Category Archives: Regulatory

04Oct/21

Digital Transformation: The Business Imperative for Life-Sciences

By Daniel R. Matlis, President

“Necessity is the mother of invention,” says the ancient proverb.  In my opinion, the corollary is: “disruption is the matriarch of transformation,” especially for the Life-Sciences industries.

The COVID-19 epidemic has been the biggest global disruption in our generation. It represents a watershed moment for transformation throughout our industry.

Disruption is the new normal. This new paradigm is forcing Life-Science companies to re-imagine the way they operate; transforming and accelerating product development, regulatory review, manufacturing, and distribution cycles aimed at improving patient outcomes.

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01Sep/21

FDA Reports on The State of Pharmaceutical Quality

Remote Evaluations, Grading Industry on a Curve and Using AI to Predict Site Inspection Scores

By: Axendia Staff

The FDA issued its latest report on the State of Pharmaceutical Quality.  In the report, the Agency describes Pharmaceutical Quality as the ability of the pharmaceutical manufacturing industry to deliver quality drug products to U.S. patients and consumers. In addition, FDA defines quality drug products as those that are safe and effective and free of contamination and defects.  It is worth noting the absence of the word “compliant” in these definitions.

Hidden among Hand Sanitizer recall data were a number of significant developments on FDA’s regulatory approach.

This Brief represents Axendia’s analysis and insights on FDA’s Report on the State of Pharmaceutical Quality.

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30Jul/21

Medical Device Cybersecurity Throughout the Product Life Cycle

By: Thomas Maeder, Industry Analyst, Axendia

“The United States faces persistent and increasingly sophisticated malicious cyber campaigns that threaten the public sector, the private sector, and ultimately the American people’s security and privacy,” begins the May 2021 presidential executive order on improving the nation’s cybersecurity.  Recent crippling cyberattacks on the Colonial pipeline and JBS Foods, and the SolarWinds and Microsoft Exchange hacks, among others, have painfully highlighted the fragility of the information and operational technologies on which the modern world so heavily relies. 

Cybersecurity in Healthcare

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23Jun/21

Quantum Computing Opens New Opportunities for Life-Sciences in Europe

IBM and Fraunhofer Unveil Fastest Quantum Computer in Europe – Event Brief

By: Eric M. Luyer, Industry Research Analyst Axendia Inc.

Axendia Inc. was present on 15-JUN-2021 at the official inauguration of the first IBM Quantum Computer in Europe by IBM and the Fraunhofer-Gesellschaft. The setting was a compact virtual live event with highly distinguished guest speakers: Dr. Angela Merkel – German Chancellor, Dr. Arvind Krishna – CEO and Chairman IBM, Prof. Dr. Reimund Neugebauer – President of the Fraunhofer – Gesellschaft e.V. as well as various representatives of large industries such as Trumpf, Bosch, BASF, BMW and others.

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02Jun/21

Leading Companies Modernize Quality Management in the Cloud

Veeva Briefing Note

By: Sandra K. Rodriguez, Sr. Industry Analyst

Axendia was recently briefed by Mike Jovanis, vice president of Vault Quality and Kent Malmros, senior director of Vault Training at Veeva Systems.  Veeva Systems (www.veeva.com) is a cloud computing company focused on the pharmaceutical and life sciences industry.

Veeva Vault Quality customers continue to increase in numbers and now include 14 of the top 20 largest pharmaceutical companies. Leading companies around the world are adopting a cloud culture to lower the cost of implementation and ownership, enable collaboration with external partners, and simplify business processes.  To date, more than 175 biopharma, contract manufacturers, generics, and medtech companies, have adopted Vault QMS to streamline and automate quality processes. “As a trusted partner, Veeva has been collaborating closely with life sciences companies globally on their digital quality initiatives,” said Mike Jovanis, vice president, Veeva Vault Quality. “We are committed to customer success and will continue to deliver customer-focused innovation across product development and manufacturing.”

Vault QMS is part of the Veeva Vault Quality Suite, including Vault Product Surveillance, Vault QualityDocs, Vault Station Manager, and Vault Training to automate and harmonize quality processes globally.

Veeva’s continuous innovation is helping customers proactively manage quality and increase agility. Over the last year, new features for Vault QMS include:

  • Seamless connection between Vault QMS and Veeva Vault Registrations to reduce cycle time and increase transparency within post-market change control
  • Quality Risk Management (QRM) advancements, including FMEA methodology to support proactive identification and mitigation of risks
  • Fully automated process for external auditees such as CMOs and suppliers to respond to audit findings directly within the system
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