Category Archives: Regulatory

24Sep/19

What to Expect in FDA’s Draft Guidance on Computer Software Assurance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On August 22, 2019, I was invited by the IoPP – Puerto Rico Chapter to present key takeaways from FDA’s anticipated Draft Guidance on Computer Software Assurance for Manufacturing, Operations and Quality System Software.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  • The industry lags in implementation of automated systems and new technologies due to lack of clarity, outdated compliance approaches, and perceived regulatory burden.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.

05Sep/19

Can Digital Evidence Replace Clinical Evidence?

A Straight from the Source Webinar Available On-Demand

FDA is encouraging the use of “Digital Evidence” to inform clinical trial design, predict clinical outcomes, support demonstration of safety and effectiveness, identify relevant patient populations, and support regulatory submissions. 

Digital evidence from in silico clinical trials have been shown to produce similar results as human clinical trials and under certain circumstances may replace clinical evidence. 

Join FDA’s Tina M. Morrison and Axendia’s Daniel R. Matlis for a live webinar on 18 SEP 2019 at 11:00 AM ET. 

We will discuss FDA’s perspective on: 

  • Shifting from traditional evidence sources to digital evidence  
  • How to create virtual patients with digital evidence to replace clinical evidence  
  • Examples of digital evidence in Pharma and Medical Devices used at FDA to initiate and augment clinical studies 
  • Creating an in silico clinical trial playbook
  • Why data in PDF’s are not sufficient 

Meet Your Trusted Sources

Tina and Dan for CC

Register to view this webinar on-demand.

register

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.

25Jul/19

Medidata: The Missing Link in Dassault Systèmes Powerful Portfolio to Support the Life-Science Industry

Dassault Systèmes Analyst Conference Brief 2019

By: Sandra K. Rodriguez, Market Analyst

The news out of this years’ Dassault Systèmes Analyst Conference was huge: a $5.8 Billion merger offer with clinical data giant, Medidata.  We received the news while traveling from our hotel to the Dassault Systèmes headquarters, nestled in Vélizy-Villacoublay, France.  Aside from the size of the deal – the largest in the history of Dassault Systèmes – Medidata was the missing link in its powerful portfolio to support the Life-Science industry.

Bernard Charlès, CEO and vice-chairman of the board of directors at Dassault Systèmes, opened the two-day meeting with, “To do ‘smart’ anything, you need to know the environment.  The platform phenomenon is not an IT topic… it’s a new way for companies to work.”  Dassault Systèmes now has 250,000 customers, with 25 million users in 140 countries.  The 3DEXPERIENCE platform currently consists of 11 brands/applications that support the ability for people and businesses to develop, collaborate and build products and services in both the virtual and real worlds.

Dassault Systèmes considers itself a Scientific company, first and foremost.   The Industry Renaissance theme of this years’ conference was explained in simple terms by Morgan Zimmermann, CEO for NETVIBES-EXALEAD (the Dassault Systèmes solution for turning large amounts of information into intelligence).  “Think of Renaissance as the new book. The book changed how we distributed knowledge; Industry Renaissance for Dassault Systèmes is the usage of experience as a new way to distribute knowledge and know-how” explained Zimmermann.

The 3DEXPERIENCE Platform offers both people and businesses, virtual universes to imagine, develop and collaborate using innovative solutions.

Life is the New Work Bench

Mentioned earlier in this brief, Medidata was the missing link in the Dassault Systèmes solution platform to support end-to-end product development in the Life-Sciences.  “Pharmaceutical and Biotech companies require roughly ten to twelve years in the R&D phase to bring a drug or therapy to market” explained Claire Biot, Ph.D., VP of Life Sciences Industry at Dassault Systèmes.  Therefore, shifting that timeline left early on in the clinical trial phase of a product adds significant value to Life-Sciences companies.

Image Courtesy of Dassault Systèmes

Image Courtesy of Dassault Systèmes – Claire Bisot.

Clinical trials are necessary to prove the safety and efficacy of a drug on not only a patient population, but the medical condition itself.

Download and read the entire Briefing Note.

15Jul/19

More Than Skin Deep: Dassault Systèmes is Transforming the Patient Experience

Dassault Systèmes 3DExperience North America 2019 Forum Event Brief

By: Daniel R. Matlis, President

At this year’s 3DEXPERIENCE North America Forum, Dassault Systèmes continued to demonstrate its commitment to transforming the patient experience.

Under the leadership of Bernard Charlès, Vice Chairman, Chief Executive Officer, the company continues to substantially deliver on the promise: “to enable innovative patient experiences through a Holistic Patient-Centric strategy.”  (Read:  Dassault Targets Life-Sciences with Mind, Body and Soul)

According to Charlès there are several concurrent themes that are impacting the Life Science industry with Bioscience playing a major role.

  • Healthcare is expensive
  • Healthcare needs to be more inclusive
  • Life-Science product development needs to take advantage of technological changes

“Dassault Systèmes is investing massively in Life Sciences to transform the patient experience with a culture of sustainable innovation and the use of cutting edge technology,” added Charles. Continue reading