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Lexi Sharkov08/29/234 min read

Buying vs. Building your eQMS: Which is Right for You?

Have you ever made it halfway through a DIY project and caught yourself wishing you had hired a professional? We’ve all been there – but it’s not a feeling you want to experience when your audit-readiness and compliance are on the line. That’s why you’ll want to think twice before committing to building an in-house eQMS. An in-house system could work in specific cases, but make sure you know the potential pitfalls before you decide between an in-house eQMS or a third-party vendor. 

What is an in-house eQMS?

An in-house eQMS is a quality management system that you’ve built from scratch specifically for your own company, often with the help of your internal IT and development teams. This type of homegrown eQMS is more than just an Excel spreadsheet. Instead, it’s a custom coded app or software built on a database system (such as Microsoft Access). 

If you have a pretty robust IT team, an in-house eQMS can come with some perks. The first – and probably the most important to leadership – is cost. With a homegrown solution, there’s no annual cost to maintain the program beyond what you’re already paying your developers. The second biggest advantage is feature flexibility. If your quality requirements are nuanced (and we mean really really nuanced), a custom eQMS might help you get exactly what you need. 

But while an in-house eQMS might seem enticing at first, we wouldn’t recommend it for many companies – and not just because we’re an eQMS vendor. We’ve talked to a lot of quality teams who have used homegrown solutions, and these are the 3 biggest reasons why they’re making the switch to a third-party eQMS software:

1. The Quality team is dependent on the IT department.

A configurable eQMS is important for the Quality team. Why? Imagine you roll out a new product that requires a different process for documenting regulatory reporting. Or maybe you acquire a new site location that has a completely different workflow or audit requirement. It’s time to reconfigure your eQMS to match.

There are lots of reasons why you may need to reconfigure or update your eQMS, but with an in-house software, you’re relying on your internal IT team to make the changes. That could mean waiting months while they tackle other tech priorities across the company. And when your ability to support an audit or address an observation is put on hold, that’s a problem.

We mentioned above that an in-house system can come with feature flexibility, but the system usually becomes rigid after the initial build. The right eQMS vendor will have a highly configurable system, which means you still get a flexible platform to meet your niche requirements while also giving you the ability to make ongoing updates at an audit’s notice. Plus, a third-party vendor will make consistent updates based on industry trends, customer feedback, and opportunities for continuous improvement, letting your IT team focus on other priorities across the organization.

2. In-house systems rarely work well together.

When quality systems are built in house, they’re usually done in a piecemeal approach. You build a document management system, a separate training management system, a separate change control workflow, etc… and this makes sense. Creating stand alone apps that work together and talk to each other is hard, and building an integrated system would require a lot more time and resources than your IT department may be willing to devote to one project.

But these disparate systems don’t speak to each other. That means after updating a document, your Quality team then has to navigate a different system to update the training attached to that document, then another one to update the change control, and so on. That’s a lot of extra time, effort, and room for human error. Plus, it makes navigating system upgrades much more difficult. Requesting an update to one system means your IT department now has to devote time to changing all of the others that are impacted individually.

An all-in-one third-party eQMS makes it easier to automate updates across the platform and is built to keep all of your processes running smoothly together.

3. It’s harder to meet the standards for an audit trail and software compliance.

The FDA requires the companies it regulates to validate the software they use, including eQMS, eLMS, doc management systems, etc.. This is to make sure the software you’re using meets the standards for data privacy, consumer safety, and in general, functions the way it's intended.

For regulated companies, these compliance requirements can be pretty complex, and building a system from scratch that meets these standards is difficult. If your IT team isn’t well-versed in regulations like the 21 CFR Part 11 and EU Annex 11 standards or SOC 2 Type II, ISO certifications, future audits are going to be unpleasant to say the least.

By working with an eQMS vendor, you know the development team is 100 percent dedicated to building a system that is compliant and you can trust they know the regulations inside and out. Plus, they likely have their own internal Quality team that’s staying up-to-date on the latest regulations and informing the IT department of necessary changes.

Partnering with a good third-party eQMS vendor means your Quality team gets to own the keys to the quality castle, quickly adapt to changes, and easily define the processes that match your needs. That’s good news for automation, efficiency, compliance, and your team’s sanity.

Still curious about the pros and cons of an in-house system or need help convincing your CFO a third-party system will save resources in the long run? We can help with that