News

Clarke Solutions Will Exhibit at Interphex 2018

Fishers, IN – Clarke Solutions, an industry pioneer in providing field-tested services in packaging, automation, validation, and serialization, will be exhibiting at the Interphex 2018 trade show at the Javits Center in New York City from April 17-19, 2018. In Booth...

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...