News

ISPE Packaging Validation Discussion Paper

By Erica Stolz The International Society for Pharmaceutical Engineering (ISPE) recently published a new Packaging Validation Discussion Paper.  The paper is intended to help bridge a gap spanning between manufacturing process validation and packaging process...

4 Steps to Successful FDA Change Management

By Vonda Ashley Change management is one of the key elements to a quality system in the pharmaceutical industry. Most pharmaceutical companies understand the need and purpose for change management as an overall concept and have a system(s) already in place to manage...

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...