eQMS Consulting LLC

10/03/2025

09/16/2025

“We don’t need to validate this.”

You do. You always do.

Whether you perform the validation or it is performed by a software, validation MUST occur since the majority of this industry runs within a validated process.

Some Quality Management Systems provide built-in validation software, but anything that is done outside of those validated best practices will need its own validation approach. Whether it is a new form or batch import, the old saying ‘measure twice, cut once’ still rings true - always test your form in the validation environment, and then DOCUMENT your validation.

When an auditor asks about your validation approach, it’s way better to be able to pass over the documentation, than to be forced to say, “We didn’t validate that…oops.”

09/12/2025

Configure it Out: Stop Document Version Chaos Before It Starts

Yesterday, we helped a client prevent what could have been a compliance disaster. "Latest" ≠ "Current" in document management systems.

Utilize the 3-Check Rule. Before any document use, verify:
1. Revision number matches latest approved
2. Status shows "Released" (not draft/review)
3. Effective date is populated, and the archive date is NOT populated

A hashtag system provides a single source of truth for documents, training, and audit management - but configuration is everything.

The 15 minutes you invest in prevention today could save you 15 months of remediation tomorrow.

What's your first step going to be?

09/05/2025

We're getting super pumped!

Can't wait to see you all at MasterControl Summit 2025 🤩

08/28/2025

Strategic eQMS implementation requires more than software deployment - it demands operational transformation.

Most organizations focus on features while missing the foundational elements that ensure sustainable compliance excellence.

08/19/2025

MasterControl efficiency isn't just about process optimization—it's about interface mastery.

MasterControl Shortcuts:
• Quick Navigation - utilize the Quick Navigation icon to search and travel directly to any page in MasterControl.
• Tracking - Where is that document you sent for approval? Search within the tracking menu to see who is currently reviewing the document and what is needed to keep it moving along it's workflow.
• * - Utilizing the Basic Search, users can use the * to be a wildcard character for searching, i.e. "SOP-01**”
• Saved Searches - Using a complicated search over and over? Make sure to save it so it will load your parameters automatically the next time you need it.
• F5 - Waiting on someone to finish collaboration? Use F5 to refresh your screen while you have a coffee break

These fundamental shortcuts are the difference between using MasterControl and mastering it. Efficiency at scale demands elimination of unnecessary interface friction.

Your partner inquality excellence Success isn’t one-size-fits-all. eQMS Consulting designs adaptive quality management strategies that scale with your business and tackle tomorrow’s challenges today. View Services Your partnerin quality excellence Success isn’t one-size-fits-all. eQMS Consulti...

08/13/2025

Poor validation planning is like deploying without backups (you don't realize how screwed you are until audit time.)

Here's where everyone gets Master Control validation wrong:

• Treating validation as a final hurdle instead of building it into step one
• Writing test cases that check if buttons work, not if your business logic actually executes correctly against your specifications
• Thinking "out-of-the-box" means your customized AQEM form doesn't need validation (spoiler: it does)

eQMS Consulting builds validation into your implementation strategy from the start – not as an expensive afterthought.

Validate once. Validate right.

08/07/2025

Remember when you first implemented MasterControl and thought:

"There has to be a better way to do this"?

You were right.

As official MasterControl partners, we specialize in taking your system from frustrating to fantastic. From validation headaches to workflow optimization, we've seen it all – and more importantly, we've solved it all.

Let's turn your quality system into your competitive advantage.

02/13/2025

Melissa Leygan has been working in GxP since 2011 and specifically with MasterControl software since 2017. She has been an SME in MasterControl for most of that time.

📢 But wait, there's more! 📢

Now that there are certification tests for MasterControl sysadmins, she has fancy badges to prove it. Please join us in congratulating Melissa on her accomplishment! 🥳 🎉 🎊

01/02/2025

The goal is to optimize each part of your business, but what happens when the best practice in one area interferes with the best practices of another? How do you develop a solution that balances priorities in each area? Melissa Leygan answers these questions in her blog post, "What to Do When Optimization Conflicts With Process Needs", over at MasterControl's GxP Lifeline, where she lays out a framework for generating the best solution for your particular needs.

💡 Check it out! 💡

https://lnkd.in/geJS6yBY