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

CAPA and Discrete Manufacturing Process Flow: More Than Just Corrective Action

Corrective action encompasses more than just corrective action; it refers to both corrective and preventative action (CAPA). In the area of discrete manufacturing — and the automotive industry, in particular — manufacturers must take specific steps to remedy a problem … Read full article

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Since 1994, Sparta Systems, Inc. has advocated the need for accountability and control of work-flow processes, along with clarity and transparency. Our experience in highly regulated industries is unmatched, as is our commitment to providing visibility of mission-critical attributes from a centralized system through a global process.

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Joe HummJoe Humm Director, Global Sales Operations

Joe Humm is a senior member of the Sparta Systems sales team, leading up the Global Sales Operations team. Joe has a wealth of experience in the CPG industry; in enterprise solution value messaging and sales processes; and in important technology trends such as Big Data, Analytics and SaaS. VIEW ALL PROFILES

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