CAPA Remediation Services for QMS & FDA QSR
We don’t just check boxes, we solve problems.
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
- Internal or external audits
- Management reviews
- KPI trends
- Customer complaints
- Product performance issues
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.
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 ImprovementPreventive 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 ExperienceWe have built many QMS systems from the ground up. We understand the pressure of maintaining compliance while keeping your business operational.🛠️ Hands-On Problem SolvingWe dive in with your team, not from a distance. You won’t get a PowerPoint; you’ll get real solutions.📈 Smart, Feasible FixesOur fixes are not just regulatory-compliant; they make sense for your people, processes, and whole organization.🤝 You Can Rely On UsWe 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
FDA Compliance Remediation and 483 Response Support
Corrective Actions That Withstand FDA Regulatory ScrutinyWhen 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
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
Frequently Asked Questions (FAQ)
Answer:
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.
Testimonials | Our Expertise in MedTech
Temedica
Vaclav did support our journey to become ISO 13485 certified with relentless work put into great processes, great communication and detailed and to the point conversations with the teams, individual members - but also our external auditors. He was of great support to move our QMS to the next level. He was the key person behind the move away from paper / scan based documents towards a digital setup.If you are in need for a structured person with great communication skills, a good understanding of the regulatory environment, I can only recommend to reach out to Vaclav. Lucky you if he's not booked ;-) Besides all the success he's an enjoyable and humble character. Great experience to having worked with him.
Börm Bruckmeier Verlag
Chief Content Officer
Vaclav was for our company an immense help in the process of getting ISO 13485 certified. He set up lots of QMS relevant documents, implemented a project management system in our company to support the sprints, the ticketing system and the overall documentation and gave always valuable input for all questions which arised in the long certification process. Vaclav is a very reliable, friendly person with excellent knowledge in medical, technical and regulatory fields.I liked his humour a lot, especially in tensed situations he was able to smooth out waves of stress.His structured way of working and his communications skills helped a lot to move ahead with all involved stakeholders - no matter if international programming team, auditors or clients.I would love to work with him again and envy anyone who will - lucky you!
