Despite the fact that industries won’t change working processes unless there is a mandatory need to do so, major milestones are expected in 2015 in the battle to adopt data and standardization in our scientific community. The need for deployment of these integration standards to enable efficient sharing of knowledge across our internal and external partners is re-enforced by regulatory bodies.
The NuGenesis Lab Management System is designed to offer a unique alternative to a traditional...
The Pittcon Organizing Committee has announced that Innovative Publishing, producer of Food Labs...
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.
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).
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.
An unprecedented trillion-particle simulation, which utilized more than 120,000 processors and generated approximately 350 terabytes of data, pushed the performace capability of the National Energy Research Scientific Computing Center’s (NERSC’s) Cray XE6 “Hopper” supercomputer to its limits.
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.
Core Informatics, a provider of data management solutions to the life sciences, molecular diagnostics and energy industries, and OpenEye Scientific Software, a developer of innovative molecular modeling and cheminformatics solutions for molecular discovery, have announced a new partnership and the integration of OpenEye cheminformatics software into Core Informatics’ web-based Core LIMS and Core ELN.
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.
IO Healthcare is an extension of the Sentient life sciences platform into precision medicine applications, including biomarker discovery, clinical trial optimization and decision support
Laboratories working in the pharmaceutical industry in the areas of R&D and quality control find themselves increasingly having to cope with conflicting demands — tougher regulatory requirements and harsher economic realities. In order to meet these demands, new ways of dealing with process, data and system management are necessary.
Bioanalytical laboratories play a crucial role in the development of pharmaceutical drug products. Labs in large biopharmaceutical companies typically partner with other internal groups, such as pre-clinical toxicology and clinical pharmacology, to support their analytical requirements.
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
Accelrys Enterprise Platform offers a scientifically aware, service-oriented architecture that enables the integration and deployment of broad scientific solutions spanning data management and informatics, enterprise lab management, modeling and simulation, and workflow automation
The Ensemble for Biology platform is an informatics suite of applications for creating a collaborative and integrated biology workflow, from research and development to quality assurance and control
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
IBM has announced that it is working with The Louvre Museum in Paris to preserve and protect its facilities and artwork, which inlcudes handling more than 65,000 repairs and maintenance visits per year
In today’s pharmaceutical climate, data is plentiful, which is both a challenge and — as long as it is properly managed — an opportunity. And that’s where a vast number of data management systems and their developers come into the picture
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