Tag Archives: Sparta Systems

19Mar/19
Sparta CSA eBook Cover

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 Infographics Header copy

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.

11Jun/18
TWD platform diagram - Sparta Systems (002)

Sparta Systems Launches TrackWise Digital SaaS Offering

Life Science Companies are Seeing the Value of Moving to a Cloud-based QMS that is Scalable in Support of a Much Needed Digital Transformation in the Industry

By: Sandra K. Rodriguez, Market Analyst

The Sparta Systems management team recently briefed Axendia on the newly unveiled TrackWise Digital cloud quality management system software platform.  The company, founded in 1994, has undergone several key changes as of late such as a recent acquisition by private equity group New Mountain Capital, and new executive leadership in Dana Jones, CEO  and Vinit Doshi, COO who both joined the company earlier this year.

In addition to TrackWise Digital, Sparta still offers the solution it is perhaps best known for – TrackWise, an enterprise QMS platform.  Although it is a traditional on-prem application, Sparta offers extended cloud capabilities such as quality event intake and supplier collaboration by utilizing a hybrid architecture and seamless user experience.

“Sparta Systems has been a leader in quality management software for the pharmaceutical, medical device, consumer product, and discrete manufacturing industries for over decades. In 2016, Sparta acquired cloud QMS platform 123Compliance, and following a two-year period of heavy investment, rebranded the platform as TrackWise Digital to signal that in our view, it is now equal to our legacy TrackWise platform,” said Brandon Henning, Director of Product Management for TrackWise Digital. Continue reading