GxP Lifeline Pharmaceutical Publication Click to visit GxP Lifeline Home Click to visit mastercontrol.com

Featured Articles

December 2011

Stephen F. DeAngelis

End-to-End Supply Chain Visibility: It's no VUCA-tion for Supply Chain Professionals

by Stephen F. DeAngelis
Technology and Supply Chain Sector Entrepreneur, Enterra Solutions, LLC

In a survey conducted by ChainLink Research, pollsters found that "the vast majority of respondents (nearly 80 percent) do not manage risks beyond their immediate first-tier suppliers. Instead, they rely on their immediate suppliers to manage those risks." With so many well-respected supply chain analysts talking about the importance of developing end-to-end supply chain visibility, 80 percent seems like a big number of non-believers. Perhaps it is the phrase "managing risks" that causes that number to be so high. After all, having supply chain visibility is not exactly the same thing as managing risk. Regardless, I suspect that most supply chain analysts would tell respondents who fall into the 80 percent group that they are being shortsighted. Enterprise strategist, Lora Cecere, believes that companies need to develop "value networks that extend from the customer's customer to the supplier's supplier, and that [they need to] sense, shape and respond by listening, testing and learning with minimal latency."

Read more

Christine Park

Is Your Executive Management Team as Involved with Your Quality System as They Should Be?

by Christine Park
Christine Park & Associates

We've all heard of the recent FDA decision to increase the focus of inspections on management with executive responsibility. There have been at least two warning letters issued this year with observations targeted in this area. While there are 26 references to the role of executive management within the Quality System Regulations (QSR 21 CFR820) these warning letters address two very basic requirements of quality systems.

These two examples (see article) are obviously blatant and send a strong message. Now is the time to step back and re-evaluate the role your executive management team is playing in your own quality system.

Read more


Featured Webinar:

Featured White Paper:

Previous Newsletters:

Watch Customer Videos

View Upcoming Events

Did You Know?

Cphl Japan
March 21-23, 2012, Tokyo, Japan

April 17-20, 2012, Munich, Germany

SQA Annual Meeting
April 24-26, 2012, Miami, FL

May 1-3, 2012, New York, NY

May 21-23, 2012, Anaheim, CA

View More Events

Did you know that you and your colleagues can remotely access vital documents, complete pending tasks and collect critical data from smart phones and tablets by using MasterControl Mobile™? Documents, tasks and data can be accessed from around the world, from just down the hall, in the lab, or on the shop floor. MasterControl Mobile can set you free!
Read More