Tag Archives: CSA

24Sep/19
Validation - original (1)

What to Expect in FDA’s Draft Guidance on Computer Software Assurance

Recap of the Institute of Packaging Professionals (IoPP) – Puerto Rico Chapter Meeting

On August 22, 2019, I was invited by the IoPP – Puerto Rico Chapter to present key takeaways from FDA’s anticipated Draft Guidance on Computer Software Assurance for Manufacturing, Operations and Quality System Software.  Thirty-two attendees from fifteen companies attended the quarterly meeting at the C3Tec campus in Caguas, Puerto Rico.

Sandra IoPP PR 2Background:  Unfortunately, when the Medical Devices Current Good Manufacturing Practice (CGMP) Final Rule, Quality System Regulation, became effective on June 1, 1997, they had an “unintended consequence”:  Validating Computer Systems to death!

According to FDA’s Francisco (Cisco) Vicenty, Program Manager, Case for Quality, FDA CDRH, the Life-Science industry’s high focus on meeting regulatory requirements versus adopting best quality practices has the potential to increase risks to patients.  This compliance-centric approach has resulted in quality issues and has hampered innovation in manufacturing and product development practices.  Additionally, this single-mindedness has led to low rates of investment in automation and digital technologies.

To streamline and improve non-product computer system validation, industry launched a shared effort with FDA to identify causes of misperceptions, to clarify, and to promote the best practices.

Their analysis of the issue shows that:

  • The industry lags in implementation of automated systems and new technologies due to lack of clarity, outdated compliance approaches, and perceived regulatory burden.
  • Some companies struggle to understand the root cause of issues in order to improve product quality.

Their vision to achieve a new mind-set:

  • Drive a paradigm shift in applying value-driven and patient-focused approaches to streamline non-product software CSV.
  • Use critical thinking and risk-based, agile approaches to streamline assurance activities and evidence capture.

Their plan to meet their objectives:

  • Develop streamlined practice recommendations and pilots.
  • Modifications to the 820.70(i) and 820.50 regulatory language.
  • Guidance development centered on this software category.

Roque Redondo, VP Business Development at Mirus offered his perspective during the Q&A session by commenting, “It’s very important to understand if companies that provide software to our industry can demonstrate that they really have strong QA Systems in such a way that we can all rely on their software development programs.  I strongly recommend doing a survey of these companies to find out if they will be completely open to QA Audits from their clients to fully demonstrate that their QA Systems are in place and trustful.  In addition, it will be good to investigate if the excessive amount of CSV efforts done in the industry are due to the current guidelines or to the interpretation of the guidelines.”

It was a pleasure to share this information locally to my industry peers.

To hear the FDA’s perspective on the New Approach to Computer Software Assurance in our Straight from the Source webinar series, access it on-demand.

28May/19
Dan and Cisco 2019 Webinar

FDA Answers Your Questions on the New Approach to CSV

Q&A from an Axendia Straight from the Source (SftS) Webinar

By: Francisco Vicenty, FDA, CDRH and Daniel R. Matlis, Axendia, President

In our recent webinar, we discussed FDA’s perspective on Computer Software Assurance (CSA).  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.

In this “Straight from the Source” webinar, we discussed FDA’s perspective on 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

There were many more questions submitted than could be answered in the time allotted.

Register and receive your internal-use copy of the full Q&A.

 

 

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

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