NOTE: This article originally appeared in Research Information. It can be found here: https://www.researchinformation.info/news/analysis-opinion/research-‘misconduct’-will-be-big-very-big Research ‘misconduct’ will be big… very big9 August 2018Research misconduct – and other integrity issues – are poised to become a major issue for research publications, eventually forcing major changes in the way laboratory data is summarized, reviewed, and retained. GreaterContinue reading “Research ‘Misconduct’ Will Be Big….Very Big”
Monthly Archives: September 2021
Simple Strategies to Reduce Human Errors
Like you, I have read many articles about human errors: how often they occur, the types of errors people create, etc. Basically, we thoughtfully design processes and systems, then mess them up with these humans inserted into the process. But the simple truth is that humans are also superior to automation in some forms ofContinue reading “Simple Strategies to Reduce Human Errors”
Document Review/Approve: When Less is More
I wrote earlier about the front-loaded nature of Quality. On the back end of that process is reviewing and approving documents prior to their use for regulated activities. When assessing the quality culture of an organization, one thing I note is the number of review/approve signatures on a document. Immature organizations have MORE signatures than mature organizations.Continue reading “Document Review/Approve: When Less is More”
What LIMS/ELN Will Not Do For You
Let’s start by making it clear that there are many things an electronic management system can do to improve your laboratory: a good system, properly configured, can deliver lots of efficiency gains, data integrity improvements, record controls and data sharing through the organization. It also becomes a source of data for company-wide analytics and monitoring.Continue reading “What LIMS/ELN Will Not Do For You”
Depressed By Spreadsheets
If you have not read some of Professor Ray Panko’s work, you are missing out. Some fellow GAMPers told me about him several years ago, while working on the GAMP Good Practice Guide for Computerized Lab Systems (1). His specialty is human errors in spreadsheets, mostly focused on Sarbanes-Oxley and “material errors” But his workContinue reading “Depressed By Spreadsheets”
Quality is Front-Loaded
One of the challenges for young organizations is developing a “feel” for quality. It’s a subjective thing. After participating in activities done well, you develop a rhythm-an inner sense that things are flowing as they should (or not). Call it a “gut feel” if you will. One of those “gut feel” items that I lookContinue reading “Quality is Front-Loaded”
All About the Transition
The title of this article might seem unusual, but it is true—and fundamental to most companies who make/market/sell pharmaceuticals and medical devices. You see, when it comes to improving data integrity, there are two basic approaches: (1) create a program office to lead the data integrity improvement efforts—I call this the Quick Hit approach; (2)Continue reading “All About the Transition”
Validation Is Risk Management
I have been actively involved in computer system validation activities since 1995 and have witnessed the maturity of validation from the early days of “what does validation mean?” to the current standard of GAMP 5. During the industry shift toward Quality risk management (QRM) that was brought front and center with the FDA’s report “PHARMACEUTICALContinue reading “Validation Is Risk Management”
Blockchain is Not Your Savior
Blockchain has gotten lots of buzz in the past couple of years, and with the announcement that Amazon (along with other major players) is making it simpler for companies to adopt it, the buzz will only increase. I attended the Paperless Lab Academy in Milan earlier this year, and blockchain was discussed as an emergingContinue reading “Blockchain is Not Your Savior”
Welcome
Originally published by Mark Newton (Principal) on 11 May 2018