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GxP Lifeline

How to Align Quality Across an Expanding Ecosystem


The modern asset-light business model isn’t simply a trend. Organizations are becoming more and more reliant on an ever-widening range of geographically dispersed contractors, partners, vendors and business units. It’s become a practical necessity for companies of all sizes.

This movement has been particularly prevalent and shows no signs of slowing down in the life sciences, where more than 90% of organizations plan to expand their use of contract manufacturing organizations (CMOs), contract packaging organizations (CPOs) and contract development manufacturing organizations (CDMOs) over the next three years, according to Accenture’s market study. (1)

Examine How Outsourcing Impacts Quality

While outsourcing has become an increasingly cost-effective means of operating in the life sciences and many other business sectors, it is not without its challenges. As a company’s network of contractors and/or business unit locations grows, so do the subsequent complexities of keeping the various entities on the same page. Maintaining harmonized and consistent practices and protocols among the various sites in the ecosystem poses monumental challenges, chief among them being the difficulty of aligning quality across multiple sites.

If your organization’s ecosystem of contractors is expanding, the following quality challenges may sound familiar:

  • Product launch delays are frequently caused by inflexible quality processes, according to 74% of quality process end users cited in Gartner research. (2)  
  • Real-time visibility into CMOs’ production is a problem for 60% of life sciences organizations surveyed by Accenture researchers. (1) 
  • A lack of control over quality is an issue for 40% of organizations with an ecosystem of contractors. (1)

As companies’ networks grow, they must come to terms with two truths that quality professionals have always understood:

  1. Quality cannot effectively operate in isolation.
  2. Quality is the responsibility of everyone in the organization.

Learn How Your Expanding Network Can Harmonize Quality

In a webinar on July 15 at noon Eastern time, MasterControl Executive Vice President of Product Matt Lowe will explore the quality challenges posed by flourishing business ecosystems. The exclusive MasterControl webinar, titled “The New Ecosystem Dynamics: Digitization as a Driver of Global Quality Alignment and Innovation,” will provide tips on how your organization can standardize and unify quality activities and examine the critical factors involved in extending a quality management system (QMS) enterprise-wide.

Lowe will be joined by Matthew Seitz-Paquette, North America quality specialist at Fagron, a global leader in personalized medicine and pharmaceutical compounding, who will discuss some real-world QMS applications based on his company’s experiences. Seitz-Paquette will underscore the power of QMS extensibility by relating how Fagron has leveraged digital tools to align quality processes between multiple global sites, improve right-first-time metrics and streamline its training and compliance processes.

Seitz-Paquette and Lowe will cover the many ways advanced technology platforms can help companies expand quality’s footprint while also enhancing their control over operations and data. They’ll also itemize the eight hallmarks of an effective QMS that attendees can apply when assessing their existing quality systems or use as a barometer when evaluating the digital QMS solutions available on the market.

The presenters will share their quality experiences and knowledge about the advantages beyond alignment that can be realized by effectively connecting quality data and processes via robust platforms, such as:

  • Ensuring current, accurate and audit-ready information is readily accessible to staff, outsourcing partners and regulators alike.
  • Increasing visibility into all quality activities.
  • Leveraging risk-based thinking to enhance operational flexibility.
  • Establishing a single source of truth for information.
  • Adapting to the breakneck pace of evolving technologies and regulations.
  • Positioning your company for growth and business expansion.

Don’t miss your chance to join the exclusive presentation on July 15. Register for the webinar today. If you’re unable to attend the live event, register to receive a recording of the webinar. 

For a sneak peek into some of the topics that will be covered in the presentation, download MasterControl’s “Ultimate Guide to Connected Quality Data” e-book and learn about the many benefits of connecting quality data across the product life cycle.


  1. "Dare To Be Different: It’s time to revamp collaboration in life sciences contract manufacturing,” Accenture Life Sciences, 2019.
  2. "Reimagining Quality Processes for the Digital Era,” Gartner Quality Research Team, Nov. 1, 2019.


James Jardine is the editor of the GxP Lifeline blog and the marketing content team manager at MasterControl, Inc., a leading provider of cloud-based quality, manufacturing, and compliance software solutions. He has covered life sciences, technology and regulatory matters for MasterControl and various industry publications since 2007. He has a bachelor’s degree in communications with an emphasis in journalism from the University of Utah. Prior to joining MasterControl, James held several senior communications, operations, and development positions. Working for more than a decade in the non-profit sector, he served as the Utah/Idaho director of communications for the American Cancer Society and as the Utah Food Bank’s grants and contracts manager.

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