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I guess by now the rumors are true and the FDA has recently (late 2015) announced that it will begin much more stringent inspections for compliance to 21 CFR Part 11 regulations related to and concerning electronic records, audit trails concerning metadata, and signatures that need to be actual and trustworthy, plus validation of products.
By Peter Norton
Author: Peter Norton
Peter Norton is a senior logistics and supply chain manager and consultant to the life science industry, with extensive experience in both the domestic US and global markets.
View Peter's profile
The ICH and other globally focused organizations are working diligently to introduce more consolidated forms of quality regulations, like the ICH Q10, for the management of the quality of drugs related to cold chain distribution and drug security.
It is now approaching 2 years since the Chinese FDA began a push to adopt their proposal for regulations around Good Supply Practices (GSP) within China.
Although these regulations closely mirrored the EU GDP guidelines, and were focused on a ‘risk approach’ to managing quality, the expectation is for full adherence of these new regulations by the end of 2015.