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.
Configuration management is an important aspect of PLM. Ensuring all parts and components are well-documented within a BOM can prevent costly mistakes. Let’s explore how Windchill enables successful configuration management. What You Will Learn In this eBook you will...
Cloud migration and modernization are essential for businesses looking to remain competitive and achieve cost efficiency. Microsoft Azure has emerged as a leading cloud platform, offering robust infrastructure, scalability, and security to its users. It is an...
Effectively managing software licenses can be challenging, but it is critical in ensuring your organization works cost-efficiently. These challenges only increase when vendors make unexpected changes. This was precisely the case when Klocwork, a leading static code...
In any company, the creation/delivery of the product or service and the sale of it are top of mind for the CEO. This is the lifeblood of the business. As such, it is critical to have metrics that clearly communicate the health of product creation and release. A CEO...