Warning letters and citations from the US FDA on the rise in the pharmaceutical industry. With approximately one in five warning letters in 2018 and 2019 mentioning 21 CFR Part 211 section 166 (Stability Testing) this part of the regulations also appears to be on the rise.
Stability testing has a key role in managing drug safety and efficacy. Learn how to create a defensible framework for stability testing in this article.
Integrated or standalone, Sunquest solutions extend throughout the laboratory, augmenting integration between or across systems and expanding your abilities with added connectivity, precision medicine, or laboratory and pathology depth. In a series of videos, let’s follow patient Bob through his care journey, and learn why Sunquest is the One delivering Labs to new heights – driving better patient outcomes and return on investment. [SEE BOB’S JOURNEY]
November 17, 2020 - Setting Up and Managing COVID and Other Public Health Risk Testing in the Workplace
There is nothing people want more right now than a return to normal. By this time most of us have had enough of this surreal “new normal” where masked people tread carefully amongst each other, avoiding nearness, spraying down surfaces, using hand sanitizer, avoiding theaters, indoor restaurants, bars, and concerts, working from home and becoming far more familiar with Zoom than they ever…
November 17, 2020 - Lab Informatics Case Study: Informatics Roadmap for a Global Biotechnology Company
A global biotechnology company focused on discovering and developing treatments for people living with rare metabolic diseases maintained R&D facilities around the world and had plans to develop manufacturing facilities in the near future. The organization engaged in collaborations with Universities and worked with clinical research organizations (CROs) in the testing and analysis of samples. The company had been managing its scientific data with an ELN and a variety of paper/Excel based processes and recognized the need for a long-term R&D Informatics Strategy and Roadmap aligned with the needs of their R&D activities. [Read More]
Advances in the digital transformation of scientific labs are occurring so fast that it’s hard to keep up—as if COVID-19 hasn’t given labs enough to keep up with already. But when you consider how much these advances help researchers improve efficiencies, tap into higher-quality data and, ultimately, accelerate the launch of game-changing developments, it becomes clear that laboratories can’t afford to fall behind. [Read More]
Congrats on implementing STARLIMS for your laboratory! This may come as a shock, but you probably aren’t using some of the great features of the LIMS, right out of the box. Like most laboratories, just getting an informatics system in place can be a tough process, forcing a lab to focus on critical items first, like sample reception, testing, and approvals. This means that other enhancements, modules, and features can be placed on the backburner or even forgotten. [Read More]
In today’s anatomic pathology (AP) lab, molecular testing plays an increasingly important role in informing treatment decisions. With Sunquest’s integrated reporting capabilities for AP and molecular testing, review combined results in one actionable report for more coordinated, efficient care. [READ MORE]
On April 20th, 2010, a massive explosion on BP’s Macondo well in the Gulf of Mexico killed 11 people and began the largest marine oil spill in history. Before the spill was over, 206 million gallons of oil were released into the Gulf of Mexico, ultimately affecting wildlife and water-quality along hundreds of miles of Gulf coastline. According to BP’s Deepwater Horizon Accident Investigation Report, reasons leading to the accident were lack of good technical documentation and non-adherence to the documents that did exist. [Read More]
See how Baylor College of Medicine’s Human Genome Sequencing Center uses Exemplar NGS LIMS from Sapio Sciences
The BCM-HGSC is a world leader in genomics and one of the most technologically advanced laboratories processing a high volume and wide variety of samples and protocols. They have experienced dramatic growth in both the volume and complexity of the DNA sequencing including for COVID-19 testing. Click here to see how Baylor uses Exemplar’s NGS LIMS to meet their demand and how Exemplar has become an essential part of their future
November 5, 2020 - Sample Tracking is Essential for Organizations that Outsource Laboratory Testing Activities
Determining the pros and cons of operating an in-house laboratory or sending samples out to an external laboratory to be tested is increasingly topical. Whether your products are toys or fish pies, cars or shoes, blood products or water, nearly all testing can be performed by a contract laboratory.
But It is a mistake to think that outsourcing your laboratory means you do not need a system for tracking samples and the resulting data.
ABOUT THIS WEBINAR: Are you interested in learning the secrets of LIMS configuration to allow easier modifications, extensions and upgrades? How can you ensure your implementation is successful? Learn what drives successful LIMS projects, unwrap the secrets of configuration, and discover the pitfalls to avoid.
Benchling is a next-gen laboratory informatics platform that is helping life science companies manage increasingly complex data workflows. GEN Edge talks to CEO/co-founder Saji Wickramasekara and Michael Schwartz, Head of Product Marketing.
Sunquest Mitogen LIMS is a comprehensive and flexible molecular and genetic laboratory information management system. As COVID-19 continues to spread throughout the world, Sunquest Mitogen LIMS for COVID-19 is available to labs looking to quickly stand up testing in response to the pandemic.
During this pandemic, around half of labs worldwide are shut down and only 14% of labs are fully functional at a time when 100% of labs need to be thriving. Support for labs impacted by the restrictions imposed by the crisis is critical. Tools such as laboratory information management systems (LIMS) and electronic laboratory notebooks (ELNs), among other solutions, can help mitigate the impact on life in the lab.
LIMS implementations are often under discussion and get deemed as long term expensive projects with high costs.
But why are these implementations so expensive? Do they really have to take many months or years of time? Can we still call it a product if it needs so many additional services?
We’ll explain why they don’t need to be so.
The process of software validation ensures that the system fits its intended use and functions as it should. Computer system validation (CSV) for laboratory informatics is essential because regulated businesses must ensure the safety of their products for consumers, and their laboratory informatics systems (LIMS, ELN, CDS) are an integral part of that. Given its… Read More
The following blog will detail SampleManager LIMS Instrument integration best practices and procedures to ensure success.
Technological advances in laboratory instrumentation, along with higher throughput processes, have led to massive increases in the volume of analytical data. One of the main challenges faced by organizations today is turning this vast amount of data into useful information that fuels innovation and enables timely and effective business decisions.
With the end of summer came the return of fall favorites – turning leaves, cooler weather, pumpkin spice, and much more – but also with the fall came flu season, which is particularly worrisome as we battle the COVID-19 pandemic. In Sunquest’s latest blog post, learn how labs can quickly put pooled testing in place to help manage through a fall or winter surge of COVID-19.
Nearly 70 million strong, Millennials are now the largest generation in the American workforce. This generation is tech savvy and, having grown up with 24/7 internet access, sees the world as being connected through technology. Millennials often prefer to interact with others via e-mails and text messaging as opposed to face-to-face communication. As such, corporate training for the Millennial generation may best be accomplished through internet-based delivery systems.
The digital revolution is fueling a rapid increase in both data volume and complexity that is fundamentally changing how people work, think and address challenges. Industry leading organizations looking to capitalize on this paradigm shift are reinventing business models and processes using novel data sources and technology (cloud, mobile, data analytics, machine learning, AI and more) in a process known as digital transformation.