A successful eQMS project is not simply about replacing a legacy tool with a shiny, cool new one. It’s also not solely about achieving regulatory compliance. While those are positive outcomes, they’re not the point of evolving your quality system.

Just like smart phones weren’t only an upgrade of the dial telephone and commercial flights weren’t merely a faster version of ships, your new eQMS needs to go far beyond its old-school counterpart. The significant time, effort and resources that  go into building and maintaining your eQMS should translate into a 10x impact on your business. 

Be bold: A reimagined eQMS can unlock the future of your business, so do not settle for  merely a better version of your past system.

Frame your eQMS project as a game changer

The goal of a eQMS transformation project should be seen within the context of your overall business strategy and designed so it effectively addresses your biggest challenges.

Each organisation will have its own variant, so here are a few examples:

Example 1: A high-growth business is challenged by scale and consistency. Onboarding a large number of new hires and ensuring that all are quickly and thoroughly educated about the company’s values, approaches and quality standards is a difficult task.

The right eQMS will evolve the business in several important ways.

  • Significantly shortens onboarding and training processes for new staff and even for whole teams (i.e. when work is outsourced or in M&A  scenarios). For example, consider how much time, budget and resources are saved when a new team member is fully productive in one month vs. three months.
  • Supports consistent cross-team performance.
    For example,  sprawling global support teams, who are empowered to perform consistently with the one operating out of corporate headquarters.
  • Increases the quantity and quality of documented knowledge, and the dissemination and usage of that knowledge.
    Imagine how much more productive and effective employees are when they have easy access to information critical to job performance.

Example 2:  An innovative med tech company wants to accelerate and improve the update release cycle for their medical devices.

The right eQMS supports getting newer versions of products out faster and more frequently, and impacts quality processes in a few important ways:

  • It becomes the backbone of the Agile+DevOps cycle, embedding the regulatory considerations as part of the iterative process. 
  • It provides the tools necessary for integrating design-controls directives into shorter version cycles.
    This means a new version of a given device can be released daily vs. monthly or even annually.
  • It provides an easy way to control the release at a glance.
    By utilizing a central dashboard that consolidates all the bits of information in one place, team members can quickly and easily assess statistics and spot discrepancies. This pain-free approach also supports full documentation, making it a snap to sign off on the release with confidence. 

Example 3: A life sciences company with several popular products receives a flood of post-marketing data.

The right eQMS can open the door to new opportunities culled from critical marketing analysis, surveillance and vigilance:

  • The right eQMS will listen on all incoming channels — including support calls, auto-generated analytics and crash reports on end devices — and consolidate the intelligence into a data lake.
    By tracking, analysing and aggregating this crucial data, new opportunities and challenges will swiftly surface.
  • Market insights allow you to better understand your customers, align with their needs and proactively serve them.
    Your brand will grow to be synonymous with quality and empathy.

 

Remember when you first started reading this post and were thinking of your eQMS as just a good way to save forests by cutting out paper use or as solely a way to stay compliant?

By devising and delivering an eQMS project using this new, bolder definition of success, you’ll find that the benefits are far more profound than you may have ever imagined.  When you take a company-level view that is much more strategic, you can save time, money and resources and significantly impact your company’s bottom line.