Tag Archives: Sparta Systems

31Mar/21

Improving Product Quality & Patient Outcomes with Integrated QRM

An Axendia Insight Brief, Presented by Sparta Systems

An effective Quality and Risk Management program enables Life Science manufacturers to proactively manage product quality and patient safety. Risk management is a top priority for regulators around the world with a special focus on combination products and medical devices.

Through the use of an integrated Quality and Risk Management approach, manufacturers can achieve maximum value from their Risk Management program by deeply integrating it to their Quality Management System. In doing so, Life Science manufacturers can unlock process efficiency and enhanced signal and trend detection, leading to improved product quality and reduced patient risk. 

This Insight Brief, presented by Sparta Systems, delves into key points of an integrated Quality Risk Management solution where the ultimate result is improved safety and product quality, driving better outcomes.

To learn how an integrated Quality and Risk Management program can maximize the use of QMS data supporting enhanced Risk Management and mitigation and improved product quality that delivers the maximum benefit to the patient, register to request your copy below.

05Sep/19

Partnering with Customers to Make Digital Quality a Reality

Sparta Connection 2019 Event Brief

By: Daniel R. Matlis, President

The theme at this year’s Sparta Connection was: “Making Digital Quality a Reality.” Under the leadership of Dana Jones, CEO of Sparta Systems, the company continues to focus on customer success by delivering on commitments, ensuring transparency, and building relationships to earn customer trust.

“We’re 100% committed to putting customers at the center of everything we do, and to partnering with them to accelerate their transformation to digital quality,” said Ms. Jones. “We’re also committed to giving our customers maximum freedom, flexibility and choice by providing a range of options with our cloud, on-premise and hybrid options.”

Sparta Blog Image

To support its commitment to provide flexibility, freedom and choice to deliver quality based on customer needs, Sparta is investing across 3 dimensions:

  • TrackWise® QMS – Sparta announced their continued commitment to the TrackWise on-premise product for existing customers. They also announced that the next version of the product, TrackWise 10, will be coming out in 2020.
  • TrackWise hybrid solution – TrackWise customers can expand the functionality of their existing on-premise instances by seamlessly adding TrackWise Digital cloud modules to TrackWise. This includes cloud modules such as Complaints, Intake and Supplier Quality Management.
  • TrackWise DigitalSM – over 120 customer have selected TrackWise Digital

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14Aug/19

eBook: AI Drives Shift from Reactive to Predictive Quality

Regulatory Consideration for AI-Enabled QMS

Life Science companies must adopt Predictive Quality.  This eBook, sponsored by Sparta Systems, discusses how industry should leverage FDA’s Good Machine Learning Practices (GMLP) to implement AI in order to drive improved productivity and intelligent decision-making while meeting regulatory requirements.

AI EBOOK IMAGE 2“The ability of artificial intelligence and machine learning software to learn from real-world feedback and improve its performance is spurring innovation and leading to the development of novel medical devices,” said Dr. Scott Gottlieb, MD, 23rd Commissioner, US FDA.

The use of AI and ML can enable Life Science organizations to harness data and turn it into intelligent and actionable insights that enable predictive quality. AI systems can process data from point solutions to glean intelligence and  support decision-making.

In this eBook we also discuss:

  • Why you cannot validate AI with outdated CSV models
  • How AI is enabling the shift to predictive quality management
  • Implications for the Life Sciences industry

Register to receive your complimentary copy.

19Mar/19

eBook: Goodbye Computer System Validation…

Hello Computer System Assurance (CSA)!

By: Daniel R. Matlis, President and Ellyn McMullin, Research Associate

FDA supports and encourages the use of automation systems and digital technologies throughout the product lifecycle to improve patient outcomes and reduce the risk to patients. It is a common misconception that extensive testing and documentation is required to demonstrate the validation of computer software used in automation.

The FDA, recognizing industries CSV challenges, has announced new guidance on “Computer Software Assurance for Manufacturing, Operations and Quality System Software.” This guidance is on the Agency’s “A-list” and is planned for release in FY 2019.

The content is this eBook represents Axendia’s analysis and opinions on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” based on the following trusted sources:

  • Axendia’s interaction with FDA representatives on this topic
  • Content and material sourced from FDA
  • First-hand experience from Axendia’s clients on the implementation of CSA

Register to receive this eBook, sponsored by Sparta Systems, and learn:

  • Why Critical Thinking is the Foundation of CSA
  • How to Implement a Risk-Based Approach to CSA
  • The Objectives of CSA
  • What the CSA Landscape Looks Like
  • Acceptable Levels of Assurance

Webinar also now available on-demand:  Understanding the FDA’s New Approach to Computer System Validation.

 

 

04Oct/18

EU MDR – New Rules Require Greater Traceability, Data Transparency

Webinar Now Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

Compliance with Medical Device Regulation 2017/745/EU also commonly referred to as EU MDR, is presenting a significant challenge for the medical device industry.  Medical device companies are set to experience an enormous impact on all phases of the CE mark process including Design, Manufacturer Obligations, Evidence Collection, Conformity Assessment, Registration and Post Market Surveillance and Vigilance.

The schedule is aggressive – the rules will apply to some previously unregulated products and there will be no grandfathering of previously approved medical devices.  Controls on notified bodies that can approve the marketing of medical devices and the reporting on clinical trials will also be tightened.  Once devices are available for use on the market, manufacturers will be obligated to collect performance data to support tighter post-market surveillance requirements.  In addition, a new system will apply to in vitro diagnostic medical devices.

Concerns are quickly mounting throughout the industry.  We interviewed executives to determine what steps they were taking to prepare for the looming May 2020 deadline.  We heard:

  • “Older products will present a real challenge for us. 20 and 30 years ago, there weren’t many requirements for human factors, clinical trials and risk data”
  • “Our challenge is showing management what the cost is per product from a compliance standpoint”
  • “Imagine tracking down paper records for products from the 60s and 70s!”
  • “We will probably have to do a complete revamp of technical files to do resubmission”
  • “Our organization is behind on the IT curve. It will likely take three to four years to implement a robust global product data management system like that to support EU MDR”
  • “We are trying to get our business units to think about the systems as a platform….to execute against business processes which can be shared across organizations”

In a recent webinar sponsored by Sparta Systems, we discussed why Digital Transformation is a necessary journey for EU MDR compliance and beyond. The recording is now available on-demand.

It is important to note that MedTech Europe has issued a position paper asking the EU for a “stop the clock mechanism, that freezes the remaining transition time for both EU MDR and IVDR until full readiness of the system has been achieved.”  However, Med-Tech companies must begin to take a long view on EU MDR now and begin their digital transformation journey to support EU MDR and beyond.

Is your organization ready to achieve sustainable, positive disruption? Contact us today.