Media Coverage

FDA’s medical gas guidance offers clarity to manufacturers

FDA’s new draft guidance on current good manufacturing practice for medical gases closed for commentary in August. The revised draft guidance details the current good manufacturing practice (cGMP) requirements for medical gases, superseding an earlier draft guidance from 2003
September 2017


Medtech complaint handling: Is there something to complain about?

Medtech complaint handling appears to be a work in process, according to Sparta Systems’s recent quality management market survey.
September 2017


5 mistakes that can turn your product registration into a money drain

Medical device registration may seem straightforward but is actually prone to potentially costly mistakes. 

Medical device organizations are required to register medical devices with notified bodies in all countries where they sell those products. This process is fairly well understood and expected.

However, there are pitfalls in the practice of compiling the dossiers to register, and mistakes can end up costing a company money, according to Carl Ning, director of global solutions architecture for Sparta Systems (Hamilton, N.J.).  September 2017

Sparta Systems Case Study

Sparta Systems decided to run its Stratas quality management platform on Amazon Web Services (AWS). “A lot of our customers in the biopharma and medical-device industries had already started to use Amazon for GxP and non-GxP workloads,” says Kratz. “That history is meaningful. We believe AWS is well ahead of its competitors when it comes to working with life sciences industry leaders to ensure their services meet regulatory scrutiny.”
July, 2017

Is Deregulation the Only Answer to Getting More Affordable Drugs to Market Faster?

Earlier this year, in his first address to Congress, President Trump criticized the FDA’s drug approval process saying the length of time in which drugs need to be approved is “slow and burdensome.” Joe Goodman, Director of Solutions Consulting at Sparta Systems, weighs the potential outcomes of deregulation to examine whether it is the only means by which to quickly introduce new and affordable medications.
July, 2017

How cloud-based IT systems address FDA validation requirements

The life sciences community has always been more conservative when it comes to the adoption of new technologies, and cloud-based systems are no exception. 
June, 2017

Still Struggling with Quality Metrics?

The importance of quality management cannot be overstated. It enables companies to increase efficiency, lower risks, achieve compliance, and build better and safer products. Yet many quality management teams struggle to communicate the value of their operations to other departments and executive leadership.
May 2017

3D Technology Emerges

With the FDA acknowledging 3D printing as an important emerging technology in the pharmaceutical industry, David Hess, Technical Solutions Consultant at Sparta Systems, explores the impact, benefits and risks of 3D drug printing.
May 2017

Medical device reporting: Reading between the lines

Late last year, the U.S. Food and Drug Administration released the final guidance on Medical Device Reporting (MDR), a critical quality component of a company’s complaint management system. 
April 2017

The Most Important Question to Ask About Your Audit Program

Just inside the entrance to Thomas Edison’s winter home in Naples, Florida, is a bronze bust of Edison himself. The base of the sculpture reads: “There is a way to do it better—find it.” As an accredited auditor of management systems and good manufacturing practices (GMPs), I have always seen curiosity as the trait that makes for a successful auditor and a successful audit.
March 2017

3D Printing Meets Pharma: Reward & Risk

3D printing technology not only offers great potential to create drugs that are easier to consume and more effective, but also potential efficiencies throughout the research, development, and manufacturing process—even the supply chain.
March 2017

Data Integrity in the Medical Device Industry

Improving patient safety is at the heart of the medical device industry, but many manufacturers may not realize that this starts with data integrity in the manufacturing process. 
March 2017

Sparta goes all-in on cloud-based quality management systems

Pharmaceutical Commerce talks about the benefits automated validation for regulated industries.
February 2017

ISO 9001:2015 and Supplier Quality Management

The year 2017 is finally upon us, so Happy New Year one and all! For many, it will take a little while to get used to this turn of the calendar. Others however, particularly in the quality space, may already have their eyes on 2018.
January 2017

Lessons learned from a cookie dough recall​

Earlier this fall, several major brands voluntarily recalled products due to potential listeria concerns in cookie dough ingredients. 
January 2017

Medical device reporting: your burning adverse event questions answered

In November 2016, FDA released its final guidance on medical device reporting (MDR). MDR has been an intrinsic part of the medical device regulatory process for many years. There’s no specific change or new information in this document, but it does answer some fundamental questions about when and how to do things. It is organized as an FAQ-style reference, to be used in conjunction with online Medical Device Reporting requirements and guidelines.
January 2017

Preparing for IDMP Compliance – What you need to know

Beginning in early 2017, life sciences organizations that intend to manufacture and/or market medicinal products within the European Union will be required to comply with the Identification of Medicinal Products (IDMP) regulations, a global framework for identifying medicinal products, set forth by the European Medicines Agency (EMA).
January 2017

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