Data Integrity – Audit, Plan, Train LIMS & Laboratory Systems Validation Planning & Training
Mark Newton, Heartland QA Principal, has 34 years of experience in pharmaceutical laboratories, lab systems, LIMS, QA and computer systems. He authored the first corporate remediation for qualification of computerized analytical equipment in GMP Laboratories, and led corporate remediation efforts for security of lab systems.
Latest Posts
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.…
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.…
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