The FDA is allowed to visit your company to perform an inspection. In the course of the visit they may bring some issue to your attention in the form of an observation (aka a 483). This article reviews what a 483 looks like, some of the more common issues flagged in medical device companies, and how to respond.
We invite you to download our paper on the topic of 483 Observations.
Asset management is an important aspect of ITSM. Discovering the best way to manage yours can greatly increase your business’s efficiency. Assets in Jira Service Management allow organizations to manage hardware, software, facilities, people, and more. What You Will...
The digital landscape is constantly changing, leaving businesses scrambling to adapt to new technologies and processes. Tools once used as the backbone for these businesses are now outdated. Legacy systems are a perfect example of this. Although they used to be...
SCOTTS VALLEY, CA - Engineering and IT leader SPK and Associates is pleased to announce its achievement of SOC 2 Type 1 certification. The SOC 2 Type 1 certification attests that SPK’s information security meets or exceeds the rigorous standards set forth by AICPA....
Mergers and acquisitions (M&A) represent a major growth strategy for many companies, particularly in the technology, manufacturing, and engineering sectors. However, integrating two (or more) companies is never a simple task. The challenge is not only in...
