ATTENTION: FUTURE CAPA PROS
Download your FREE Checklist!
This checklist is here to make sure every investigation report you write is spot-on—compliant, clear, and complete—so that you easily get that approval nod!
Whether you're the one writing, reviewing, or giving the final thumbs-up, this checklist will help you catch any gaps, improve the quality, and make sure nothing gets missed.
Ready to dive in? Let’s go!
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“Elevating compliance of CAPA Systems by empowering and unleashing the full potential within every single quality professional”
CAPA Empowerment & Learning
Through Simplicity
Does CAPA, Root Cause Analysis and Investigation Reports feel like one big headache for you and your team?
Ready to say goodbye to stress and hello to success?
You’re not alone — I’ve got your back!
I’m here to help you simplify it all and give you the tools to build a confident, empowered and skilled team that gets it right every time.
It's time to make CAPA something your team handles with ease, so you can focus on what really matters—
Running a successful business in the regulated world!
MEET THE FOUNDER of capa made easy
Hey, I'm Laisa Denise!
Proud entrepreneur, mommy, Engineer from Puerto Rico and creator of CAPA Made Easy. My mission is to help quality leaders and professionals in regulated industries simplify the complex world of CAPA, Root Cause Analysis and Investigation Reports, so they can lead teams with confidence, stay compliant, and avoid costly mistakes.
I know how overwhelming and stressful implementing CAPA Plans, solving problems to find the proper root cause and, writing robust investigation reports can feel... especially when you’re under pressure to get it right.
That’s why I create simple, easy-to-follow custom digital courses and training that helps you and your company:
Eliminate the fear of non-compliance and its consequences, including recalls, fines or loss of customer trust.
Have a go-to trusted resource to properly train your team, closing knowledge gaps and leaving them fully prepared.
Write investigation reports that auditors love.
Avoid regulatory observations that could lead to financial penalties or damage your company's reputation.
My Custom Digital Courses are Perfect For...
You want tools and resources to build an empowered, compliant team that feels confident in their CAPA, Quality or Investigator roles, identifies true root causes easily and writes clear, complete investigation reports... reducing stress and confusion.
You worry about your team's lack of experience with CAPA systems, you feel the frustration of recurring quality issues, and the pressure of ensuring your team is always audit-ready.
You're just starting out. Understanding the CAPA system, finding root causes and figuring out how to document investigations feels a bit overwhelming.
You might be thinking, "How am I going to learn all this?". Believe me, I've been in your shoes, and I know how tricky it can be to get the hang of the regulated industry requirements.
You want to contribute effectively and perform your daily tasks without feeling overwhelmed, without having constant oversight, reducing rework and ensuring smoother investigation report approvals and CAPA Plan implementations without all the back-and-forth.
You might be asking yourself, "Will I be able to catch up quickly?". Trust me, I know exactly what you're going through.
ATTENTION: CAPA PROS and quality leaders
Download your
FREE Cheat Sheet!
Ready to tackle any problem with confidence?
In 'Problem Clarity Made Easy', I’ll show you and your team two simple steps to define issues clearly and effectively—so you can solve them like a pro!!
No stress, no confusion, just results...
Let’s go!
By entering your info, you’ll become a CAPA Made Easy Insider — with emails, FREE access to exclusive insights, private Q+As, and inspiring episodes of the new CAPA Made Easy Podcast (coming soon), delivered with 💜 to your inbox.
(Unsubscribe anytime in a click.)
Having a Competent Team Matters
Let’s be real—having a strong, empowered and skilled CAPA team is the key to success in regulated industries. Here’s why:
Stay Out of Trouble with Regulators
Mistakes in investigation reports or root cause analysis can trigger audits, findings, and even product recalls—costing your company time, money, and trust. But with a team that knows how to write clear, thorough reports and pinpoint real root causes, you’ll spot issues early, solve them for good, and handle audits like a pro.
Stop Recurring Quality Issues for Good
If the same quality problems keep popping up, it’s because the real root cause wasn’t found. I’ll teach your team how to dig deep and solve problems systematically once and for all.
Save Time and Stress
A well-trained team knows exactly what to do. That means quicker investigations, faster report approvals, effective CAPA Plans and less stress for everyone.
Build Confidence and a Stronger Team
When your team is confident in their skills, they work better together, feel less stressed, and deliver consistent, high-quality results.
Does this sound familiar?
"The trainings out there are too generic and do not relate to our industry and processes. They do not speak our company's language. Our employees just leave with more answers and cannot apply what they learned."
"I am tired of facing numerous compliance challenges and penalties because of the way our investigation reports are written. We make too many mistakes and the auditors know it."
"I wish I had these trainings digitally available anytime so that my employees can access them whenever they have doubts or need to refresh a topic. It would also be awesome for the onboarding process of newcomers to CAPA roles."
"We are wasting too much money on rework because the proper corrective actions were not taken, and impact analysis was not properly performed. My team does not have that much experience."
"We keep losing many good employees because we do not develop them in CAPA, and they lack motivation. We don't have time for training."
"Our production processes and deliveries are always getting impacted because the same unresolved quality issues keep arising and there is too much time wasted on the review and approvals of my team's investigation reports. The reports are always rejected."
"My team does not have the knowledge or skills for how to gather and verify evidence for an investigation report, much less to correctly assess the effectiveness of the CAPA Plans implemented. This is stressful".
Don't worry, I can help!
Ready to take the stress out of CAPA, Root Cause Analysis, Investigation Reports,
and lead a team that’s prepared for anything?
Let me help you build a confident, empowered and capable team that keeps your company compliant, solves problems faster and stays ahead of the game
in the regulated industry with custom digital courses.
Let’s work together to make CAPA simple and give your team the tools they need to:
Master the CAPA System
Understand the basics and fundamentals so the CAPA System works for you, not against you.
Find the Real Root Cause
Stop treating symptoms and solve the real problem the first time using a systematic and friendly approach.
Write Investigation Reports That Get Approved
Clear, effective reports that regulators and quality reviewers actually want to approve and do not delay your deliveries or impact customer satisfaction.
Ready to get started?
Free Resources
To level up your team's CAPA game and mindset to boost their confidence!
Investigate with Confidence: The Human Error Checklist You Need!
If you’re in a CAPA or Quality role and are tired of guessing what went wrong, missing the real cause, or dealing with recurring issues related to human errors… This checklist is for YOU.
E-Book Mindset Magic - How to Eliminate the Daily Overwhelm of CAPA, Root Cause Analysis and Writing Investigation Reports
Tired of dealing with the same quality issues over and over? It’s time for a mindset shift that will help you tackle problems like a CAPA pro and finally break the cycle! 💪
The CAPA Made Easy Blog
On THIS blog, you're not just diving into CAPA, investigation reports, and root cause analysis — you’re stepping into my journey, too.
You’ll find my five core pillars woven into everything I share:
✨ Simplifying CAPA Systems so they actually make your life easier.
🔍 Mastering Root Cause Analysis to fix issues for good (bye-bye repeat problems!).
✍️ Writing Investigation Reports That Shine —and make auditors & reviewers nod with approval.
💪 Building Confident and Compliant Teams who crush their goals.
🌟 And a sprinkle of Mindset and Motivation to keep you feeling unstoppable.
From Chaos to Clarity: Mastering Problem Definition for CAPA Success
Struggling to get clear answers during investigations? Learn how to master problem definition in CAPA with simple tips to save time, reduce frustration, and lead investigations confidently. Turn chaos... ...more
CAPA Tips
December 04, 2024•2 min read
From Overwhelmed to Confident: Thriving in Your New CAPA Role
This blog shares simple tips to build confidence, impress leaders, and thrive, even as a beginner. Learn how to embrace your potential and discover why you’re exactly where you’re meant to be. Start y... ...more
CAPA Tips
November 27, 2024•3 min read
You’re Not Just a CAPA Pro – You’re a Leader
In this blog, I remind you that being a CAPA professional isn’t just about investigations—it’s about leadership! Learn how to embrace your role as a problem-solver, trend-spotter, and systems improver... ...more
CAPA Tips
November 18, 2024•2 min read
TESTIMONIALS
Some love 💖words from clients and friends
Magda Silveira
Executive Director Quality, Olympus Corporation
I had the pleasure to work with Laisa in a project where we had developed a CAPA modules for beginners and she did an amazing job, and I recommend her to anyone that is looking for a seasoned training developer as she spotted on.
Jay Tyler
Recruitment Consultant, Acceler8 Talent
I've had the pleasure of working with Laisa and I would highly recommend her. She is extremely knowledgeable in her field of expertise, she is a very effective communicator, and she is truly passionate about what she does. Beyond her work, she is very kind and if given the chance to work with Laisa again, I wouldn't blink!
Franklin Allen
Director of Quality & Continuous Improvement at Gorbel Inc.
Laisa did an excellent presentation for us at ASQ Rochester late last year. She taught our community about corrective and preventive action (CAPA) and how it may be required as part of the quality management system, such as the Medical Devices and Pharmaceutical industries.
Her expertise shown through and our community looks forward to hearing from her on other dynamic topics. Laisa, thank you for sharing your talents with us!
More ways to boost your team's
capa empowerment & confidence
Join the private CAPA Confidence Club! Learn CAPA, root cause analysis, investigation report writing, connect with peers and build confidence to excel.
The new go-to podcast for quality professionals and industry leaders ready to unlock the power of simplicity and transform their approach to CAPA, Root Cause Analysis and Investigation Reports!
READY TO make capa simple and have an empowered team of capa pros?
Let's Start TODAY!
Sign up for a free, fun chat with me to learn how I can simplify CAPA, Root Cause Analysis and Investigation Reports and how my custom courses can make a difference for you and your team!