20Feb/19
CSA IMAGE FOR CC

FDA Shares a New Approach to CSV

An Straight from the Source Webinar

The FDA has recognized that existing perceptions and approaches to computer system validation (CSV) are a significant barrier to improving digital capability, product quality, and patient safety and is working swiftly to reverse this trend.

Join us for a live webinar on March 7th at 1pm Eastern.  We will discuss FDA’s perspective on Computer Software Assurance (CSA) including:

  • FDA’s upcoming Guidance on CSA for Manufacturing, Operations, and Quality System Software
  • Applying critical thinking and risk-based principles to support technology modernization.
  • Identifying Acceptable Records of Assurance
  • Leveraging CSA to accelerate digital transformation

Meet Your Trusted Sources

Dan and Cisco 2019 Webinar

 

 

 

 

 

 

Please Note:  This webinar is limited to the first 100 registrants.

Can’t make the live session? No problem!

Register for the live session and receive access to the on-demand recording!

register

14Feb/19
Science and DNA

eBook: Data Integrity – The Foundation of Good Science

Good Data Alone is Not Good Enough

By: Sandra K. Rodriguez, Market Analyst and Ellyn McMullin, Research Associate

Healthcare is shifting to a Value Based model focused on improving the quality of patient outcomes, enhancing patient-centered care and adopting initiatives that control costs.  The transition to Value Based Healthcare hinges on the availability of unbiased quality and outcomes data. Furthermore, the integrity of these decisions depends upon the accurate and objective analysis of these data to support patient care decisions.

ALCOA - Axendia 2019 - originalFDA has defined data integrity as the completeness, consistency and accuracy of data.  Complete, consistent and accurate data have the following attributes using the acronym ALCOA:

Attributable

Legible

Contemporaneously recorded

Original or a true copy

Accurate

Sound data is the foundation to good decisions and good science.  In the Life-Science industry, patient outcomes, product quality, safety and efficacy all rely upon vast amounts of data that is generated throughout the product lifecycle.  This means that patients and the equity and reputations of brand owners have the potential to suffer greatly without a strong data integrity foundation.

Register to receive our eBook and discover:

  • What is Data Integrity?
  • Why Data By Itself is Not Enough
  • How Data Integrity Enables Good Decision Making
  • Who is Responsible for Data Integrity
  • Quality Metrics Reporting Requirements
  • Why You Should Focus on Data Integrity
  • The Components of an Optimal Solution

Is your company doing good science?  Without data integrity, the results of that science can be in question.

12Feb/19
Radar Square for LSP-Zoom only-extra small

A Disruptive Storm Is On The Horizon

A Straight From the Source Webinar

A disruptive storm is on the Horizon and Life-Science Executives MUST plot a course to success.

Join us for a live webinar on February 20th at 11am Eastern as we discuss our insight and advise on Business, Regulatory and Technology Disruptors that are quickly approaching, including:

  • Artificial Intelligence/Machine Learning
  • Computer System Assurance
  • Digital Health
  • Digital Transformation
  • EU MDR
  • Globalization – Healthcare Markets
  • Industry 4.0/Manufacturing 4.0
  • Precision Medicine
  • The Internet of Medical Things (IoMT)

Meet Your Trusted Sources:

DRM-SKR-FEB-2019

Please Note:  This webinar is limited to the first 100 registrants.

register

 

 

17Jan/19
EU MDR Infographics Header copy

EU MDR Strategies: How To Achieve Market Advantage While Streamlining Regulatory Compliance

An On-Demand Webinar Presented in Conjunction with Kalypso

The European medical device industry is undergoing a transformation as the new European Medical Device Regulation is set to replace Medical Device Directives (93/42/EEC) and Active Implantable Medical Device Directive (90/385/EEC) by 2020.

The European Union Medical Device Regulation (EU MDR), which was published in the Official Journal of the European Union on May 5th, 2017, is aimed at restoring confidence in the European regulatory system after widespread safety issues and corrupt Notified Body engagements. These regulations are directed to increase post-market surveillance, expand the use of Unique Device Identifiers and provide better oversight of Notified Bodies.

Access the webinar recording and listen in as we discuss:

  • EU MDR Background
  • Industry Challenges
  • Our Infographic on EU MDR
  • Why Digital Transformation is Necessary for EU MDR and Beyond
  • Role-Based Apps and PLI Algorithms
  • A New Approach to EU MDR Compliance

David Wolf, Senior Manager at Kalypso pointed out, “IoT Apps are allowing companies to mashup data from multiple systems in a more agile and less expensive manner then traditional integration methodologies.  These role-based apps allow companies to break down the barriers between Product Development, Document Control, Quality, Regulatory and Service departments.”

From a business perspective, resource constraints, adequate knowledge of the regulation and older products are major concerns for manufacturers.  On the technology side, disparate and siloed or paper-based systems continue to plague medical device manufacturers since EU MDR requires a data-intensive total product lifecycle management.

Wolf concluded with, “To stay competitive and keep up with the evolving regulatory changes, companies will need to pioneer cutting edge software solutions while consolidating source systems.  By expediting new capabilities and having greater maturity in PLM with cleaner, more consolidated product data, the best in class companies can capitalize on key role-based apps and advanced analytic use cases.  This helps medical device manufacturers become more flexible and responsive when responding to new regulations, with the additional benefit of creating a repeatable process that can be utilized the next time a regulation is published.”

The webinar recording is now available on-demand.  You can access it here:

EU MDR Strategies: How to Achieve a Market Advantage While Streamlining Regulatory Compliance

14Jan/19
Jumping

White Paper: Stop Managing Paper in a Data-Driven World

How Electronic Batch Records (EBR) Can Support Quality Metrics

By: Sandra K. Rodriguez, Market Analyst

Many life science companies have implemented manufacturing information systems as part of their automated manufacturing initiatives aimed at increasing product quality and lowering manufacturing costs. For many emerging and mid-market companies, however, paper batch records and a hyper-focus on compliance remain a reality. The result is a reliance on paper-based processes in a data-driven world.

Companies that have made the shift from paper to data-driven intelligence are aspiring to gain visibility by unlocking valuable manufacturing data to support quality metrics, as well as initiatives such as lean manufacturing, quality by design and continuous improvement. Companies that do not have access to this level of visibility should consider investing in the appropriate quality systems now. Regardless of their size, companies seeking to implement innovative electronic batch record (EBR) and quality management systems (QMS) now have a choice: either on premise or in the cloud.

Today the FDA intends to drive life science companies to harness data from manufacturing and quality systems and turn that data into intelligence. The Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) provides the FDA with the authority to conduct electronic inspections (e-Inspections) and target onsite inspections based on quality metrics.

Register to receive your complimentary copy of this White Paper.  We discuss:

  • Why Shift from Paper
  • FDA’s Request for Quality Metrics
  • Why Compliance and Quality Are Not the Same
  • The Role of Executive Leadership

This white paper was written by Axendia, Inc. and sponsored by MasterControl Inc.