December 2014 Posts

7 Ways Life Sciences Executives Can Help Foster a Quality Culture

7 Ways Life Sciences Executives Can Help Foster a Quality Culture

Matthew Littlefield, President & Principal Analyst, LNS Research

Nearly every executive responsible for quality and compliance in life sciences has the topic of culture on their mind. Why? Because in an industry driven by innovation, deep down it’s the people — the scientists, the engineers, the shop floor workers — that separate one company from another. And having a culture that puts quality and compliance first can be the foremost source of differentiation.

Although many executives understand the importance of a quality and compliance-based culture, few have actually been successful in developing their own. Our recent Quality Management Systems survey verifies this, revealing that 30% of life sciences executives feel their organization considers quality much more of a single department rather than an organizational responsibility. (more…)

Medical Device Single-Audit Pilot: Will it Fly?

Medical Device Single-Audit Pilot: Will it Fly?

Sandy Carson Hessen, Marketing Communications Manager, Pilgrim Quality Solutions

We’ve all seen them. Some flop, some fly. Television Pilots — stand-alone episodes of television series used to sell shows to the networks by gauging whether a series will be successful. After seeing this sample of the proposed program, networks then determine whether the expense of additional episodes is justified.

There’s another type of pilot airing right now in the Medical Device industry, and the purpose is similar. (more…)