Tag Archives: MasterControl

30Sep/19
MasterControl-250x250

Quality Can Only Improve… IF We Allow the Information to Focus on Providing Quality Products

MasterControl Briefing Note

By: Sandra K. Rodriguez, Market Analyst

Axendia was recently briefed by the Executive Team at MasterControl.   The company’s mission is to make life changing products available to more people sooner.   One way MasterControl is setting out to achieve its mission, is by enabling its Life-Science customers to obtain what it calls Product Lifecycle Excellence (PLx).  With over 650,000 users spanning more than fifty countries, MasterControl is well positioned to bring a much needed correlation between Product Lifecycle Management (PLM) and Quality Management to the Life-Science industry.

The Need to Connect Decision Loops

Companies typically have quality data spread all over the organization.   Paper-driven production processes on the shop floor are also still a reality in many companies.  These pockets of quality data, when consolidated, have the potential to offer valuable insights to product quality data across the entire lifecycle.  With PLx, MasterControl is seeking to close the gap in the digitalization of the manufacturing environment.   “We looked at how to build an application that is easy for operators to adopt and use, easy for manufacturing environments to deploy and connect to their other systems.  And, in the process, completely eliminate paper off of the shop floor,” said Matt Lowe, Executive Vice President at MasterControl.

Another reality is that although advances in PLM and Manufacturing Execution Systems (MES) have been rolled out over decades, QMS data is often siloed and paper still exists on the shop floor.  The result is a disconnect in information that may range from clinical study quality issues to poor shop floor data integrity.  Additionally, complaint data is often times not looped back into the organizations’ overall quality system.   “Being able to launch quality incidents from the shop floor, enforce training and fill the gap between ERP, MES and LIMS allows companies to achieve next level digital manufacturing excellence and that’s what we’re pursuing,” said Terrance Holbrook, Director of Product Management. Continue reading

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.