26Mar/19
MedTech-Must-Embrace-Industry-4.0-Home (002)

New Whitepaper Series – Why MedTech Must Embrace Industry 4.0

Medical Device Companies Must Embrace Modern Manufacturing Execution System (MES) Strategies to Future-Proof Their Business

By: Sandra K. Rodriguez, Market Analyst

FDA’s upcoming guidance on Computer Software Assurance (CSA) paves the way for Digital transformation and Industry 4.0 in MedTech. The Agency recognizes that systems like MES provide manufacturers advantages for reducing or eliminating errors, increasing business value, optimizing resources, and reducing patient risk.

Need a roadmap to enable Industry 4.0 in MedTech?  Read this whitepaper series to discover:

  • How to use MES as the backbone to enable Industry 4.0
  • Why modern MES support the transition from compliance to excellence
  • How to enable a step change for your business and patient outcomes
  • Ways to utilize Industry 4.0 across your manufacturing network

Download the series here and start your digital manufacturing transformation.

This white paper series was sponsored by Critical Manufacturing.

22Mar/19
modernizing pharma manuf image

FDA Shares Quality Considerations for Continuous Manufacturing

A Straight from the Source Webinar

 FDA is committed to supporting and enabling pharmaceutical innovation and modernization. The Agency recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients.

Join FDA’s Thomas O’Connor, Ph.D. and Axendia’s Daniel R. Matlis for a live webinar.

Date and Time:  April 17th at 11:00 AM ET. 

We will discuss FDA’s perspective on pharmaceutical innovation and modernization including:

  • FDA’s draft guidance on Quality Considerations for Continuous Manufacturing
  • How continuous manufacturing can improve pharmaceutical manufacturing
  • Support of enhanced development approaches such as quality by design (QbD), process analytical technology (PAT) and models
  • Insights from dialogue with sponsors through the Emerging Technology Program, externally funded and internal research
  • Experiences from review and approval of five drug applications utilizing continuous manufacturing to date

Meet Your Trusted Sources

dan and thomas SFTS image

Scheduling Conflict? Register and receive a link to view the on-demand recording after the event.

Participation is Limited!

register

21Mar/19
Jama-logo-primary-gradient-lightbg-w_35

Unstructured Tools Are Not A Good Fit For A Structured Process

Jama Software Brief

By: Sandra K. Rodriguez, Market Analyst

The Jama Software executive team recently briefed Axendia on its product development platform that is comprised of its flagship product – Jama Connect – and newly developed Jama Analyze.  Headquartered in Portland, Oregon, the company aims to help medical device companies modernize, digitize and transform an increasingly complex product development process.

Jama Connect allows companies to focus on quality from the standpoint of requirements, risk management and testing and brings it all together in a modern, collaborative and centralized way.  “Customers are coming to us to really drive innovation and quality in an accelerated time frame as they face competitive pressures,” said Joel Hutchinson, Product Manager at Jama Software.

Companies ranging from Merck to Boston-Scientific are managing requirements, risk, test and project volatility through the use of Jama Connect.

Please register to receive your complimentary copy of this Brief.

 

19Mar/19
Sparta CSA eBook Cover

eBook: Goodbye Computer System Validation…

Hello Computer System Assurance (CSA)!

By: Daniel R. Matlis, President and Ellyn McMullin, Research Associate

FDA supports and encourages the use of automation systems and digital technologies throughout the product lifecycle to improve patient outcomes and reduce the risk to patients. It is a common misconception that extensive testing and documentation is required to demonstrate the validation of computer software used in automation.

The FDA, recognizing industries CSV challenges, has announced new guidance on “Computer Software Assurance for Manufacturing, Operations and Quality System Software.” This guidance is on the Agency’s “A-list” and is planned for release in FY 2019.

The content is this eBook represents Axendia’s analysis and opinions on “Computer Software Assurance for Manufacturing, Operations, and Quality System Software” based on the following trusted sources:

  • Axendia’s interaction with FDA representatives on this topic
  • Content and material sourced from FDA
  • First-hand experience from Axendia’s clients on the implementation of CSA

Register to receive this eBook, sponsored by Sparta Systems, and learn:

  • Why Critical Thinking is the Foundation of CSA
  • How to Implement a Risk-Based Approach to CSA
  • The Objectives of CSA
  • What the CSA Landscape Looks Like
  • Acceptable Levels of Assurance

Webinar also now available on-demand:  Understanding the FDA’s New Approach to Computer System Validation.

 

 

14Mar/19
rootstock

Rootstock Offers Cloud Native ERP Built for the Salesforce Platform

Briefing Note

By: Daniel R. Matlis, President

Axendia was recently briefed by Rootstock’s executive team.  The team has deep experience in the Enterprise Resource Planning (ERP) market dating to the 1970’s

Rootstock offers a cloud native ERP solution for companies that manufacture, distribute, service and/or repair goods built on the Salesforce (SFDC) platform. The company serves emerging growth, midsized and enterprise companies including those who are replacing legacy and entry level ERP systems.

“We built our ERP product right alongside Salesforce CRM to manage the entire customer relationship on one platform,” said Tom Brennan, Chief Marketing Officer at Rootstock.    “In the diagram below you can see the Salesforce Sales Cloud on the left managing the front end to acquire customers. Then to the right you see the Salesforce Service Cloud in place to run the customer call center and field service.  We manage everything in between.  We provide the ordering, sourcing, production, inventory, invoicing and accounting functions in between the customer acquisition and customer service functions.  We, combined with Salesforce, have an end-to-end process built around the customer life cycle. Life Science companies get more efficient processes, but also a 360° view of the customers and their entire business,” he explained.

Register to receive our latest Briefing Note and learn how Rootstock ERP provides features and capabilities that ease the burden and cost of regulatory compliance while improving efficiency and connectivity for its Life-Science customers.