signal. It also allows performance of all service operations necessary for the detector from the Device Monitor software window.
Tens of thousands of pot smokers wheezed a sigh of relief when recreational marijuana use was made legal January 1, 2014. Gone is the cottage industry of gray-area physicians rubber-stamping medical prescriptions for a well-informed gaggle of would-be stoners who memorized popular conditions sure to garner approval.
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 release data and supportive testing at face value. Even worse, this effort is justified: they have cited a number of firms for violations of data integrity, a most fundamental bond of trust between manufacturers and the regulators that inspect them. Industry must take bold steps to assure the data used for drug quality decisions is trustworthy...
Data integrity is a current hot topic with regulatory agencies, as seen with recent publications in this magazine, and audit trails are an important aspect of ensuring this in computerized systems. The purpose of this article is to compare and contrast the EU and FDA GMP regulatory requirements for computerized system audit trails.
One of the challenges in laboratory data management is the handling and exchange of experiment data. Many vendors provide excellent instruments, but most produce data in their own proprietary formats. This leads to major difficulties for data processing, collaboration, instrument integration and archiving. The ASTM AnIML standardization effort addresses these problems by providing a neutral XML-based format for exchanging scientific data.
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
NuGenesis 8 featuring LE (Laboratory Execution) Technologies is a comprehensive data management and workflow solution designed to more effectively connect organizations' analytical laboratory data systems to their business information technology systems
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)
The technical library of liquid chromatography-mass spectrometry (LC-MS) solutions for endocrine drug analysis in clinical research includes methods showcasing the ability of automated sample preparation and multiplexing to reduce sample preparation time and maximize mass spectrometer throughput.
A team of scientists has used the NASA/ESA Hubble Space Telescope to observe a quasar accretion disc -- a brightly glowing disc of matter that is slowly being sucked into its galaxy’s central black hole. Their study makes use of a novel technique that uses gravitational lensing to give an immense boost to the power of the telescope. The incredible precision of the method has allowed astronomers to directly measure the disc’s size and plot the temperature across different parts of the disc.
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.
Behemoth sunspot 1302 unleashed another strong flare -- an X1.9-category blast. NASA's Solar Dynamics Observatory (SDO) recorded the extreme ultraviolet flash.
Astronomers have discovered the darkest known exoplanet -- a distant, Jupiter-sized gas giant known as TrES-2b. Their measurements show that TrES-2b reflects less than one percent of the sunlight falling on it, making it blacker than coal or any planet or moon in our solar system. The new work appears in a paper in the journal Monthly Notices of the Royal Astronomical Society.
- Page 1