Can a DeltaTrak PDF data logger become infected with a computer virus? To answer this question, let’s take a look at what is a computer virus, based on what it does: 1) It attaches itself to computer files (i.e. applications, documents and procedures); 2) Once opened, it gives a computer a set of instructions; 3) It replicates itself; 4) It carries a malicious function, such as changing/corrupting files, or accessing passwords. As we can see, a computer virus is largely defined by how it functions.
Did you realize that DeltaTrak can serve as your one-stop shop for calibrating all of your DeltaTrak products?
For years, customers have turned to the calibration and certification services offered by DeltaTrak. All DeltaTrak calibration is completed using high quality measurement instruments certified against National Institute of Standards and Technology (N.I.S.T) by a primary standards laboratory.
As the regulations for food and pharma' get closer together in nature an overarching guidance is emerging which is related to risk aversion and risk mitigation planning.
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.
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.
When any QA department turns their attention to data and security most of the focus is on how this is controlled internally in relation to common regulations like - 21 CFR Part11, Part 820, GMP, etc., and of course patient data regulations like HIPAA.
In March of 2013 in the EU the EMA introduced a new guideline related to Good Distribution Practices (GDP) and in June of 2013 the Chinese FDA introduced a new guideline related to Good Supply Practices (GSP).