In the excitement of a new project, it is tempting to get into the purchase and implementation of new equipment and systems in a rush to meet your tight timelines. But...take a breath. You have already performed some sort of…
Wow! There are a TON of CMMS software companies out there! But if you are in an FDA regulated company (e.g. pharma, biotech, medical device, etc) then your choices are MUCH more limited. If you go to a site to…
It's not just drug, medical device, and bio-tech companies that are keeping their operations GMP compliant. Manufacturers of legal Cannabis and CBD related products are joining their ranks and progressing quickly. As the industry matures, companies are getting their plans…
Most companies, when they get to the point of putting a Computer System Validation (CSV) and/or Data Integrity program in place, have many systems already deployed. Often a mix of business, scientific, manufacturing, building management and tracking systems. In addition,…
As consultants, we usually get called to add a little horsepower to an effort already under way to mitigate some issue, whether it is performing gap assessments and remediation or adding resources to speed up resolution of some problem. Sometimes…
There are a great number of ideas out there in academia with medical applications. Of course, this is not new. My first exposure was to a medical device at UCSD being developed not long after the public availability the DOS…
Just a short note to potentially save a big headache: Haveibeenpwned.com is a site that tracks if your email has been found to be on lists of known hacked databases. This can be very useful in preventing a person from…
Our new web site is launching for Q3 2018. A great update from our previous site. Please check back for upcoming Events!