Category Archives: Regulatory

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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14May/21

FDA Guidance on ICH Q12 Will Accelerate BioPharma PLM Adoption

As Bio-Pharmaceutical companies look for opportunities to accelerate innovation cycles, the management of products across the complete lifecycle to support continuous improvement is a strategic imperative.  To fast-track innovation, companies need to be open to new ideas and have awareness of new and emerging systems and technologies. 

This week, FDA issued guidance supporting the use of ICH Q12 to encourage the use of Product Lifecycle Management across the Pharmaceutical.

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13May/21

Driving Digital Transformation in a Connected Eco-System

Life-Science companies of all sizes are digitally transforming to improve quality, from raw material to patient, while achieving resilience, effectiveness & efficiency.

Hear from Edward Armstrong, Director QA at Mustang Bio, Beth Hayes, VP, BioPharma Strategy at Salesforce, Prashanth Rajendran, CEO at ComplianceQuest and Daniel R. Matlis, President at Axendia in this panel discussion

Take a sneak peak of our candid discussion in this video clip:

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14Apr/21

Q: Who is the Best Technology Vendor? A: NONE!

An open Letter to the Life-Sciences Industry on Analyst Forced Vendor Rankings

By: Daniel R. Matlis

As a Life-Science Industry Analyst, I am often asked by executives to recommend the best technology vendor.

My standard answer:  None, there is no such thing as a “best vendor.”   

Just like an automotive industry analyst could not recommend the “best car” for you until they know your budget, unique requirements, and primary use; a Life Science industry analyst must understand your company’s intended use, business, regulatory and technology requirements, as well as organizational culture before recommending a system.

Yet for decades, Life-Science industry executives have relied on forced rankings from analyst firms to identify the top five vendors to invite for an RFP.  This is especially true when evaluating the alphabet soup of system acronyms (AI/ML, APS, CTMS, CM&S, EAM, EDC, ERP, LIMS, MES, PLM, RIM, SCM, etc., etc., etc.)

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