Study Sites: Too Many Vendors, Too Little Time

Clinical site employees are dealing with  more tech vendors than ever before,  consuming  time that should be spent  running the study,  wor...

6 Lessons that Quality Managers Can Learn from ‘Star Wars’

by David R. Butcher Marketing Communications, MasterControl Beginning with A New Hope nearly 40 years ago, characters in the epic  Star War...

eTMF Management: Don’t Settle for a One-Trick Pony!

When you search for an electronic  master file (eTMF)  solution, be sure it  is versatile and not a one-trick pony! by Patricia Santos-Serra...

6 Military Skills Highly Valuable to Manufacturers

This Veterans Day, employers should  consider the valuable skills and attributes typically shared by most U.S. military vets. by David R. Bu...

Training Effectiveness – A Quality by Design Approach

You can provide all kinds of training  for your employees but how do  you measure its effectiveness? By Holly DeIaco-Smith, MS  HDS Consult...

Hacking GMPs: Deliberate Attacks or Accidental Workarounds?

Can't find the right lid for the barrel?  You might find  a different lid that almost fits and use duct tape. But if  you do,  chances a...

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...

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...

7 Ways to Reduce Human Error on the Drug and Device Manufacturing Floors

Human error is responsible for more than  80 percent of failures and defects.  by Ginette Colazzo President of Ginette M. Collazo, Inc. Huma...

How to Tip Off a GCP Auditor in 25 Words or Less

"Jane, quick!  The auditor's here!  What's an SOP?" by Laurie Meehan Social Media Manager Polaris Compliance Consultants “...

Your Biggest End-User Training Problem—Solved!

E-learning makes it easier to  train your global workforce. by Donna Cline, Senior Instructional Design Specialist, MasterControl   Accordi...

5 Practices for Managing Change When ISO 9001:2015 Arrives

For any organization that will need to transition to the new ISO 9001:2015 standard, the time to start planning is now. by Terrance Holbroo...

Data Integrity Starts With User Access

User access to databases can impact data  integrity and get you in trouble with FDA. by Jamie Colgin Colgin Consulting Reprinted with permis...

Four Reasons to Automate SOP Management in FDA and ISO Environments

In FDA and ISO environments,there are multiple  reasons to consider automating SOP management. by David R. Butcher,  Marketing Communication...

7 Document Management Blunders that Jeopardize Compliance

Is bad document management spoiling  your compliance efforts? Learn how  to fix seven common document  management mistakes. by James Jardine...