AssurX Blog
Straight talk for regulated industries.
FDA Gives MDDS World a Big Break
Sometimes it’s nice to be told what the FDA isn’t going to do. The agency issued a guidance last month that should give anyone building or working with a Medical Device Data System (MD [...]
There’s No Such Thing as HIPAA Certification: 4 Myths Surrounding Hosting Providers
Ron Shoop, SVP, National Sales Manager & Strategic Alliances, Medical Web Experts As more physicians are integrating their patient EMR with third-party patient portals, they’re l [...]
Training Management Best Practices for Emerging Life Science Companies
Jeff Mazik, Vice President, Life Science Solutions, AssurX No matter how good your written policies are, or how clean a facility you operate, or how successful you are in the marketp [...]
Quality Takes Time, FDA’s CDER Reminds Drug Makers
Michael Causey, Editor & Publisher, eDataIntegrityReport.com Scholars still debate how long it took to build the Great Wall of China, but it’s generally agreed it was built in st [...]
FDA’s CDRH Guidance Tempers 2015 Goals with a Dash of Pessimism
Unlike its sister Center for Drug Evaluation & Research (CDER), CDRH’s (Center for Devices & Radiological Health) new proposed guidance development and goals for 2015 reminds [...]
FDA’s CDER Unveils Ambitious 2015 Wish List
The holidays came a little early for the folks at the Center for Drug Evaluation and Research (CDER). They just released their sometimes optimistic, but always enlightening guidance wi [...]
