Research ‘Misconduct’ Will Be Big….Very Big
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. Greater…
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 of…
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.…
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About Me
Mark has 34 years of experience in pharmaceutical laboratories, lab systems, LIMS, QA and computer systems at Eli Lilly and Company. He helped design and support an enterprise LIMS system, including user training and custom reports. For several years, Mark was an instructor for corporate courses for Validation of Computer Systems, and worked on teams that created validation deliverables. He authored the first corporate standard for qualification of computerized analytical equipment in GMP Laboratories, and led corporate remediation efforts for security of lab systems. He co-authored and trained lab personnel to identify and assess data integrity gaps in laboratory processes. He has nearly 20 years of experience in validating computer systems, from laboratory benchtop systems and spreadsheets, up through enterprise LIMS and SAP systems.
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