Lexi Sharkov12/11/245 min read

Resource Roundup: How do you get the Quality Management tools you really need?

Pop quiz: Which of these things is most important to a successful GxP-regulated organization:

Effective, efficient training.

Strong, company-wide compliance.

Smooth, successful audits.

Fewer costly delays.

If you chose secret option “E. All of the above,” you passed. And you just proved why an electronic quality management system is critical. QMS software makes each of these things possible without putting more strain on the Quality team. That’s a win-win for everyone.

So why do quality teams often struggle to secure budget for the quality management tools their organizations need?

Most of the time, it’s because the benefits get lost in translation.

To get leadership onboard with a QMS software investment, you have to speak the language of the C-suite. That means focusing on data, business impact, and the ROI of an eQMS.

As part of our eQMS University series for Quality Management teams, we covered these exact topics with Quality leaders who have seen the impact better quality tools can have on GxP organizations – and know how to work with the C-suite to get them.

Take a look at the highlights from two of our eQMS University webinars below.

Using Data to Help Showcase the Value of Quality

Quality teams have access to a lot of GxP-critical data. And with the right eQMS, they can find – and report on – that data in a way that fuels continuous improvement for their organizations; a huge focus for the C-suite.

In our eQMS University webinar featuring Sandy Hedberg, VP of Quality and Regulatory Affairs at ARC-One Solutions, we covered:

Why Quality metrics matter
Best practices for tracking Quality data
How to report Quality metrics to leadership
How Quality teams can use metrics to advocate for the quality management tools they need

Overheard at eQMS University...

Panos Boudouvas: A lot of critical processes are defined, organized, and checked by quality teams, like document reviews, throughput time, deviation investigations and response times. And these are metrics that any good quality system should give you on a regular basis. Are those the data points that get the most attention from the C-suite or from department leads?

Sandy Hedberg: Yeah, usually, because those usually are the ones that affect your bottom line, right? And it's the most visible to them. It’s easy to see, “I've got X number of products that I tried to make, but I could only make 20% of them because of these issues.”

But there are some “soft” metrics, or other KPIs that they need to think about too. You’ve got your reputation. You've got bad publicity that could happen. There are a lot of things that could happen if you're not tracking some of your other KPIs and making sure they’re in the range of acceptable.

One of the most important takeaways from Sandy's session? Getting leadership buy-in will take more than an email with a few Quality data points. Take time to explain the story the data tells, the impact on the business, and the reasoning behind your Quality activities. That's how you build the foundation for a culture of quality.

Want more tips on tracking quality metrics and using data to make the case for the QMS software you need? Check out Sandy's full eQMS University webinar on-demand here.

Making the Case for an eQMS to the C-suite

Quality teams can be their own worst enemy.

Their ability to “grin and bear it,” and their quiet, steadfast commitment to compliance means they can often pass audits and manage quality at a basic level even without the right tools.

But how long is “good enough” actually good enough when it comes to quality, risk, and ultimately, consumer safety? Quality leaders have to figure out how to make their leadership teams see the importance of investing in better quality management tools… before it’s too late.

We know half of the equation is data. The other half? Messaging.

That’s why we chatted with Tim Reinhardt, a Quality leader with over 30 years of experience at GxP-regulated organizations both big and small, about what works – and what doesn’t – when advocating for more resources for the Quality team.

In Tim's webinar, we covered:

How to get the C-suite to understand the risk of a manual QMS
The impact of an eQMS on due diligence and an organization's risk management
How to get leadership buy-in for a better quality management tool
How to communicate the ROI of quality

Overheard at eQMS University...

What does the C-suite need to understand about the risk that comes with relying on a homegrown QMS instead of investing in an eQMS?

Tim Reinhardt: Most of the time when I see a multitude of systems, say Sharepoint or something similar, information is usually stored but not cataloged. Then, when you need the information, it's not available.

I work on a lot of projects where it's really critical to go back a couple of years and see reports and [with a manual system] it's just really impossible to catalog and to do an easy search. The information could even be lost completely. That’s a huge risk, and that could introduce a big cost if studies have to be redone or information has to be regathered.

Sometimes certain groups will think “no, no, we have all this information,” but it’s a false sense of security. Because then, during due diligence, you're getting questions and you're not able to answer them or provide info from a quality management system.

That slows the process down, and it leaves a lot of questions about risk. It could impact the company in many ways.

Panos Boudouvas: It does create moments of doubt… and that might become a lost sale to your company, or it might become something more severe if it's a regulatory inspection.

Ready to make the case to get the QMS software that will support your team and protect the future of your organization? Watch the full eQMS University webinar here.

Lexi Sharkov12/17/242 min read