Category Archives: Regulatory

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.

 

 

12Mar/19
Siemens CSA EBook Cover

eBook: CSA – A Streamlined Approach to Validation

Computer System Assurance in Support of Manufacturing 4.0

By: Daniel R. Matlis, President

Computer System Validation (CSA) is a streamlined approach to validation that supports Manufacturing 4.0 in the Life-Sciences.   Medical Device Executives believe this new approach will result in a 30% to 50% reduction in time and cost, and will increase and accelerate improvements and innovation.

This eBook includes success stories and first-hand examples by:

Axendia_Validation_P10-copyrightedFrancisco (Cisco) Vicenty, Program Manager – CfQ, US FDA

Jason Spiegler, Sr. Director, Industry Portfolio Development, Siemens PLM

Damien McPhillips, Sr. Quality Manager – Global Software and Digital Health, Boston Scientific

Ray Murphy, Principal Software Quality Engineer, Boston Scientific

April Francis, Director Global IT Quality and Compliance, Medtronic

Frank Melendandri, Sr., Manager, Quality Assurance, Zoll Lifevest

 

This paradigm shift has had an enormous impact on the industry.  Backed by the FDA, a new era of computer system validation is here. According to Cisco Vicenty, CfQ Program Manager at FDA: “All the recommendations that the Non-Product CSV Guidance is highlighting, is within scope of the FDA’s QSRs and is compliant.”
Continue reading

05Mar/19
Radar Square for LSP-Zoom only-extra small

Disruption is on the Radar! You Must Plot a Course for Success.

Webinar Available On-Demand

Disruption is on the radar! Life-Science executives must plot a course for success.  That was the theme of our “Straight from the Source” webinar featuring Axendia’s President, Daniel R. Matlis and Sandra K. Rodriguez, Market Analyst, on February 20th.

Since 2005, Industry stakeholders and regulators have relied on Axendia for trusted advice on Business, Regulatory and Technology issues and trends.  Due to our track-record of accurately predicting Life-Science trends, our clients often ask us to forecast what’s on the horizon.

To answer this question, we developed a Life Science radar to communicate our focus areas in the markets we service, as well as share when we predict these trends will become mainstream. Continue reading

20Feb/19
Siemens CSA EBook Cover

FDA Shares a New Approach to CSV

A Straight from the Source Webinar

The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

Join us for a live webinar on March 7th at 1pm Eastern.  We will discuss FDA’s perspective on Computer Software Assurance (CSA) including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization.
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

Meet Your Trusted Sources

Dan and Cisco 2019 Webinar

 

 

 

 

 

 

Please Note:  This webinar is limited to the first 100 registrants.

Can’t make the live session? No problem!

Register for the live session and receive access to the on-demand recording!

register

12Feb/19
Radar Square for LSP-Zoom only-extra small

A Disruptive Storm Is On The Horizon

A Straight From the Source Webinar

A disruptive storm is on the Horizon and Life-Science Executives MUST plot a course to success.

Join us for a live webinar on February 20th at 11am Eastern as we discuss our insight and advise on Business, Regulatory and Technology Disruptors that are quickly approaching, including:

  • Artificial Intelligence/Machine Learning
  • Computer System Assurance
  • Digital Health
  • Digital Transformation
  • EU MDR
  • Globalization – Healthcare Markets
  • Industry 4.0/Manufacturing 4.0
  • Precision Medicine
  • The Internet of Medical Things (IoMT)

Meet Your Trusted Sources:

DRM-SKR-FEB-2019

Please Note:  This webinar is limited to the first 100 registrants.

register