Consumer Product Manufacturing: Greater Communication and Credibility Through EQMS

It’s common practice for many companies in the consumer products manufacturing space to outsource their manufacturing, packaging, and purchase of raw materials to suppliers and contract vendors around the globe. Despite their best efforts to increase profit margins by tapping … Read full article

What is CAPA in Medical Device Quality Management?

In the event of a product safety or functional failure or complaint, a CAPA system can help medical device companies to identify trends and what has happened in the past, as well as determine a path of remediation. These systems … Read full article

Wearable Devices: When Purpose is More Than Just Fashion, Quality and Compliance are Not Optional

When we think of wearable devices we usually think of watches, or goggles. Well, these smart watches do more than just tell time or weather or incoming caller ID, and the goggles do more than project some image in our … Read full article

The Rise of Quality Metrics

Guest Author: Jing To | Director, Product Marketing, R&D | Veeva Systems The theme for DIA Annual 2014 was to celebrate the past and invent the future. And it looks like the future is a more stringent FDA, requiring more … Read full article

What Impact Does the Recent ICSR Guidance Have on Your Pharmaceutical Company?

On June 10, 2014, the FDA issued a final ruling modifying submission requirements for Individual Case Safety Reports (ICSR).  The modification requires pharmaceutical companies submit the adverse event data electronically through the FDA gateway.  Previously companies had the option of … Read full article

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Bruce KratzBruce Kratz VP of Product Development

Bruce Kratz is the VP of Product Development at Sparta Systems where he is responsible for all Research & Development activities. Mr. Kratz has a successful track record of leading enterprise software teams and has close to 25 years of product development experience. Prior to Sparta Systems, Mr. Kratz was the Director of Development at IBM where he was responsible for product business plans for a portfolio of over 300 IBM Data Governance products. VIEW ALL PROFILES

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