For pharmaceutical and medical device manufacturers, computerized systems validation is vital. The following are three areas businesses must fine tune to ensure computerized labeling systems meet the stipulations of the new GxP regulations.
Moving too quickly in the product development process can lead to mistakes.
The agency stated that Battelle Memorial Institute is not in compliance with reporting requirements related to its CCDS.
Across Asia, government health and safety authorities have tightened regulations on medical devices this year, as markets continue to experience rapid change, and as the devices themselves gain sophistication and complexity at a blistering pace.
Although medical device manufacturers have more time to prepare due to the delayed EU MDR deadline, this shouldn’t distract from the extensive documentation they must compile in the meantime to prove their devices are compliant.
Digital technologies offer more efficient and patient-friendly distribution of the up-to-date manufacturing details and safety advice mandated by regulators. But many firms in the medtech sector are not maximizing the opportunity to deliver regulated product information digitally.
Whatever the short- and longer-term fallout of COVID-19, organizations will need to come back fighting—with new tools at their disposal and ready to raise their game.
A lot of promises are made by organizations about making systems more intuitive, convenient and user-centric, but in reality most improvements tend to be designed to meet regulatory or internal system needs rather than better serve the people who use them. The user experience needs to be modernized, especially in heavily regulated industries where inaccurate or non-compliant labeling is laden with risk.
Timely compliance will ensure that your products will not be considered misbranded.
As the saying goes, if it looks too good to be true, it probably is.