News

How to Streamline User Requirements

By Laura Reeve Reading and deciphering requirements in a wordy URS can be frustrating and cause complications for OEMs.  Clarke has generated a streamlined URS format that helps eliminate unnecessary words and uses an outline/indented format to present specific...

Importance of Planning in Project Management and Delivery

By Stacy Capek, Director of Engineering “There’s never time to do it right, but always time to do it over.”  How many times has this come to fruition while managing a project? Pressures of shortening the timeline and reducing cost seem to dictate project delivery time...

Change Management: Why You Need It & How to Do It

By Erin Hoffman, Lead Validation Engineer In the pharmaceutical industry, the change control process serves an important role. Although the cGMP regulation for drug products (21 CFR 211) has no direct reference to change control, it is implied in 211.100(a) and...

Will the FDA Regulate Your Mobile Medical App?

By Jon Wilderson, Senior CQV Engineer With the increase in wearable technology and a focus on managing medical related diagnostics with smartphone apps, it can be difficult to decipher if the FDA regulates your device. By answering the 3 questions below, you can...

5 Crucial Questions for Pharmaceutical Risk Management

By Ken Taylor, Pharmaceutical SME Pharmaceutical Manufacturing is one the most risk averse manufacturing environments in the world. The professionals who inhabit this sphere must be of the highest caliber, with world class manufacturing systems and facilities. Risk...

Kansas Team Supports Wildfire First Responders

Around 2,000 firefighters spent the weekend fighting fires in up to 23 counties in Kansas. In Clark and Comanche counties alone, more than 500,000 acres burned in the largest single fire in Kansas history. Our team in Kansas answered the call from their client site by...

Happy National Salesperson Day!

In honor of National Salesperson Day, we’d like to introduce you to Matt, a Sales Engineer on our team. We recently did a Q&A session with Matt to learn more about his favorites and to hear his best sales advice:   Q: What’s playing in your car...