Reduce complexity and improve visibility using QMS to unify and standardize data and processes

Complexity is a primary concern for manufacturers who aim to reduce quality-related costs and risk and to improve compliance.

Comprehensive enterprise systems such as EQMS, ERP, and document management can help to standardize certain processes and offer operational visibility and control that can be useful when tracking, analyzing, and managing quality—to a point.
Even the most effective of these systems can be limited by data isolation.

This problem is often compounded when an enterprise undergoes a merger or acquisition.

Disparate systems and quality processes can easily increase complexity and further silo important quality data, limiting visibility and standardization both within and across facilities.  
This can be addressed through a quality management system (QMS) that enables enterprise-wide integration and accommodates a wide range of requirements.

The Cost of Standalone Systems

When different manufacturing facilities use different quality processes and QMS solutions, it becomes increasingly difficult to get a consistent view of quality across the enterprise. Data becomes siloed, preventing the type of historical analysis that can lead to proactive quality management. And if any of those systems lack the ability to automate data collection or integrate with operational systems like ERP or MES, the likelihood of human error during collection or analysis increases. As a result, your quality information—and the actions you take based on it—could be outdated, out of sync, or downright inaccurate.
Taking steps to standardize around a single, robust, modernized QMS requires investment and organizational buy-in. But the cost of doing nothing is often much greater.

  • Maintaining a variety of hardware and software solutions from different vendors reduces your enterprise’s purchasing power.
    • A consolidated system enables you to take advantage of discounts and economies of scale.
  • Home-grown quality systems, or outdated systems that have been “improved” by custom add-ons, increase IT burden, learning curves for operators and integration challenges.  
    • A SaaS solution that is designed to integrate with multiple vendors can provide faster deployment and validation, increased usability, scalability, and access to continuous updates.
  • A lack of integration creates inefficiencies and increases the proportion of time spent on manual tasks, such as rekeying data. Interruptions in the flow of information cause blind spots that can hide performance issues.
    • Consolidating quality activities on a single platform that can seamlessly integrate operational data provides the kind of end-to-end visibility that helps to optimize performance.

Integrate Systems to Increase Visibility

Fortunately, the availability of enterprise cloud QMS solutions, like TrackWise Digital, is making quality standardization easier than ever. Manufacturers can now achieve new levels of operational integration, coordination, and cost-efficiency without compromising compliance.
Cloud-based ecosystems—where a single platform or architecture supports a range of compatible software from a variety of vendors—can significantly reduce the fragmentation and friction that prevents many organizations from optimizing quality processes and insights. Standardizing around a digitally mature, enterprise-wide quality management platform that integrates with ERP, LIMS, and MES systems and automates processes offers multiple benefits:

  • A level of visibility, control, and data integrity needed to meet or exceed regulatory standards
  • Access to both real-time and historical data to help quickly identify and address potential quality issues—leading to reduced costs and recalls
  • Significant cost savings during configuration and validation
  • Elimination of customized applications and associated costs
  • Simplified reporting, communications, and data entry, leading to greater productivity
  • The ability to share, aggregate, and analyze data, both from within the organization and from partners and suppliers
  • Instant scalability without a heavy front-loaded investment

The Time Is Right

If you’ve just completed a merger or acquisition, there’s no better time to evaluate your quality approach and standardize around a single, robust platform.

Look for these hallmarks of a digitally mature, unified QMS:

  • Support for integration with multiple vendors and systems via open standards-based web services, to allow for interoperability among enterprise systems and communication of data with other systems
  • A single, electronic source of truth for quality management processes and data, with data from integrated systems flowing seamlessly into the platform
  • The ability to capture original data sources, making the information attributable to a specific system (e.g., manufacturing data from MES)
  • Reporting capabilities that enable users to track and trend quality data, identify patterns and make decisions directly from within the QMS
  • Visibility ranging from a high-level view of process performance to more granular details of specific corrective actions, delivered on a pre-set schedule  
  • Recording and reporting of information in human readable terms, in accordance with regulations such as 21 CFR Part 11 

The adoption of this type of QMS across the enterprise will enable you to reduce complexity and optimize quality processes across every manufacturing facility.