API Findings Upgraded and Downgraded

Effective Handling of API Nonconformities and Concerns Understanding API Findings Changes API findings can change after internal closure. Concerns may be upgraded to nonconformities, and nonconformities may be downgraded to concerns. We have seen this happened to more than one client. Without clear guidance, internal tracking can become confusing and inconsistent, let alone responding to […]
Five Key Trends to Watch in 2018

The rules are changing and time is short. If you are a manufacturing company or a service provider, there is a good chance that you have heard about standards such as ISO 9001.
API Specification Q2 Training: For One and For All

Imagine this: It’s the end of the year and it’s vital that you receive API Q2 training immediately. But there is a problem. Everyone is celebrating the holiday season…
Document Control 101: How to comply with ISO and API without being trapped by your own words

Sometimes the interpretation of the ISO 9001 or API Q1 9th Edition/API Q2 requirements seem to force us to do things we won’t be able to do, or sustain for more than a few months— let alone days…