The PrecisionMDx (PMDx) System is designed for molecular laboratories. It supports molecular diagnostic requirements of entrepreneurial molecular test development companies and the institutional services of molecular pathology departments in community, private and academic medical centers.
SLAS is a global organization that provides forums for education and information exchange to...
Sample Scheduler for OpenLAB CDS is designed to simplify sample management with laboratory...
Matrix Gemini Laboratory Information Management System (LIMS) includes versatile one-time configuration tools that allow the system to be configured without the use of custom programming and provide an audit trail each time a display screen for the system is updated or modified.
Accelrys Capture is designed to allow scientists to work more intuitively, efficiently and productively with laboratory informatics software like Accelrys Electronic Lab Notebook (ELN). The application’s interface provides a straightforward and secure way for scientists to enter information, view procedures, capture data from laboratory instrumentation by using small mobile devices
Smartphones are an important part of our everyday life, a trend that holds true for laboratories as well. In countless industries, features and applications on mobile devices allow staff working outside of the lab to easily and more accurately capture new types of data from remote locations. But without proper technology, working remotely also poses unique challenges.
Welcome to Informatics Snapshot — a feature that highlights the standout properties of the current crop of laboratory informatics systems. While not intended to be a full formal review of the featured product or to indicate whether the product is considered “good” or “bad,” its purpose is to present some of the “diamonds and rust,” as the Joan Baez song goes. In this article, we’ll take a brief look at the LabX system
The Pittcon Organizing Committee has announced that Innovative Publishing, producer of Food Labs Conference and publisher of Food Safety Tech eJournal, has signed an agreement for the second year for the co-location of Food Labs Conference to be held in conjunction with Pittcon 2014.
Exemplar NGS LIMS provides pre-built, clinical standard workflows for next-gen sequencing platforms, and also contains built-in sample management, electronic lab notebook (ELN), scientific data management (SDMS) and project dashboards.
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.
An optional grading module for the Matrix Gemini Laboratory Information Management System (LIMS) allows multiple specifications to be set up for products manufactured in batches. It provides the functionality required to assign the tests and apply the limits needed to determine the grade of any manufactured batch.
The Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy announced the 2014 Technical Program that includes over 2,000 presentations offered in symposia, oral sessions, workshops, awards and posters. This year’s program covers a wide range of applications such as biotechnology, biomedical, drug discovery, environmental, food science, fuels/energy, lab management, nanotechnology, polymers/plastics and regulations.
Accelrys, Inc. today announced that it has acquired Ireland-based QUMAS, a leading global provider of Cloud-based and on-premises enterprise compliance software supporting regulatory and quality operations in life sciences and other highly regulated industries.
STARLIMS 11 laboratory information management system (LIMS) expands user functionality to include mobile device applications, advanced analytics and HTML5 compatibility, enabling users to access LIMS information anywhere on any screen.
The Pittcon Organizing Committee has recently announced the topics for Conferee Networking during Pittcon 2014, which will be in Chicago, Illinois, McCormick Place, March 2 to 6, 2014. Conferee Networking sessions are free to all registered attendees and provide an informal venue for a small group of participants to openly discuss topics of mutual interest or solve problems specific to certain instrumentation or procedures.
Core Informatics, a provider of data management solutions to clients engaged in scientific research, announced that it has hired IBM executive Josh Geballe to serve as Chief Executive Officer. Geballe joins Core after over a decade at IBM where he held international executive roles spanning general management, finance and strategy.
The Pittcon Organizing Committee has announces the course listing for the 2014 Short Course program which runs March 1 through March 6, 2014. Short Courses are taught by industry experts; range from half-day up to two-day classes; and include beginner, intermediate, and advanced level curricula.
Core LIMS, ELN, SDMS 4.2 is designed to further extend the configurability of the Core LIMS product and to enable users to respond more promptly to rapidly changing informatics needs. The software extends the ability to configure personalized applications to include dashboard displays with administrator-defined dynamic content
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).
Accelrys, a provider of scientific innovation lifecycle management software, announced that it has acquired ChemSW, an Environmental Health & Safety (EH&S) compliance solutions provider. This acquisition furthers Accelrys' scientific innovation lifecycle management strategy by providing solutions for managing and tracking the source, use and disposal of chemicals along the entire lab-to-plant value chain.
The rapid increase of investment in biotherapeutics is changing the profile of the biopharmaceutical industry and, along with it, data management in the laboratory. With attention on longer patent life, high barriers to generic equivalents and personalized medicine, an increasing portion of R&D spending is being allocated to large molecule therapies
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.
The Limfinity information management platform is designed to allow laboratories to leverage personnel mastery and understanding to achieve automation and compliance, as well as gain a centralized repository for user, system and instrument data.
LABVANTAGE Solutions, a provider of laboratory information solutions, has welcomed Peter Bailey as the new Chief Executive Officer. Having served at GE, GE Healthcare and McKinsey, Bailey brings a background in global business leadership, innovation, business building, and corporate strategy.
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