I recently posted on LinkedIn about a conversation I had with a frustrated quality leader. They had tried multiple times to get approval for an electronic quality management system (eQMS), and been turned down every time. Meanwhile, it appeared that the company’s production team was getting whatever it wanted, no questions asked.
Based on the response I got from that post, it seems a lot of people have the same frustration.
There’s no reason why the Quality team should be pushed to the side. They help everyone get credit and approval for all their hard work. No one wants years of effort thrown out because the company didn’t follow the processes the way the regulator requires.
An eQMS is an essential tool for every Quality team, and it makes no sense that Quality leaders are being forced to stay on paper.
It seems to me that many Quality professionals struggle to communicate their need for an eQMS in a way that resonates with the leadership team. Let’s be honest, it’s hard to ask for money, and Quality professionals have their minds focused on compliance and regulations, not on selling themselves and their needs.
I’ve seen a number of Quality leaders make this argument: “An eQMS will save me a lot of time and will help us be more compliant. Here is the cost, can this be approved?” This line falls flat, time and time again because it does not speak in terms that the leadership team values.
There’s an art to making the argument for investing in a Quality system, and from watching many Quality leaders advocate for this successfully, here are a few approaches that work:
1) The Cost of Non-compliance: Just telling the CEO or CFO that your current manual system will put the company at risk in an audit of non-compliance is not that compelling. You have to paint the picture in a way they understand.
It’s easy to make errors in a manual system, most of which can be avoided with an electronic system. What are the financial implications of a failed inspection/audit? How will that slow down your time to market, especially as it relates to your competitors? If you’ve reached the commercial stage and have a poor audit, how will that impact the bottom line? Will you be able to repair the damage quickly before you start losing customers? Can you survive poor public perception?
Your C-suite might not care about how an eQMS makes the Quality team’s job easier or more efficient, but they will care about lost revenue and disappointed customers. Make it clear to them that at its core, an eQMS is really a revenue protection system. Investing in an eQMS now is a lower-cost investment compared to throwing money at the problem when there’s a non-compliance emergency.
2) Increasing Efficiency: With a paper or manual quality system, employees waste an immense amount of time hunting for documents, signing off on training, logging a deviation, and chasing people down to get a signature on the change control. I've had clients tell me they spend 6-8 hours getting documents approved manually and filed in the correct shared folder. Every moment spent on these extra tasks takes away from revenue-generating activities for the entire company, not just the Quality team. An eQMS takes care of this in minutes, not hours.
3) Attractiveness to New Hires and Internal Satisfaction: Today’s workforce expects everything electronic and accessible with a click of a button. Cultures that focus on manual and paper-driven processes seem archaic and old-fashioned. Why would a top candidate choose an organization stuck in the past? Experienced professionals are looking to join forward-thinking companies that invest in the tools that make their jobs easier and will leave/avoid companies that do not.
4) Hiring Costs: Although operating on a manual system might work now, what happens when your company doubles in size? This is a hidden factor that comes with staying on paper that your C-suite may not have considered. Will you have to hire a new Doc Control coordinator or a new training coordinator? What is the people-cost of maintaining a manual system as you add more staff, off-site locations, and complexity? It’s difficult to scale with paper, whereas with an eQMS, document control and training are easily accessible and organized across the entire enterprise.
5) Less Painful Audits: For heavily-regulated entities, every audit done on a manual system is a resource-intensive experience: document runners sprinting to pull things from the archive, multiple people in the room managing the requests of the inspector, and the whole team cringing in hopes that they won’t find the skeletons in the closet. And this can last for days. With an eQMS, the audit is painless and requires fewer resources. It’s easy to find necessary documents and show that your company is in compliance.
If you position an investment in an eQMS as a critical tool for the entire organization, not just the Quality team, and highlight the time-, money-, and resource-saving benefits listed above, you’ll have an easier time making your case to Leadership.
There are many eQMS systems out there and all of them are better, safer, and more efficient than paper. I am biased being that I work with the Sales team at ZenQMS, but I’ll share what I think are the reasons why ZenQMS is the best system if you are trying to convince leadership to make an investment in an eQMS:
1) Simple/Transparent Pricing: We do not charge by seat licenses or by module, so everyone has access to the full system on Day 1. For the C-suite, this means that they do not have to be concerned that you will come back for money again in a year as you need more functionality or licenses. And they’ll have clear visibility into the cost for your lifetime with ZenQMS. This is one of the benefits that Veru Inc. appreciates about our pricing structure.
2) Ease-of-Use: One thing we often hear from clients like Selux Diagnostics, is how easy and intuitive ZenQMS is to use, especially for the general user. Your leadership team may think they want all the bells and whistles, but what good are they if it results in a cumbersome system that requires having to hire more people to manage it. They certainly won’t want to use it themselves. And neither will your team.
3) Lifetime Support: We don’t charge for support by the hour. Your system implementation and ongoing support are all included in the proposal, which means that, just like TriRx Pharmaceutical Services, you can rest assured that a ZenQMS representative will respond quickly to your requests without additional charges.
4) Configurability: ZenQMS wasn’t built on top of rigid templates. You are able to configure the system to match your current preferences. Especially in modules with change control/issues, you can design and enforce your own processes for CAPAs, deviations, complaints, doc change etc. right in the application rather than having to fit into someone else's box. ZenQMS provides you with the tools to create and change those processes all on your end. You don't have to call us whenever you add a new dropdown option or roll out a new process. We designed ZenQMS to be configurable because we were quality professionals before we were software developers. We understand that you should be able to design the system around your preferences, not the other way around.
We understand how difficult your job is now, and you should be commended for doing so much on an outdated system. We also understand that making a pitch for the ROI of an eQMS is hard, but you deserve it. Our team is always happy to help you think through it and put yourself in the best position for approval. Reach out to email@example.com and let us know how we can help.