Compliance with US FDA’s 21 CFR Part 11 Regulations is very critical for medical device and pharmaceutical companies. However, there are some grey areas that companies often face when they try to comply with 21 CFR Part 11. There is a common opinion or perception that we have seen where many companies think they are complying (often due to misunderstanding the requirements), but in reality, they are not.
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Modern laboratory informatics systems are essential to the efficient operations of both oil and gas production facilities and related research work. In research, ELNs can manage the progress of research projects with LIMS providing support for extensive routine testing programs. With a well-designed laboratory informatics architecture and attention paid to technology management and planning, a laboratory informatics system can support a petrochemical organization's research, production, regulatory, and customer support needs.
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Data migration has always been seen as a barrier to a laboratory information management system (LIMS). The process of transferring data from one system to another can be complex, challenging, and time-consuming. That is why organisations should carefully consider the data migration process when implementing a LIMS and ensure that all data is accurately transferred by an expert LIMS vendor.
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Selecting a Laboratory Information Management System (LIMS) for any lab is usually not a simple decision. There are different types of stakeholders i.e. users of the system, who expect LIMS to fulfill different requirements as each of them uses it for different purposes. Understanding and implementing the suggestions and requirements of all user groups provides increased value to a lab.
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As we start 2023, now is the perfect time to start thinking about your STEM career (Science, Technology, Engineering, and Mathematics) and which skills are most in demand.
According to the
Bureau of Labor Statistics (BLS), occupations in STEM fields are projected to grow by over 10% by 2031. This rapid growth means more opportunities than ever for aspiring professionals in the field.
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As a tight labor market makes it difficult to find staff, and tougher economic conditions start to bite, laboratory managers are being forced to think hard about driving efficiency. Using the power of computer-based laboratory informatics solutions provides an easy win, but many organizations are still not fully exploiting the benefits that solutions such as LIMS offer. Reducing the number of manual ‘touch points’ and interventions for samples and their data is key to driving up efficiency.
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Laboratory work depends upon highly skilled people and sophisticated equipment to produce knowledge, information, and data. The cost, value, and ROI for those products are affected by the methods used to record and manage them. Producing knowledge, information, and data is one key aspect of laboratory work. Keeping it useable, accessible, and searchable over the long term is key to maintaining its value and realizing the return on your investment in laboratory space, equipment, and personnel.
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This annex applies to all forms of computerised systems used as part of a GMP regulated activities. A computerised system is a set of software and hardware components which together fulfill certain functionalities. The application should be validated; IT infrastructure should be qualified. Where a computerised system replaces a manual operation, there should be no resultant decrease in product quality, process control or quality assurance. There should be no increase in the overall risk of the process.
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The Intake process and its corresponding tools have been a point of focus for companies updating their safety systems because the Case Intake (Initial Triage) Workflow phase can take up to 50% of the overall case processing time. While some companies are taking a “Big Bang” approach to evaluating (and replacing) safety systems, many look to maximize their investments by limiting their focus to improving or replacing their Intake tool.
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Modern-day laboratories are experiencing record volumes of samples to process and test. Labs need to process these samples effectively and efficiently, but how is performance easily measured? Key Performance Indicators (KPIs) measure laboratory performance and help paint a picture of what is truly happening in the lab. KPIs can also provide insight into continuous improvement opportunities to increase laboratory productivity.
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Laboratories in the mining and metals industries are under considerable pressure to turn out results as quickly as possible, and keep a close eye on costs. Laboratory informatics applications can provide a central repository for test results and make coordination of distributed research and production operations easier. Laboratory managers need to recognize the benefits of informatics early in the development of laboratory operations so they can benefit from them. A cloud-based LIMS can assist the implementation process by providing access to ready-to-run systems that do not require installation or IT support.
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Cell and gene therapy research is a rapidly growing field that holds great promise for treating a wide range of diseases and conditions. Laboratory informatics solutions, such as electronic lab notebooks (ELNs), laboratory information management systems (LIMS), and other digital tools, can play a crucial role in supporting this research by providing a secure and centralized platform for storing, executing, managing, and sharing experimental data and observations.
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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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When shopping for a laboratory information management system (LIMS), it’s best to remind yourself of the old idiom “you get what you pay for.” Deciding to add a LIMS to your laboratory is not a decision to take lightly, nor is choosing the best LIMS vendor to handle your project. Taking the time to make specific inquiries about your requirements, understand how the price is calculated, seek out references, and question things that seem too good to be true will save you the time and money of investing in LIMS software this year, and replacing it the next.
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Managing data is a crucial aspect of any laboratory of the modern age, regardless of its nature and type of activity. The Logilab Electronic Lab Notebook (ELN) is a key part of this data management process in a laboratory, particularly pertaining to controlled data capture. But how exactly does the software solution developed by Agaram Technologies achieve this functionality? And why is it important that laboratories should ensure controlled data capture in the first place?
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As pay transparency laws become increasingly common across the United States, employers must understand their obligations. These laws promote pay transparency, foster equity in salary practices, and reduce salary disparities between genders, races, and other categories. The range of regulations varies by state; this is part two of our two-series blog post. We cover the remaining states with statewide pay transparency laws, what those laws entail, who is affected, and what employers need to know.
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On the morning of December 26, 2019, LabLynx, Inc., a trusted laboratory information management system (LIMS) vendor in Smyrna, GA, received a peculiar email. Someone claiming to be Kris Kringle had visited LabLynx.com and filled out a form requesting to connect with a LabLynx team member and schedule a demo of the ELab LIMS software solution. The entire LabLynx office was abuzz.
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If you operate computer software, at some point you may need to consider some aspect of validation. As an end user of any software, you benefit from the
validation and testing that software underwent before it got to you. Validation of systems or instruments assures all parties that the object of the validation will function as intended. It is a valuable exercise for any organization, even those that aren’t in industries subject to government regulations around CSV. This blog looks at questions that many of the organizations we work with have around computer systems validation (CSV).
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Although it may seem counterintuitive, transplanting your lab’s data and workflows from your on-premises servers to a third-party’s cloud-based LIMS makes your lab more secure. Moving your lab’s operations into the cloud also splits responsibility for security between you and your cloud LIMS vendor. Security in the cloud is one factor laboratories must consider when adopting a LIMS. There are shared security responsibilities in a software-as-a-service (SaaS) business model and LabLynx’s cloud-based LIMS offers security advantages over an in-house application.
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Digital transformation is the bedrock of an overall positive scientific experience in the lab. For truly successful digital transformation, both the physical and data lab environments need to be carefully brought together. Lab information management systems, or LIMS, are an ideal solution, effortlessly integrating these two settings. This two-part blog series explores how to use LIMS to enhance the overall scientific experience: in this first blog, we focus on how flexible interaction with LIMS can improve the lab-centric environment.
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