My eQMS Consultant is Gone—Now What? 4 Post Go-Live Survival Tips

As users begin to learn the software, they will  have lots of questions. Will you be ready?   by Stephanie Jones, Senior Professional Servic...

Three Keys to Successful FDA Inspections – Preparation, Management and Follow Up

Preparing for an inspection will help ensure a smoother,  less stressful experience. A mock inspection is a useful practice tool. by Kelly T...

Quality Event Investigations, Interviews, and Brian Williams

When you investigate a quality event,  do you conduct an interview  or an interrogation? by James L. Vesper, PhD, MPH LearningPlus If you ar...

European Supply Chain: A Series of New Regulations in Force

The new GDP Guidelines apply to the  wholesalers and manufacturers of  pharmaceuticals and incorporate  specific requirements for Brokers de...

Get Products to Market Sooner by Systematizing Quality Cycles

Getting  a product to market is not a one-time event—it involves a series of cyclical processes. Is every phase along your organization’s o...

eMDR Compliance Deadline Looms: Last Minute Tips for Procrastinators

 Beginning August 14, 2015, device makers must  submit all medical device reports electronically. by Alex Butler, Product Manager Life Scien...

Don't Just Fix It: Find It Before Your Customer Does

When mistakes happen in your  company,  who takes the blame? by Anna Thornton Analytics Operations Engineering It is human nature to find a...

Ensuring Proper Training for Clinical Research Staff in Less Time

Many clinical research associates spend as much  as 75 percent of their time on the road.  by Sandra Maddock President & CEO, IMARC Res...

It’s Hot in Here—Quality, Compliance, and Romance

Whether in quality systems or in life,  don’t fall for the gorgeous bad boy.  Aim for long-term compatibility. by  Cindy Fazzi Editor, Maste...

From Open Payments to OpenFDA, the Push for Global Transparency is Accelerating

Transparency leads to happier patients,  better trials and lower costs, advocates say.   by Lisa Weeks, Marketing Communications Specialist,...