31May/16
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The Rubber Meets the Road with MES

By: Sandra K. Rodriguez, Research Associate

14th Werum PAS-X User Group Meeting 

It’s hard to image that attending a MES User Group Meeting would make you walk away with the impression that successful MES implementations are not simply about the best technology, but that was the case at Werum’s User Group Meeting (UGM) in Morrisville, NJ on May 12-13, 2016.  Rudiger Schlierenkampf, CEO, Werum IT Solution and Benjamin Pieritz, Senior Vice President Operations, Werum IT Solutions, kicked off the meeting by providing a company update and announcing 15 years of success throughout North America.

Clients and prospects gathered to share best practices, success stories and the challenge of automating a historically paper-driven process.  Overall, the hot button topics were business process harmonization and cultural change management.  While great technology is required, it is not sufficient to ensure a favorable outcome.

TECHNOLOGY IS NOT SUFFICIENT TO ENSURE MES SUCCESS

Software companies are beginning to understand that their products are only as good as the requirements they are built to meet.  Input from the user community is critical not only to maintain market share, but to ensure the product is future proof.  As life science companies move from point solutions to platforms and streamline their IT operations and consolidate enterprise systems, Werum is working on ensuring the adoptability of their solutions to this new IT landscape. Continue reading

27May/16
future-technology-3d-printer

3D Printing is the New Supply Chain Disruptor

Navy Officials: 3D Printing To Impact Future Fleet with ‘On Demand’ Manufacturing Capability

By John Joyce, NSWC Dahlgren Division Corporate Communications

DAHLGREN, Va. – Is it possible to produce parts and equipment from scratch for Sailors – aboard ships and on demand?

Can the Navy rush deliver parts and high-tech gear such as customized unmanned systems, avionics components, and improvised explosive device detectors to its warfighters?

“Yes we can,” say Navy officials and when Additive Manufacturing – also known as 3D Printing – fully hits the Fleet, Sailors could receive their orders within a substantially reduced time frame.

Remarkably, Sailors and Marines are already inventing new products, expanding the realm of possibilities made real by 3D printing while saving time, resources, and money. Continue reading

26May/16
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QMS comes from the Cloud

Veeva Expands Native Cloud Offering for Quality Management with Vault QMS

Life Science companies are increasingly operating within global and outsourced models.  While the operational paradigm has changed, quality systems and technology infrastructures have not kept pace.  As a result, managing quality and compliance activities in an increasingly fragmented ecosystem is a difficult and labor intensive process.Too-Much-Tech

This is not for a lack of technology. Axendia’s research consistently shows that most companies use a multitude of stand-alone systems. These were generally implemented by functional areas and sites to address specific regulatory compliance needs. Consequently, most companies have redundant systems that are generally accessible by a limited number of people and only within a company’s four walls.This approach is very inefficient and makes reporting a single version of the truth across the global and outsourced ecosystem difficult if not impossible since it:

  • Creates data islands that hinder visibility across a global organization
  • Makes solving companywide problems across data islands extremely difficult
  • Is tedious and costly to coalesce data into meaningful information

As a result, it is difficult to connect the dots to make “intelligent “decisions.

A Solution from the Cloud?

To support a single source of truth, Life Science organizations need platforms that provide visibility, control, collaboration and data integrity across the ecosystem.

Veeva recently briefed Axendia on Vault Quality, a cloud native suite of products that combines Vault QualityDocs with the new Vault QMS. Vault Quality provides a seamless QMS and quality content management solution, enabling collaboration across internal and external constituents throughout the ecosystemVeeva-Quality.

Veeva built Vault QMS on top of its widely used Vault platform.  This enabled its team to leverage infrastructure and functionality – from Veeva’s suite of enterprise applications – releasing the quality solution in record time (6 months sooner than originally expected).

To empower Life Sciences companies and streamline their business processes across an increasingly broad ecosystem of internal and external stakeholders, today’s platform must support collaboration and the ability to provide the right people access to the right information every time, from anywhere.

Vault Quality supports a single source of truth by facilitating:

  • The ability to model and support processes that span internal and external partners.
  • Direct access to a Life Sciences company’s systems and applications in real time for authorized external partners.
  • Easy sharing and exchanging of content to support collaboration and more controlled processes
  • Real-time access to accurate information to support Visibility, Control and Data Integrity
  • Collection and analysis of data needed to support quality and compliance requirements
  • A single source of truth for information to support a regulatory audit across an entire supply chain

New Business Models Call for New Approaches

Global_Computer_Network_blue_cTo support a single source of truth across a global and outsourced ecosystem, Life Sciences organizations are shifting their focus from internally facing point solutions to platforms designed to give appropriate people access to the right information, every time, from anywhere.  This level of transparency offers a single source of truth for all parties — leading to improved control and collaboration, as well as simplifying complex and error prone processes that involve quality data and documents.

Veeva’s Vault Quality cloud native solution supports the ability to achieve a single source of truth to reduce complexity and increase business agility across today’s global and outsourced ecosystem.

20May/16
Living-Heart-App

Want to Study the Living Heart? There’s an App for That!

By Daniel R. Matlis, President

The Holy Grail of Life-Science and Healthcare is the development of a virtual human model.Living-heart-project

The quest towards unlocking the virtual human model made a giant leap when Dassault Systèmes announced that it had signed a five-year collaborative research agreement with the FDA to target the development of testing paradigms for the insertion, placement and performance of pacemaker leads and other cardiovascular devices used to treat heart disease.

Living-Heart-AppTo make the technology more personal, mobile and available, Dassault Systemes released the “The Living Heart Experience” app in the iTunes store.  The App provides viewers with the opportunity to explore and interact with the Living Heart Human Model in 3D.

This technology provides a glimpse into the future of medicine where cardiovascular experts can explore treatment options, educate patients, and study the efficacy of new medical devices and predict reliability under real-world conditions.

These advancements in modeling and simulation technologies are allowing medical researchers to create computational models of complex human systems such as the heart and brain. Using patient data and simulation-based predictive computational techniques, researchers can simulate, predict, and understand the impact of specific treatments on a patient without the need for additional invasive diagnostic procedures.

To learn more about the Living Heart Project read:

05Apr/16
2015-FDA-MDQS-Data-Final

Infographic: FDA Medical Device Quality System Data

Inspections, FDA Form 483 Observations and Warning Letter Citations

In support of the FDA’s Transparency and Case for Quality Initiatives, the Center for Devices and Radiological Health (CDRH) provides annual data on inspections, inspectional observations, and Warning Letter (WL) citations issued.

Production and Process Controls, followed by Corrective and Preventive Actions continue to be the most frequently cited QS subsystems.

The infographic below breaks down foreign v. domestic inspection data for Calendar Year (CY) 2015.  Continue reading