What to Expect from your First CMO Remote Audit
Remote quality audits (sometimes called “virtual audits” or “e-audits”) are replacing the in-person quality audits that have long been an integral part of selecting a
Category: QA/QC
How QSR-Compliant Medical Device Companies Can Switch to ISO 13485:2016
Preparing now for the switch to ISO 13485:2016 For decades, there has been a divide in the medical device regulatory landscape. While the U.S. Food
Looking to Gain Value in Your Drug Product or IVD? Level-Up Your QC Program
Many organizations view their QC program as a necessary evil- required by regulatory bodies and useful primarily to release product. However, defining and building a
Should I purchase an eQMS?
Establishing an electronic (or enterprise) Quality Management System (eQMS) is an expensive undertaking. So is it worth it? What is the value of having a