Category Archives: Regulatory

04Feb/20

Data Governance: the Foundation for Data Integrity and Digital Transformation

An Axendia Straight from the Source Webinar

Life-Science companies are obsessed with collecting data, retaining and hoarding it to meet statutory and regulatory requirements.

Unfortunately, most companies do not manage these data and as a result are unable to harness it to improve quality, compliance or process efficiency.

A formal data governance program supports the definition, production, and usage of data across its lifecycle to manage risk and improve the quality of data assets.

Join Joseph Ricci from Absolute Integration Inc., and Axendia’s Daniel R. Matlis for a live webinar on 04-March-2020 at 11:00 AM ET to learn how Data Governance is the foundation for data integrity and digital transformation.

We will discuss:

• The business, regulatory and technology benefits of formalizing Data Governance
• Building and formalizing a meaningful and non-invasive program
• Data Governance as a process, not a project
• How to use Data Governance as the foundation for data integrity and digital transformation.

Meet Your Presenters

Can’t make this time? Register and you will be able to watch the On-Demand recording after the event.

10Jan/20

Webinar: Real-Time Operations Intelligence for Life-Sciences

Reduce Validation Efforts Up to 70% 

In this webinar presented jointly by Axendia, Bigfinite, and Honeywell, we will discuss how companies are increasing quality and efficiency by consolidating disparate manufacturing data with new batch visualization, advanced analytics, artificial intelligence and IoT. Learn how new capabilities can offer:

  • Improved process efficiency and yield
  • Predictive quality insights
  • Integrated, real-time visualization
  • Effective troubleshooting
  • Workflow efficiency
  • Reduced validation effort

On February 5, 2020 at 10AM Eastern, we will also discuss how to stay GxP-compliant while reducing documentation and validation efforts by up to 70%, bringing product to market faster.

Meet Your Presenters

Honeywell-Webinar-Speakers

Dan Matlis, President of Axendia, will moderate as industry thought leaders Pep Gubau and Matthias Maaz, illustrate strategies to achieve intuitive process and operational intelligence, improving manufacturing operations in a GxP compliant manner with end-to-end data integrity.

register

06Dec/19

2020 Life Science Radar – Webinar Registration is Open!

An Axendia Straight from the Source Webinar

Disruption is on the radar! Life-Science executives must plot a course for success. That was the theme of our “Straight from the Source” 2019 Life-Science Radar webinar featuring Axendia’s Analysts.

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 2019 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.

Join us on January 29th at 11am Eastern. Axendia’s Analysts will discuss the updated 2020 Life-Science radar.

Many disruptors are closely connected and Life-Science organizations must take a holistic view when it comes to business, regulatory and technology trends in order to plot a course to success.

Can’t make this time? Register and you will be able to watch the On-Demand recording after the event.

register

05Nov/19

Transforming Quality, a Top Priority for Customers at Veeva Summit 2019

Veeva Summit 2019 Event Brief

By: Daniel R. Matlis, President

Veeva has become a strategic technology partner to more than 775 customers across the globe, ranging from the world’s largest pharmaceutical companies to emerging biotechs.

Veeva-Summit-Check-In

I had the opportunity to cover the 2019 Veeva R&D Summit in Philadelphia, PA in September.  The event brought together more than 1,700 life science professionals and experts to share the latest market trends in the industry, experience innovative technology, and share best practices. The annual event has experienced 25% attendance growth compared to 2018.

This brief focuses on my first-hand interactions with leading industry executives leveraging Veeva’s quality offerings to modernize quality management in the cloud.

The following executives shared how they are leveraging modern cloud-based solutions to transform quality management:

  • James Choi, VP and CIO at Samsung BioLogics, shares his vision for modernizing manufacturing quality.
  • Chris Lamont, Director, Global QMS Programs at Bristol-Myers Squibb presents the company’s journey to achieve enterprise quality with Vault QMS.
  • Jennifer Trundle, Associate Director, Quality Management Systems at Gilead discusses the successful expansion of Vault QualityDocs across the global enterprise.

Continue reading

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.