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...
Welcome to Informatics Snapshot — a feature that highlights the standout properties of the...
The Pittcon Organizing Committee has announced that Innovative Publishing, producer of Food Labs...
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.
The Tobacco Testing Module, an add-on to the BlazeLIMS Enterprise product, features a comprehensive testing request submission form that embodies FTC, ISO, MASS, Sidestream and other testing regimes in a configurable and easy-to-use form, allowing for the entry of complex sets of brands and testing requirements.
JCL Bioassay Uses Thermo Scientific Watson LIMS to Optimize Communication, Data Management and Quality ControlJune 26, 2013 9:28 am | News | Comments
Thermo Fisher Scientific announced that JCL Bioassay USA, Inc. has implemented Thermo Scientific Watson LIMS bioanalytical laboratory information management system. JCL, one of the largest contract research organizations (CRO) in Japan specializing in preclinical and clinical bioanalysis, recently expanded its small and large molecule bioanalytical services to the U.S. and standardized on Watson LIMS across its laboratories
Version 5.5 of the BlazeLIMS Enterprise and Small Enterprise products is designed to provide powerful human interface (HI) features for enhanced usability, including panels for navigation, hierarchical folders of objects (samples by state, etcetera), and an object browser, all configurable to best meet user needs.
Exemplar LIMS has been selected as the lab management solution for the Genomics Core Facility at The Mount Sinai Medical Center in New York. Sapio's LIMS system will track multiple next-generation sequencing (NGS) platform workflows from request through secondary analysis.
What if ISO 17025 wasn’t a standard, but instead was a technology that automated laboratory best practices? What if following the regulations to the letter — often without even thinking about it — actually led to better overall business performance? In that case, it’s likely every business would aggressively deploy that technology.
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