Best Practices for a Data Migration Plan and Integration of a New Pharmacovigilance System

An effective data migration plan ensures your data is accurate and thorough during the critical transfer phase from the source platform to the destination platform. Once your team is assembled, it is crucial that they focus first on mapping, selecting, preparing, extracting, transforming, and transferring to the new system data that’s of the proper form and quality. [Read More]

Discover the Power of ApolloLIMS Backed by CliniSys Group

Earlier this year, ApolloLIMS and HORIZON Lab Systems were acquired by CliniSys Group to grow the organization’s community and public health diagnostics capability.  CliniSys is one of the largest providers of laboratory information systems (LIS), order entry and result consultation, and public health solutions in disease surveillance and outbreak management across the United Kingdom, Europe, and United States. [Read More]

Navigating LabWare’s Message Engine Template

Example 1 LabWare Message Engine WorkflowDoes your LabWare implementation connect to external applications, such as SAP, another LIMS solution, or an external database? Are there multiple interfaces between LabWare and those external applications? If so, your LabWare implementation will greatly benefit from the Message Engine Template, as it is LabWare’s standardized and validated way to connect with external systems. In this post, we’ll learn about how LabWare’s Message Engine works... [Read More]

Laboratory Informatics Weekly Update – Volume 20, Issue 33

August 17, 2022 Laboratory Informatics Weekly Update Volume 20, Issue 33   In This Issue  Featured Books Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States  Featured Content 08/17/2022 - Iterating a Validated Assay? You Need Effective Change ManagementDay-to-day lab operations rely on workflows to manage people, tasks, and systems so that work follows a consistent process every time. Defined workflows help ensure that all the steps are done in the correct order, are free from errors, and meet regulatory requirements. But, representing lab workflows can be difficult. [Read More] 08/17/2022 - Reducing Human Error…

An assessment of solvent residue contaminants related to cannabis-based products in the South African market

Following up on 2021 research on heavy metal contaminants in the South African cannabis market, Vivierset al. similarly describe solvent residue contaminant found in the same market in this 2022 paper published in Journal of Cannabis Research. Noting a dearth of such research in the South African market, the authors acquired 279 samples and had them analyzed in duplicate for a specific set of Class 1–3 solvents. The authors turned to headspace gas chromatography–mass spectrometry (HS-GC-MS) analysis , the United States Pharmacopeia (USP) <467>, and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Q3C to guide their analyses. After a brief discussion of materials and methods, the authors present their results and conclusions. They found among its analyzed 279 samples, "a total of 111 samples had at least one solvent analyte that failed the USP and ICH specification limit (37% failure rate)," with the failure rate increasing 2% for summed solvent concentrations. They conclude that "when assessing solvent residues present in samples against a set of pharmacopeial safety limits, it is evident that a large fraction of cannabis-based products in South Africa exceeds these limits."

Improve Laboratory Accuracy and Reporting Quality with a LIMS

Errors may appear at any point in the laboratory workflow, from sample preparation and test setup to instrument calibration and report creation. Inaccuracies lengthen turnaround times, reduce efficiency, and potentially lead customers to poor decisions based on incorrect or missing data. Using a laboratory information management system (LIMS) to constrain sources of pre-analytical, analytical, and post-analytical errors offers benefits beyond just improving test accuracy.  [Read More]

The Elusive Promise of Managed Change

I love the work of change management because it is messy, unpredictable, and deeply personal. Humans, when taken individually, are complex and full of surprises. But aggregate the expected behavior of 10, 50, or even 10,000 humans and the possible outcomes are practically limitless. I have yet to experience a boring day on a change management project and I don’t expect to live through one any time soon. [Read More]

How Logilab ELN helps organizations to maintain ALCOA Data Integrity

Data integrity, an area of increasing priority in today’s laboratory world and “The focus area” when it comes to regulatory compliance such as 21 CFR Part 11 and Eudralex Annex 11.  Considering the number of warning letters from US FDA and other such regulatory bodies issued to pharmaceutical and medical devices manufacturers across the globe, Data integrity is the “Buzz word” in today’s audit. [Read More]

HR in the Digital World: The Future of Human Resources

Human resources have always been a critical function in any company. But with the digital age, the future or human resources is becoming an even more essential component of business success. To stay ahead of the curve, HR must undergo a digital transformation. This means deploying digital platforms for employee engagement, introducing personalized training and skilling programs, and using automation and analytics for insights and efficiency. [Read More]

Celebrating The Go-Live of the STARLIMS Quality Manufacturing (QM) Solution At Jiuzhou Pharma

The project went live successfully on June 15, with an implementation cycle of only 4 months. During the severe epidemic lockdown in China, the STARLIMS team collaborated closely with the customer, coordinating resources efficiently between different parties. Under the strict quality management and project management, the STARLIMS system has been successfully delivered on time to support the customer’s long-term development. [Read More]

Laboratory Informatics Weekly Update – Volume 20, Issue 32

August 10, 2022 Laboratory Informatics Weekly Update Volume 20, Issue 32   In This Issue  Featured Books Past, Present, and Future of Cannabis Laboratory Testing and Regulation in the United States  Featured Content 08/10/2022 - Improve Laboratory Accuracy and Reporting Quality with a LIMS Errors may appear at any point in the laboratory workflow, from sample preparation and test setup to instrument calibration and report creation. Inaccuracies lengthen turnaround times, reduce efficiency, and potentially lead customers to poor decisions based on incorrect or missing data. Using a laboratory information management system (LIMS) to constrain sources of pre-analytical, analytical, and post-analytical…

Electronic tools in clinical laboratory diagnostics: Key examples, limitations, and value in laboratory medicine

In this 2021 paper by Bohn et al., a review of the utility and limitations of clinical laboratory electronic tools is given, along with a use case of the Canadian Laboratory Initiative on Pediatric Reference Intervals (CALIPER) online database. After a brief introduction, the authors examine both tools that are useful to the medical provider and tools useful to the patient, as well as a few caveats on their use. They then discuss CALIPER, a tool " aimed to improve blood test result interpretation in children by establishing accurate and robust pediatric reference intervals for important biomarkers of health and disease." They discuss the system in the framework of how such clinical electronic systems can assist doctors and patients through the laboratory. They conclude that "clinical laboratories should be leading and actively engaged in electronic diagnostic tool innovations that improve laboratory data communication and reduce post-analytical errors in test result reporting and interpretation," while at the same time considering "[i]nherent biases to data-driven technologies."

ELN – An ideal replacement for Paper Notebooks

ELN is developed to replace paper notebooks so that scientists and researchers can record and search their records much more easily and archive their data onto another electronic device. An ELN allows lab professionals to access, share, and analyze data using a computerized system. ELN software is an advanced application that allows lab professionals to maintain critical experimental information in digital form, making it easily retrievable, more secured, and reusable for future experimental needs instead of adopting outdated and manual approaches. [Read More]

7 Steps to Finding Your Ideal Clinical Diagnostics LIMS

Managing your clinical diagnostic laboratory’s information has become as important as managing the laboratory itself. More data-intensive technologies, more comprehensive regulatory compliance, and other trends require an effective laboratory information management system (LIMS) to effectively manage all that data.  Turning to an effective vendor selection process is among the most important of those lessons. Naturally, we think LabLynx should top your list! But how do you truly know a vendor is a good match? These seven steps will help you find the right LIMS for your laboratory. [Read More]

How Your Lab Can Represent Workflows Effectively

Day-to-day lab operations rely on workflows to manage people, tasks, and systems so that work follows a consistent process every time. Defined workflows help ensure that all the steps are done in the correct order, are free from errors, and meet regulatory requirements. But, representing lab workflows can be difficult. [Read More]

COVID Infections Surge While Laboratory Testing Wanes

iStock-1310117462 COVID cases have re-surged this summer in many regions of the US. New omicron variants are largely the cause of new waves of infection, fueled by increased summer travel and relaxed mask requirements. “Customers are telling us they’ve been ramping back up since May 2022 to handle more COVID testing,” says Robert Benz, marketing manager for HORIZON, now also part of Clinisys. The CDC COVID data tracker shows a steady rise in reported cases starting in the middle of March 2022. [Read More]

Working with a LIMS Consultancy – The Help You Didn’t Know You Need

working with lims consultants Yes, shelling out money for a third-party consultancy may seem counterintuitive when you’re contemplating making a big investment in a laboratory informatics management system (LIMS). However, the value companies gain by working with a LIMS consultancy provides multiple dividends. As laboratory staff, you are the expert in your research field, and no one expects you to also understand the intricacies of deploying a LIMS; that’s why consultancies exist. LIMS implementations are our specialty and we’re here to help.  [Read More]

LIMS Add Competitive Advantage to CDMOS

Contract and development manufacturing organizations (CDMOs) are a major resource in pharmaceutical & biotech product development, not only for smaller companies lacking research and manufacturing facilities but also for large organizations needing specific expertise. Lab information management systems (LIMS) are a key element in successful CDMOs, helping them transition to Industry 4.0 during the research and development phase, with synergies that even ease the path to manufacturing. [Read More]

The Impact of Organizational Change Management in Selecting a Pharmacovigilance System

Selecting a new pharmacovigilance system is a big decision that the company will have to live with for many years into the future. At Astrix, we advise our clients and assist in leading the process of selecting a new system which also involves organizational change management. A critical aspect to any change like this is to ensure that there is a strong alignment with the leadership team and everyone involved in the selection process. That cohesion is imperative. [Read More]

EVENT RECAP 20/15 Visioneers Webinar – Event Recap

EVENT RECAP 20/15 Visioneers Webinar - Event RecapStrateos had the pleasure of participating with Evariste Technologies in a webinar hosted by 20/15 Visioneers, about cloud lab automation-as-a-service being leveraged to accelerate cycle times for faster drug discovery. 20/15 Visioneers is invested in R&D, IT and informatics solutions to improve efficiencies, collaboration and harmonization driven by FAIR data principles, in silico initiatives and automated cloud labs.  [Read More]
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