CAPA Remediation Services for QMS & FDA QSR
"We don’t just check boxes, we solve problems."
CAPA (Corrective and Preventive Action) is more than just a regulatory requirement. It's a powerful tool to strengthen your Quality Management System (QMS), prevent recurrence of issues, and drive operational excellence. We specialize in CAPA remediation that is rooted in real-world experience, not theory.
We’ve helped medical device companies resolve hundreds of CAPAs, from minor audit findings to full-blown remediation projects. Whether you are facing QMS audit nonconformances, struggling with CAPA documentation, or need full CAPA implementation support, we’re here to get you unstuck.
Our Approach: From Root Cause to Resolution
CAPA support services you can count on — practical, structured, and always hands-on.
We believe every nonconformity is an opportunity to improve. But only if the CAPA resolution is well-managed, feasible, and grounded in reality.
Key CAPA Services:
- CAPA remediation for ISO 13485 & FDA 21 CFR Part 820
- CAPA under EU MDR 2017/745
- Audit finding remediation
- Corrective and preventive action training
- CAPA process improvement
- CAPA investigation support
- Root cause analysis and planning
- Full CAPA resolution support
- Help with CAPA documentation and effectiveness evaluation
QMS isn't about avoiding findings, it's about addressing them the right way with the right CAPA process.
Nonconformities mainly arise from:
- Internal or external audits
- Management reviews
- KPI trends
- Customer complaints
- Product performance issues
And that’s normal.
The real value lies in how you address them. We bring structure and clarity to your CAPA process, so you stop firefighting and start fixing.
Practical Root Cause Analysis First
We use established tools like 5 Whys, Ishikawa diagrams, or Fault Tree Analysis, but never blindly. Our strength lies in logical thinking, domain knowledge, and many years of hands-on QMS experience.
Common Root Causes We Encounter:
- ❌ Unclear processes with open ends and undefined responsibilities
- ❌ Fragmented quality systems with poor cross-functional linkage
- ❌ Overengineered procedures that are compliant but unusable
- ❌ Manual work processes leading to frequent human errors
- ❌ Ineffective training systems that don’t build understanding
- ❌ Processes not feasible for your organization’s scale or complexity
Our Approach to CAPA: Corrective and Preventive Actions That Strengthen Your QMS
Correction: Short-Term Control Before Long-Term Action
"Fix the problem today, but build a better system for tomorrow."
Correction addresses the symptom by fixing the issue in the short term. This step restores control quickly but does not prevent recurrence.
We help you stabilize operations immediately, but our focus is on building Corrective and Preventive Actions that ensure the problem doesn’t come back.
Corrective Action (CA): From Symptom to System
Correction fixes the symptom. Corrective Action cures the cause.While correction addresses the immediate issue, it doesn’t prevent it from happening again. Corrective Action goes deeper; it's about identifying and eliminating the root cause to create long-term, sustainable improvement.
Examples of Corrective Actions That Go Beyond Compliance
Corrective actions shouldn't just satisfy audit checkboxes. They can resolve deeper structural issues and bring lasting improvements across your organization. We will help you with:
- ✔️ Clear processes that reduce staff errors and improve operational excellence
- ✔️ Defining interdepartmental interfaces, improving communication and collaboration
- ✔️ Automating QMS tasks that save time and reduce human error
Preventive Action (PA): Proactive Risk Reduction
Anticipate tomorrow’s challenges, strengthen your system today.
Preventive Action isn’t about fixing what’s already broken, it’s about making sure it never breaks in the first place. By proactively identifying risks, vulnerabilities, and inefficiencies, Preventive Actions help you optimize processes, strengthen resilience, and protect compliance before issues arise.
We focus on digitalization, automation, and optimization to help you build a smarter Quality Management System (QMS) that continuously improves.
Examples of Preventive Actions That Drive Continuous Improvement
Preventive actions can go beyond traditional compliance and actively create stronger, leaner systems. We help you with:
- ✔️ Proactive risk assessmentsfor new and evolving processes
- ✔️ Automation of routine QMS tasks to reduce human error
- ✔️ Optimization of digital workflows for faster, more reliable results
- ✔️ Targeted training programs to prevent recurring mistakes
- ✔️ Data-driven insights to anticipate and eliminate future risks
What Sets Us Apart
💡 Real-World Experience
We have built many QMS systems from the ground up. We understand the pressure of maintaining compliance while keeping your business operational.
🛠️ Hands-On Problem Solving
We dive in with your team, not from a distance. You won’t get a PowerPoint; you’ll get real solutions.
📈 Smart, Feasible Fixes
Our fixes are not just regulatory-compliant; they make sense for your people, processes, and whole organization.
🤝 You Can Rely On Us
We have helped companies just like yours that were stuck, overwhelmed, or drowning in open CAPAs. Let us do the same for you.
When Your CAPA System Itself Is the Problem
Many organizations aren’t just struggling with CAPAs; they’re struggling with how CAPAs are handled in their organization.
Therefore
- We often start with a redesign of your CAPA process.
- Build a system that’s efficient, not burdensome
- Then we align with the team on realistic CAPA objectives and action plans.
- Clarify ownership and accountability.
- Tackle each nonconformity with this new clarity
The result? CAPA remediation projects that move faster, smoother, and deliver long-term value.
FDA Compliance Remediation and 483 Response Support
Corrective Actions That Withstand FDA Regulatory Scrutiny
When facing a Form FDA 483, warning letter, or an FDA compliance audit, your CAPA process must go beyond documentation; it must demonstrate genuine control, accountability, and systemic improvement.
Our FDA 483 & Compliance Support Services
We support FDA-regulated companies through:
- 483 response planning and CAPA remediation
- System-wide gap assessments and root cause analysis
- Clear alignment of each finding with corrective and preventive actions
- Documentation of effectiveness checks, training, and management commitment
Ensure your QMS aligns with FDA Quality System Regulation.
Rebuilding Trust and Compliance After FDA Findings
Whether you're navigating FDA QSR (21 CFR 820) requirements or rebuilding a quality system after enforcement action, we help you:
- Identify, understand and address systemic quality issues
- Avoid vague commitments and fix-the-symptom responses
- Build a compliance roadmap aligned with FDA expectations
- Prepare clear, structured responses that hold up in audits
Expert guidance to bring your device to market with confidence.
Frequently Asked Questions (FAQ)
Q: What is root cause analysis in the CAPA process?
A: Root cause analysis is the structured method used to identify the underlying reason(s) for a nonconformity or quality issue. In the CAPA process, it's essential because it ensures that the corrective action targets the real cause of the problem, not just its symptoms.
Q: What is the action plan required by Notified Bodies after an audit?
A: Following an audit with findings, Notified Bodies typically request a formal CAPA plan. This includes:
- A clear description of each nonconformity
- Documented root cause analysis
- Defined corrections and corrective actions
- Preventive actions (where applicable)
- A timeline and responsible persons
- A plan for effectiveness evaluation
We help you create a complete and credible action plan that satisfies the Notified Body and addresses the real issue.
Q: What is the difference between CAPA based on ISO 13485, 21 CFR 820, and EU MDR 2017/745?
A: While all three require robust CAPA processes, there are subtle but important differences:
- ISO 13485 and FDA 21 CFR Part 820 are largely aligned. Both require a structured, risk-based CAPA process integrated into the quality system. The main difference lies in regulatory oversight, but their intent is nearly identical.
- EU MDR 2017/745 expands CAPA to feed into broader compliance elements like clinical evaluation and post-market surveillance.
We ensure your CAPA process satisfies all three — without duplication or inefficiency.
Q: What is effectiveness evaluation?
A: Effectiveness evaluation is the final and critical step in the CAPA process. It answers the question:
“Did the corrective action actually solve the problem and prevent it from recurring?”
This includes defining measurable criteria upfront and verifying after implementation whether those criteria were met. We help you set clear, realistic metrics that make this step auditable and meaningful.
Q: What is correction in the CAPA process?
A: Correction is the immediate action taken to contain or eliminate the detected problem. It's about fixing what went wrong, for example, reworking a batch, updating a document, or correcting a label.
It’s a necessary first step, but by itself, correction does not prevent recurrence. That’s where corrective action comes in.
Q: What is Corrective Action?
A: Corrective action is the step taken after root cause analysis to eliminate the cause of the nonconformity, not just the effect. It may involve changing procedures, responsibilities, training, or system architecture. The goal is to ensure the problem won’t happen again under the same circumstances.
Q: What is Preventive Action?
A: Preventive action involves identifying potential issues before they occur and addressing them proactively. While ISO 13485 and FDA 21 CFR 820 traditionally separate preventive action, newer approaches often integrate it into risk management and continuous improvement. Under EU MDR, post-market data also feeds into preventive action planning.