Tag Archives: QMS

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.

 

15Nov/18
IoT Image

See Who’s Soaring to the Cloud in Support of Quality and Compliance

Companies Are Taking a Cloud-First Approach

By: Daniel R. Matlis, President and Sandra K. Rodriguez, Market Analyst

Life-Science organizations have implemented on premise electronic Quality Management Systems (QMS) for decades to support regulatory requirements and replace paper-based processes. These systems were often implemented to mitigate regulatory findings and in response to the “Whack-a-Mole” relationship between Industry and Regulators.

WHACK A MOLE

As a result, many companies implemented “Paper on Glass”, simply duplicating existing paper quality processes in electronic QMS. This approach created an environment of a mixed bag of disparate eQMS installations throughout the enterprise that have high degrees of customization. Now, IT and quality teams are faced with the daunting challenge of upgrading, migrating, and validating outdated legacy on premise QMS systems.

However, based on Axendia’s primary research on the adoption of Cloud QMS in the Life-Science Industry, we quickly determined that companies large and small, are taking a different course and are soaring to the modern cloud.

Our latest Voice of the Customer Report highlights interviews with 10 industry executives and represents 3 innovative Cloud QMS vendors.  This comprehensive reports outlines:

  • Why Cloud is No Longer Taboo
  • Clouds Come in Many Shapes and Sizes – Not All Clouds are Created Equal
  • Executive Accounts of Cloud QMS
  • Why Life-Science Companies Are Moving to the Cloud
  • End-To-End Cloud QMS Capabilities
  • The Pros, Cons and Pitfalls to Avoid
  • Recommendations and Thoughts to Consider

You are welcome to download your complimentary preview here.

To request the full report, please contact: Axendia Research.