ELECTRONIC REVIEW: easy to manage with Ioi – Integration of instruments

inpharmatic post

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

inpharmatic 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

Academy training PLA2020

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. […]

GLIMPSING THE FUTURE OF DATA INTEGRITY

data integrity GMP MHRA

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 […]