Category: Data Integrity
Digital Data Management discussions at the live edition of PLA2022Europe
The Paperless Lab Academy® 2022 Europe promises to be even more exciting than previous editions. More exciting definitely than last virtual ones as the human interaction component, all healthy measures observed, will bring us all back together. Hence, let’s keep on focusing on digital data management, but not digitally this […]
From Raw Data to Artificial Intelligence
The Program of the next coming edition is getting pretty framed and we’re glad to share with you, that once again the presentations and discussion will cover the Data Life Cycle from Raw Data to Artificial Intelligence. The Paperless Lab Academy® works in providing the audience food for thoughts in […]
ELECTRONIC REVIEW: easy to manage with Ioi – Integration of instruments
Renewed attention of the authorities inspectors to the Data Integrity The QC laboratories work in a highly regulated environment where effective electronic data management processes ensuring Integrity are a must. Therefore, these processes are still largely based on paper, preventing efficiency improvements that could be really useful. The renewed attention of […]
How to solve legacy instruments Data Integrity gaps
Some instruments in the labs are not compliant to Data Integrity requirements At present, in the labs, there are still “legacy” measuring instruments, i.e. instruments that are there since ever and very often they’re not fully compliant to Data Integrity requirements. Usually, the remediation of their Data Integrity gaps is […]
Effective & Compliant Lab Informatics Implementation Projects
Benefit of a unique dedicated workshop about software vendor selection and risk management completing successful lab informatics implementation projects Transforming your laboratory and quality processes from paper-based to paperless ones require you to build on a very dedicated team for a lab informatics implementation and a very specific digitalization project. […]
Process Capability: The Missing Element to Data Integrity
A lot of attention has been given to the role that human factors play in eliminating data integrity failures within organizations. The ISPE Cultural Excellence Report (1) should be required reading for every organization that wants to better their data integrity and quality practices. But I want to introduce another […]
How to comply Data Integrity with simple instruments
After a Data Integrity assessment in the laboratories, the work ends with a remedial plan. One of the most difficult types of systems to be put in compliance are simple tools, such as scales, pH meters, conductivity meters, etc. For these tools, the guidelines consider acceptable that the data are […]
Qualification of Analytical Systems for Regulated Laboratories
Qualification of Analytical Systems for Regulated and Non-regulated Laboratories [Free Webinar: Wednesday, November 21th 2018 – 15:30 CET ] So many topics under one single line! Mark Newton is your expert to listen to when comes to understand compliance at the laboratory Presenting: Mark Newton, principal at Heartland QA […]
GLIMPSING THE FUTURE OF DATA INTEGRITY
GLIMPSING THE FUTURE OF DATA INTEGRITY: “MARK’S CRYSTAL BALL” by Mark Newton, Principal at HeartlandQA, mark@heartlandQA.com To a careful observer, the realm of Data Integrity currently has signals that indicate which direction the regulators—and hence, the industry—will be moving. My crystal ball is currently aglow with these future visions, in no particular order 1. […]
The future of the QC lab and its LIMS
Two big shifts in the focus of Lab informatics software are posing a challenge for the pharma industry. The first shift is due to the rise of the web and cloud-based services and their consequences regarding data management. The second axe of transformation is the increasing interest in process-analytic quality assurance as opposed to the end-product quality control that was […]