Verification of data integrity is a critical part of the FDA’s mission to ensure the safety, efficacy and quality of human and veterinary drugs, biological products, and medical devices. As such, the FDA’s expectation is that all data generated to support the quality of manufactured products is both reliable and accurate.
Compliance violations involving data integrity have led to numerous regulatory actions by the FDA in recent years, including warning letters, import alerts, and consent decrees. In 2018 alone, the FDA issued 54 warning letters that had references to data integrity and data management deficiencies in pharmaceutical companies, 10 of which were in the United States. An analysis of 2018 warning letters by FDAzilla found that 45% of GMP-related warning letters issued to pharmaceutical companies based in the United States included a data integrity deficiency.
Due to the 75 million strong Baby Boomer generation reaching retirement age, a wide range of industries in the United States are currently experiencing labor shortages. Combine this with the fact that, for a variety of reasons, many Baby Boomers are delaying their retirement and you have a recipe for significant generational diversity in the modern American workplace. It is not uncommon these days for a 20-year-old new hire to work with colleagues 50+ years their senior. Many companies are, in fact, now employing a workforce that spans four different generations.
Since its inception in 2002, the annual Bio-IT World Conference & Expo has become a premier event for showcasing the wide-array of IT and informatics applications and enabling technologies that drive biomedical research, drug discovery & development, and clinical and healthcare initiatives.
This blog post is part of an on-going series about the LIMS and ELN implementation journey, specifically the Do’s and Don’ts of the implementation planning phase. Today’s post discusses who should be on your project team from outside the lab. We’ll take a look at who should be on the team and some of the activities they should complete.
“Getting” a LIMS or ELN is a much more complicated and lengthy journey than many organizations expect. For many labs, just defining requirements and refining a vendor short list can be a months-long endeavor, but there is much farther to travel after selecting your preferred LIMS or ELN product. Many clients envision an efficient, automated lab that runs on a shiny new LIMS or ELN, but we often see expensive software systems fail to live up to these expectations. LIMS or ELN licenses alone can cost hundreds of thousands of dollars, and at that price, how could they not perform as promised?!
This blog post examines the LIMS and ELN Implementation Planning part of the journey and highlights some common problems to avoid as you traverse the road to your laboratory informatics destination.
PITTCON celebrated its 70th year this year making it one of the oldest laboratory shows and still one of the largest US exhibitions we attend. The 2019 format, held at the Philadelphia Convention Center, was similar to last year with a five-day technical program and a three-day exhibition. Many US Labs, large and small, find PITTCON a great place to research LIMS. They are able to compare the main vendors in-depth over the course of the three days and get to understand them enough to make some initial choices and guide their future decisions over user requirements. Unlike in previous years there was no “Informatics” section, so those doing the research had to search out the LIMS vendors from the exhibitors.
Industry-leading enterprises have tended to invest heavily in laboratory IT initiatives to drive the innovation necessary to stay competitive while improving laboratory efficiency. These organizations deploy applications for all the right reasons – reduce costs, improve organizational efficiency, drive innovation. Unfortunately, application bloat is an all too common occurrence across large organizations.
Building a Smart laboratory involves a multi-disciplinary approach and a commitment to move away from traditional paper processes. Many day-to-day, routine laboratory operations are still carried out using manual, paper-based systems for everything from recording test results to managing inventories to documenting and scheduling instrument calibrations. This reliance on paper is not just expensive, it also decreases the efficiency of the laboratory workplace and leaves the laboratory vulnerable to having valuable data misplaced, lost or destroyed.
Technological advancements in wireless networks, laboratory equipment, sensor technologies, micro-electronics, informatics software and other areas have helped to spawn a digital revolution in connectivity in the modern laboratory. Forward-thinking organizations are capitalizing on this digital revolution to create highly integrated and automated smart laboratories that help facilitate product quality and efficiency in manufacturing processes, as well as enhanced innovation and product development through data analysis, process monitoring and continuous feedback.