8 System Requirements for Extending Quality Across Expanding Ecosystems

Many hands make light work, as the old saying goes. For businesses facing the pressure of accelerating timelines, the increasing complexity of products and a host of other challenges in modern life sciences environments, contracting with specialists who can help them lighten the workload is a necessity. To maintain cost-effective operations, life sciences companies across the board are increasingly adopting asset-light models that rely heavily on a broad ecosystem of design, research and manufacturing organizations.

Outsourcing a variety of functions across distributed supply chains is much more than a trend in the life sciences. It is now an imperative for any company that hopes to stay competitive and within budget. It’s also a common practice that shows no sign of losing popularity or effectiveness. In fact, the latest research from Accenture Life Sciences indicates that 91% of life sciences companies 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.(1)

When an organization extends its network of production sites and outsourcing partners, however, quality is always the first thing to suffer if it’s not made the top priority. Even if a company has a strong internal culture of quality, extending that quality structure and maintaining consistent quality practices throughout geographically dispersed sites becomes exponentially more difficult as additional contractors are thrown in the mix.

As companies’ ecosystems proliferate, the rapid expansion is shining a light on a variety of quality deficiencies. Three statistics in particular should raise alarms for any organization that needs to establish satisfactory control over and visibility into the quality activities taking place throughout its ecosystem of contractors:

• 40% of organizations report a lack of control over CMOs’ product quality.(1)
• 60% of organizations struggle with real-time visibility into their CMOs’ production. (1)
• 74% of quality process end users report that launch delays of products and services are frequently caused by inflexible quality processes.(2)

As supply chains continue to expand in every corner of the life sciences, it’s becoming clearer that quality departments must find new ways to increase flexibility and collaboration across growing numbers of external partners. In an industry that values product safety and quality above all else, however, it’s critical that enhanced collaboration and improved flexibility does not come at the expense of increased risk. To effectively maintain dynamic, asset-light operations that don’t jeopardize the compliance of their products, life sciences companies must be able to outsource the requisite functions while upholding rigorous standards of quality.

8 Keys to QMS Extensibility

Keeping pace with the dynamics of an expanding ecosystem can only be achieved with quality management tools that ensure the consistency of your quality management competencies. As your organization’s quality ecosystem matures and broadens, it needs a commensurately effective quality management system (QMS) that can promote flexibility and responsiveness. And while all QMS solution providers make claims about their products’ data and process management improvement capabilities, the proof lies in the real-world results they can help an organization achieve.

To determine if your quality system — or the system you may be thinking of investing in — is capable of effectively extending quality across a maturing ecosystem, consider how it stacks up when you ask the following critical questions:  

1. Does it have the level of configurability necessary to meet your business needs?
2. Does it have the modularity and integration features your business requires?
3. Does it incorporate risk-based analysis?
4. How quickly can upgrades, patches, new features and enhancements be implemented?
5. How burdensome is the validation of the system?
6. Can the intelligence the system provides be personalized according to your users’ roles?
7. Is it conducive to adapting to the requirements of regulatory innovations and emerging technologies?
8. Is it geared toward facilitating the future expansion of your business?

Quality-focused organizations are finding that satisfactory answers to these questions are typically accompanied by an increased investment in advanced digital tools. To effectively extend quality, quality leaders need tools that enable them to seamlessly connect their quality data and uphold the consistency of processes throughout their outsourcing networks. Feedback from executives and quality managers recently surveyed by BCG indicates that those at the vanguard of these efforts have discovered that successful implementation of advanced QMS solutions corresponds not only with expected improvements to the management and quality of data, but with enhancements to their analytics and methodologies as well. (3)

Quality leaders who commit to making these improvements can expect big returns in each area of the value chain, according to BCG’s forecasts. The firm’s “Quality 4.0 Takes More Than Technology” report projects that such digital enhancements “will boost quality performance through improvements in visibility and through insights derived from connected data, as well as by extending control beyond the four walls of the factory.”(3)

The companies BCG classifies as digital frontrunners — organizations in which a total quality management culture is prevalent and quality enhancement initiatives are viewed as long-term investments — are far outnumbered by those lagging in their modernization efforts, however. Only 16% of those surveyed reported that they are applying advanced digital technologies to enhance traditional best practices in quality management.

Leading-edge organizations that are past the planning stages and have already begun implementing digital technologies are already realizing the important gains that can be made in the areas of quality governance, performance management and training. According to the BCG report, the companies that are best-in-class in these regards are not only making quantifiable improvements, they’re also understanding and developing the most important capabilities while actively rolling out digital use cases.

Achieving Truly Connected Quality

Quality cannot effectively operate in isolation. While this is not news to any life sciences professional who recognizes the value of quality, it’s a fact that becomes glaringly apparent as a company outsources more of its essential functions. Quality must be consistent and pervasive throughout the supply chain if it is to be managed comprehensively and for compliance to be sustainable. To have the capacity to maintain comprehensive control and complete oversight over quality, an organization must maintain continual visibility into all quality activities as they’re occurring in real-time throughout the entire ecosystem. 

Enhancing the consistency of and visibility into data requires not only a platform that enables the organization to digitize, automate and connect quality processes internally, but one that leverages modern integration capabilities that facilitate extensibility. Involving additional sites and contractors means that more systems are in use, too. The organizations that life sciences companies contract with routinely employ a variety of systems as part of their business-critical stack, such as laboratory information management systems (LIMS), manufacturing execution systems (MES), enterprise resource planning (ERP) software and supply chain management (SCM) systems. Data flows through each of these disparate systems, and maintaining data synchronization across them all is impossible without proven digital tools that can integrate information from multiple systems and keep it up to date.

As a result of companies’ dire need for synchronized, real-time data, quality leaders are turning to digital platforms that ensure that all parties have access to a single source of truth for quality data and that maintain the consistency of quality processes between sites. This industry need was the driving force behind the partnership between MasterControl, a leading provider of quality and compliance solutions, and MuleSoft, the world’s leading integration platform as a service (iPaaS) provider. The adaptability afforded by the companies’ joint iPaaS integration offering augments MasterControl’s capacity to provide simple and reliable integrations of critical information between enterprise systems and outsourcing partners’ data sources. Adding an iPaaS layer to the proven MasterControl QMS gives quality and compliance professionals the visibility and control they need to ensure quality and maintain compliance across multiple sites and partner organizations.

To learn more about leveraging digital tools and advanced integrations capabilities to connect quality data and processes throughout your organization’s flourishing ecosystem, download “The Ultimate Guide to Connected Quality Data.”

Resources

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.
3. “Quality 4.0 Takes More Than Technology,” BCG, Aug. 20, 2019.