Category Archives: eBook

27Oct/20

eBook: Are You on the Right Side of the Digital Divide?

An Axendia Voice of the Customer eBook, Presented by Propel

By: Sandra K. Rodriguez, Market Analyst

Historically, Life-Science companies have implemented on-premise electronic quality management systems (QMS) to support regulatory requirements and to replace paper-based processes. Likewise, product lifecycle management (PLM) processes were often paper-based or in stand-alone systems disconnected from QMS, field service management and customer relationship management (CRM). With the advent of the cloud, organizations began leveraging the ability to integrate and access product, quality and customer information from anywhere, on any device, at any time in a secure and controlled manner.  

In this Voice of the Customer eBook, presented by Propel, we address how cloud-based digital solutions are enabling the unification of processes and data that once resided in outdated, disparate and disconnected legacy systems.  By taking a common platform approach, Life-Science companies are transforming and simplifying business processes in the cloud, driving organizational efficiencies in a compliant and cost-effective manner, and delivering greater customer satisfaction through it all.  

In this eBook, executives from Advanced Sterilization Products (ASP) and Cantel discuss:

  • The Value of an Integrated Platform
  • Getting Cloud Comfortable in a Regulated Environment
  • Faster Time to Value
  • Streamlined Compliance with Global Regulatory Requirements
  • Unlocking the Value of a Platform
  • Why Data Integrity is Business Integrity
  • The Benefits of a Closed-Loop Platform
  • Pros, Cons and Lessons Learned

To determine if your organization is on the right side of the digital divide, request your copy below.

03Aug/20

Building the Life-Science Factory of the Future, Today

Register for the Webinar and Request the eBook

The demand for organizational visibility, control and collaboration to achieve resilience is a catalyst to modernization and digital transformation in the highly regulated Life-Science industry. With Medical device and diagnostic products are becoming increasingly complex; next generation products cannot be effectively manufactured in last generation factories using old processes! Manufacturing next generation devices requires a digital factory that supports closed loop manufacturing and workforce optimization across the product lifecycle.

Join Axendia’s Sandra K. Rodriguez, Market Analyst and Thomas Muth, Global Life Science Industry Director at Dassault Systèmes DELMIA on 02-SEP-2020 at 11AM Eastern to learn how Life-Science companies are realizing the art of the possible by modernizing manufacturing, reinventing their value networks and building the Factory of the Future, today.

In this webinar, we will discuss:
• The Factory of the Future – Fact, Not Fiction
• The Workforce of the Future
• How to Build Resilient Value Networks
• Digitally Transforming Manufacturing
• Digital Evidence and the Review of the Future
• Leveraging the Power of a Digital Twin

You are also welcome to request this Voice of the Customer eBook, presented by Dassault Systèmes.

Please note: Axendia content is restricted to qualified individuals employed by Life-Science, Academic and Government organizations. No further reproduction, distribution, copying or dissemination is allowed without prior written permission from Axendia. By requesting this content, you are consenting to be contacted by Axendia, Inc. and/or the Sponsor. If you do not want to submit your information, you should not register.

09Jun/20

eBook: Digital Transformation and Manufacturing Mondernization

Is The Gain Worth The Pain?

By: Sandra K. Rodriguez, Market Analyst

Pharmaceutical organizations are continuously seeking to implement mature manufacturing technologies to ensure the availability of products for their patients.  Unfortunately, once a facility has been approved for manufacturing by regulators, it is often frozen in time for decades.   This has been one of the unintended consequences of regulatory enforcement and has led to the slow uptake of modernization and digital transformation in Pharma.  

Pharmaceutical business models are changing, and supply chains have become tightly integrated supply networks.  In addition, regulatory agencies, although often seen as the industry’s biggest business disruptori, are actually encouraging innovation in manufacturing.  Life-Science companies are cloud curious and most are in the pilot phase of implementing emerging technologies such as Artificial Intelligence (AI), Machine Learning (ML), Augmented Reality (AR) and Virtual Reality (VR).   

Based on Axendia’s primary research and interviews with executives on the adoption of modernization and digital transformation in the Life-Science industry, we determined that digital transformation and modernizing manufacturing often do not go hand in hand.  In fact, through our discussions and interactions with industry executives for this report, we quickly determined that digital transformation and modernizing manufacturing are not synonymous and often take different paths.    

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27May/20

Transforming Quality Management with a Modern Cloud Solution

Webinar Available On-Demand

By: Sandra K. Rodriguez, Market Analyst

For decades, life sciences companies have implemented on-premises quality management systems (QMS) to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings rather than to create visibility, traceability and accountability throughout the product lifecycle. Today, companies are taking a different course and are adopting a cloud culture to modernize processes, improve supplier collaboration, and drive better quality and business outcomes.

I was recently joined by Joe Vigil, Director Quality Systems at Ultragenyx, and Mike Jovanis, VP Vault Quality at Veeva Systems, to discuss the achieved business benefits of a cloud-based quality solution on a webinar presented by Veeva Systems.

We discussed the internal and external factors that are contributing to the adoption of Cloud QMS and the benefits of an industry cloud platform including time to value and reduced validation efforts.   

With merger and acquisition activities a daily reality in the life sciences industry, companies are growing at rapid rates. “We started our journey to a cloud QMS about three years ago in 2017. At that time, we had about 350 employees and no commercial products. Today we’re over 750 employees and have two commercial products. So, we’ve grown quite a bit in a few years’ time, and we really were looking for a cloud solution that could grow with us,” said Vigil.

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24Feb/20

eBook: Adopting a Cloud Culture in Support of Quality and Business Outcomes

Executive Accounts of Cloud QMS Success

In the Life-Sciences industry, organizations have implemented on-premises quality management systems (QMS) to support regulatory requirements and replaced paper-based processes for decades. However, these systems were often implemented to mitigate regulatory findings rather than create visibility, traceability and accountability throughout the product lifecycle.

Based on Axendia’s primary research and interviews with executives on the adoption of Cloud QMS in the Life-Sciences, we determined that many companies – large and small – are taking a different course. They are adopting a cloud culture while modernizing processes in support of better quality and business outcomes.

In this voice of the customer eBook, presented by Veeva Systems we review:

  • Getting Comfortable with Cloud
  • Not All Clouds are Created Equal
  • Why Cloud? Why Now?
  • End-to-End QMS Capabilities
  • Pros, Cons and Pitfalls to Avoid

Culture change is imperative to the success of any organization transitioning to the cloud.