Nature of Logilab SDMS and its applicability for 21 CFR Part 11
Logilab SDMS is a closed system. Closed system means an environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system.
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You found your ideal candidate. Their resume and qualifications are what you are looking for, and they impressed you and your hiring managers during the initial or follow-up interviews. They seemed equally enthused about the opportunity, and you follow up with them for the next steps and wait for their response. Days go by, no email responses, and they are not answering your calls. What happened?
You have been ghosted. [Read More]
As if the looming need to feed the world’s growing population were not enough, farmers are dealing with many other challenges in sustaining their business. Farm automation can help the agriculture industry meet the needed increase in production, while at the same time solving labor shortage problems and allowing for increased care of the environment. Farm-focused agriculture labs can assist with soil and seed analysis, among other things, and utilize the data captured by drones and crop sensors to provide recommendations for crop rotation, fertilizer adjustments, or new pesticide treatments.
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Agaram Technologies’ Logilab SDMS is a generic software application designed to handle scientific instrument data from any analytical instrument and can facilitate data management with access control. Logilab SDMS will perform scheduled data capture, cataloguing, archival and facilitate restoring data and has capabilities to extract data of interest from instrument output to be pushed to external systems like Electronic Note Book (ELN), Laboratory Information Management System (LIMS) and Enterprise Resources Planning (ERP).
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Composable Architecture shifts the focus from
monolithic application suites and hosting to use of best of breed solutions as part of a unified platform-ecosystem. By leveraging business architecture, technologies, and agile thinking, organizations can speed discovery, gain greater agility, and enable flexibility to handle future changes. Many organizations find that the fundamental components to enable Composable Architecture are already in place.
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Pooling samples and testing the resulting single sample can help laboratories improve productivity, reduce reagent use, and cut costs. Pool-testing can be used to increase throughput if testing resources are limited or during times of increased demand.
Sample pooling is used in many industries.
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As automation continues to work its way into agriculture, large farms are using robotic farm equipment for much of the work that had been done by people. Computing and information technology have a significant role to play from guiding tractors around fields, advising farmers on what crops to plant given forecasted weather conditions and consumer demand, managing communications, and maintaining records and data. Our interests in this article are going to focus on computing and information technology in the realm of
agriculture research and laboratory testing.
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When technology changes, you must change with it. If not, your business could fall behind. Organizations can be easily swayed by new technology buzzwords such as digital transformation and AI/ML for the laboratory, without really understanding what will be required to enact that technology. As a consultancy to a wide range of companies, it is our business to stay at the forefront of laboratory innovation, learn all that we can about what the future may be, and share those learnings with our audience.
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Astrix participated as the Networking Reception Sponsor at the Pistoia Annual Conference in Boston, MA on Nov 1-2, 2022. This event had over 225 life sciences R&D representatives from many of the largest Pharma companies. Participants from Astrix included individuals from our Lab Information Systems group, Strategic Consulting Services group, and Marketing.
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Title 21 CFR Part 11 is the part of Title 21 of the Code of Federal Regulations that establishes the United States Food & Drug Administration (FDA) regulations on electronic records & electronic signatures (ERES). Part 11 sets out how a company operating in the US can use electronic quality records & digital signatures in place of paper-based documentation & ‘wet signatures’ in such a way that complies with FDA regulations.
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When writing job descriptions, there are seemingly little-known techniques that can turn your job postings into irresistible magnets for the right candidates. If you’re seeking quality over quantity and prefer to hire for longevity, then these four insider tips can shorten the interval between getting the attention of – and obtaining —the talent who’ll happily choose your organization.
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In an earlier
article1, we looked at the role
laboratory information management systems (LIMS) played in manufacturing/production operations, as well as their relationship to other control/database systems. This article is going to shift the focus to the source of those manufactured/production operations: research and development.
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One of the many benefits of a Laboratory Information Management System (LIMS) is that all laboratory data is captured in one place. This allows laboratories to easily extract Key Performance Indicators (KPIs) and detailed management statistics from the data, providing a rich source of information to optimize operations and eliminate wastage. Yet few laboratories take maximum advantage of this capability.
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GLP lays down a very important principle that the data captured or entered in the system must be accurate. In order to ensure accuracy, GLP necessitates computerized system must have the capability to validate, verify and filter the data for accuracy. Logilab SDMS ensures that users can verify the data that is captured from the instruments can go through a workflow process.
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No organization, no matter how large or small, is safe from missteps in their efforts to progress and evolve. Mergers and acquisitions are the largest and loftiest of all change efforts a company can set out to achieve, with roughly 70 to 90 percent of them failing abysmally according to the Harvard Business Review. Failure isn’t limited to large-scale change pursuits, though. HBR cites studies that indicate a staggering 60-70 percent rate of failure for all organizational change projects
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With all that’s going on in the world and its economies today, there’s no better time for manufacturers to turn to robotics solutions. From labor shortages and inflated material costs to supply chain backups and a potential recession, manufacturers are faced with many challenges. Those manufacturers who must design, produce, and test their products in controlled laboratory environments are no exception.
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In recent years, there has been an increased focus on
environmental, social, and governance (ESG) issues in the business world. From large corporations to small businesses, more and more organizations are looking for ways to incorporate ESG Initiatives principles into their operations. But what does this shift mean for the workforce? How are employees responding to these changes – and what does it mean for your business?
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Whether you’re choosing your first LIMS or thinking of upgrading to a different platform, it’s tempting to focus solely on product features and capabilities. But that’s only looking at part of the equation. It’s equally important to consider the services available for the product through the vendor and/or third parties.
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Logilab SDMS has been designed and demonstrated to be fit for purpose in a GLP environment and introduced in a pre-planned manner. The system’s operational validation process during its original product development as well as any project implementation stage includes requirement specification, design documentation, industry coding standards, unit and system testing processes with test documents and reports.
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Since
Pharmacovigilance programs are designed to manage—if not prevent—surprises, preparedness is a focus of enabling vigilance. To support executives tasked with managing their company’s PV and Safety risk, Astrix has developed the first-of-its-kind Program Preparedness Self-Assessment. Just as Open-Source software is code that is designed to be publicly accessible, the Astrix PV Preparedness Self-Assessment is being made freely available for use by the PV/Safety community.
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