Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 4: System Design, Definitions and Overall AssessmentMay 29, 2015 1:56 pm | by R.D. McDowall, Ph.D. | Articles | Comments
This is the final part of a series reviewing and critiquing recent MHRA guidance for industry on data integrity. The first part of the series provided a background to the guidance document and discussed the introduction. The second part reviewed the data governance system, and the third part discussed data criticality and lifecycle. This part reviews the system design, some of the definitions, and finishes with an overall assessment.
Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 3: Data Criticality and Data Life CycleMay 29, 2015 12:21 pm | by R.D. McDowall, Ph.D. | Articles | Comments
This is the third of a four-part series reviewing and critiquing the recent Medicines and...
Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 2: Data Governance SystemMay 29, 2015 11:27 am | by R.D. McDowall, Ph.D. | Articles | Comments
This is the second of a four-part series reviewing and critiquing the recent Medicines and...
This new series of four articles takes a look at the new UK’s Medicines and Heathcare products...
Researchers are always searching for improved technologies, but the most efficient computer possible already exists. It can learn and adapt without needing to be programmed or updated. It has nearly limitless memory, is difficult to crash, and works at extremely fast speeds. It’s not a Mac or a PC; it’s the human brain. And scientists around the world want to mimic its abilities.
Seahorse Scientific Workbench is a vendor-neutral software suite for capturing, analyzing and sharing analytical data. It consolidates raw and result data from multiple experimental techniques in a single tool, based on the emerging ASTM AnIML Data Standard. Seahorse Mobile delivers scientific data to mobile devices and supports chromatography (HPLC, GC), mass spectrometry, NMR, optical spectroscopy, microplate reader, bioreactor and fermenter, medical imaging and process chromatography data types.
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.
Agilent and Shimadzu Enable Control of Each Other’s GC Instruments in Respective Chromatographic Data SystemsAugust 26, 2014 3:32 pm | by Agilent | News | Comments
Agilent Technologies and Shimadzu announced the release of each other’s GC instrument control for their respective chromatography data systems. The move provides customers in analytical laboratories with more freedom of choice when selecting a chromatography data system.
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 information management systems (LIMS). The EZChrom Edition effectively provides master sequence control by integrating all laboratory chromatography systems into a single user interface.
DataApex has announced the release of a control driver for Symbiosis Technology Components manufactured by Spark Holland BV. The Symbiosis is SPARK's unique solution for fast integrated online SPE‐LC‐MS automation (XLC‐MS). Clarity can now control more than 470 instruments in total.
OpenLAB CDS A.02.01 chromatography data system (CDS) software features exclusive benefits for chemical, petrochemical, high-throughput and regulated laboratories. It provides data acquisition, data analysis, reporting, secure storage and e-Familiarization capabilities that are designed to increase laboratory productivity and lower costs in all chromatography laboratories.
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 —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...
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
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