This new series of four articles takes a look at the UK’s Medicines and Heathcare products Regulatory Agency (MHRA) guidance for industry on data integrity. The focus of these articles is an interpretation and critique of the second version of the MRHA data integrity guidance for laboratories working to European Union GMP regulations, such as analytical development in R&D and quality control in pharmaceutical manufacturing.
Over 75 percent of a laboratory experiment or analysis starts with some kind of manual process, such as weighing. The majority of the results of these measurements are still written down manually on a piece of paper or re-typed into a computer or tablet. ELN and mobile devices like tablets are married to each other. However, to connect a balance, you need to be an IT professor...
On April 15, 2014, a Wilmington, DE, business owner, was driving home on the I-495 bypass, as he had done for 25 years. While traveling on the twin three-lane bridges that span the Christiana River, he noticed that the normally parallel bridges were offset by nearly 18 inches in height and the apparent listing of one of the lanes had created a large gap between the bridges through which the ground was visible, some four stories below.
Much of the world’s industries are affected by weather. UBIMET is one of the world’s leading private weather service providers. The company offers a range of precise, real-time micro-climate forecasting and alerts, historical weather data, and other services to several million customers around the globe. UBIMET’s competitive advantage lies in the complex character of their solutions and depth of their science and technology.
Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 4: System Design, Definitions and Overall AssessmentMay 29, 2015 1:56 pm | by R.D. McDowall, Ph.D. | Comments
This is the final part of a series reviewing and critiquing recent MHRA guidance for industry on data integrity. The first part of the series provided a background to the guidance document and discussed the introduction. The second part reviewed the data governance system, and the third part discussed data criticality and lifecycle. This part reviews the system design, some of the definitions, and finishes with an overall assessment.
Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 3: Data Criticality and Data Life CycleMay 29, 2015 12:21 pm | by R.D. McDowall, Ph.D. | Comments
This is the third of a four-part series reviewing and critiquing the recent Medicines and Healthcare products Regulatory Agency guidance for industry document on data integrity. The first part of the series provided a background to the guidance document and discussed the introduction to the document. The second part reviewed and discussed the data governance system. In this part, we will look at data criticality and the data life cycle.
Review and Critique of the MRHA Data Integrity Guidance for Industry — Part 2: Data Governance SystemMay 29, 2015 11:27 am | by R.D. McDowall, Ph.D. | Comments
This is the second of a four-part series reviewing and critiquing the recent Medicines and Healthcare products Regulatory Agency (MHRA) guidance for industry document on data integrity. The first part of the series provided a background to the guidance document and discussed the introduction to the document. In this part, we will look at the MHRA requirement for a data governance system.
This new series of four articles takes a look at the new UK’s Medicines and Heathcare products Regulatory Agency (MHRA) guidance for industry on data integrity. Topics in this introductory article include global data integrity problems, the MHRA approach to data integrity, a MHRA data integrity guidance overview, and an introduction to the MHRA guidance.
The real benefit of laboratory information management systems (LIMS) is difficult to calculate. Let’s take a look at some key considerations, starting with the question of whether to build the LIMS yourself or buy a commercial LIMS… Advocates for building a new LIMS themselves usually state that their lab is so unique, they cannot use a commercial LIMS. However, very few labs are truly unique ...
Scientific Computing periodically features special informatics focus articles that attempt to help you with such complex tasks as selecting a laboratory information management system or interfacing systems together. Unfortunately, there is only a limited amount of information that one can cram into one of these articles. Where we are limited to just a few pages for each of our attempts, Joe Liscouski has written a whole book on the subject
On a telescope at the summit of Mauna Kea in Hawaii, it’s not easy to put in a full night of work. At 14,000 feet, you’re operating at only 60 percent of the oxygen available at sea level, which makes concentrating difficult. Top that off with a shift that begins at 6:30 pm and ends at 6:30 am, and it becomes hard to imagine astronomers working like that year-round. Luckily, most of us don’t have to.
Today's LIMS allow research institutions to monitor and manage a broad array of biomedical research processes end-to-end and remotely. But how do they accommodate the ongoing flood of discoveries in areas such as genetics, the -omics, regenerative medicine and behavior, ongoing adjustments to workflows and protocols, tens of thousands of animals, and the evolution of legislative, welfare quality, and ethics directives?
These days, using a LIMS seems to feature in every scientist's life, and for some small and medium-size labs, open source code is the way forward with a LIMS. In fact, businesses have grown up around helping labs implement open source LIMS and learn to make modifications in house. A bridge too far for a nonprofessional? Not according to Greg Wilson, who believes that most scientists can easily learn enough to slip into coding...
Quantum Computing has been a concept since the 1980s that has remained outside the domain of real-world HPC. Through the era of Moore’s Law and exponential progress in feature size, clock rates and resulting performance, the need for alternative paradigms and technologies has attracted little interest. But there has remained a curiosity among a limited community that has driven slow but persistent advances in associated ideas.
All the computing power in the world isn’t useful if the software designed to access it is poorly designed. And we’re all much more discerning about user interfaces and usability: we expect our laboratory software to behave as intuitively as our smartphones. After all, laboratory employees are unlikely to be preoccupied with lines of codes and processors — they’re focused more on how easy the software is to use.