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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.

Obtaining quality intelligence across the product lifecycle requires connecting decision loops.  MasterControl’s platform seeks to digitalize and enable actionable product quality insights from all organizational angles, resulting what the firm calls Product Lifecycle Excellence: 

  • Development – DHF & BOM, Change Control
  • Clinical – eTMF, CQMS
  • Regulatory – RIMS, Submissions, Registrations
  • Quality – Doc Control, Training and Audits
  • Supplier – AVL, SCAR, Audits
  • Manufacturing – eBR/eDHR, Traveler/Router, Equipment and Calibration Records
  • Post-Market – Surveillance, Complaints, eMDR

MasterControl takes an operator-first approach to improving data integrity, right-first-time production, product quality, line efficiency and plant profitability,” said Lowe.

Image Courtesy of MasterControl

Image Courtesy of MasterControl

 

MasterControl’s Manufacturing Excellence solution enables companies to build, execute, review and analyze shop-floor processes.  “Our digital production record fully digitizes shop floor data entry and production record execution so you can finally eliminate paper from your production environment,” said Brian Curran, SVP of Strategic Growth.

 

Some examples and benefits offered include:

  • Execute 100% digital production records
  • Deploy via mobile device or workstations
  • Improve data input consistency/accuracy
  • Access latest SOPs and work instructions
  • Enforce limits, controls and required training
  • Launch quality events and training in process
  • Automate corrections, verifications and signatures

In Brief 

In interviews with our Industry clients, we have witnessed more and more Life-Science companies seeking to implement digital integration strategies.  Digital integration across the product lifecycle supports actionable intelligence and insights based on data and analytics over paper-based and error-prone processes.    Manufacturing and Quality Excellence can only be achieved by managing the necessary organizational and culture changes while simultaneously applying best-of-breed technology solutions.

RELATED

We recommend companies stop managing paper in a data-driven world in our White Paper, sponsored by Master Control.  To learn more, request your copy here: Stop Managing Paper in a Data-Driven World.

Download your complimentary copy of this Briefing Note. 

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