Frequently Asked Questions
What is involved in building a Quality Management System (QMS) from scratch?
Building a QMS from the ground up involves defining core quality processes (such as CAPA, Change Control, and Document Management), aligning with regulatory requirements (e.g., FDA, EMA, Health Canada), and ensuring scalability as your organization grows. At Retzlaff Consulting Inc., we help clients establish robust QMS foundations that support compliance, operational efficiency, and inspection readiness from Day 1.
How do you approach QMS transformation for companies with outdated or fragmented systems?
QMS transformation means modernizing your quality processes, improving digital capabilities, and aligning your system with current regulatory expectations. We lead projects that upgrade platforms (like Veeva or MasterControl), streamline workflows, and re-train teams for seamless adoption — all while maintaining GxP compliance and minimizing disruption.
What does QMS remediation mean, and when is it needed?
QMS remediation is the process of addressing compliance gaps after regulatory findings such as FDA 483s, EMA deficiency letters, or third-party audits. We conduct root cause analysis (RCA), develop CAPAs, and help redesign deficient quality processes — ensuring your QMS meets global regulatory expectations and restores stakeholder confidence
Can AI be used in a GxP-regulated environment?
Yes, AI can be used in GxP environments, but it must be deployed carefully. Retzlaff Consulting Inc. helps companies create governance frameworks, develop SOPs for responsible AI use, and ensure traceability, data integrity, and explainability — all critical for compliance with FDA and EMA expectations for AI systems.
How can AI be integrated into a QMS?
AI can enhance QMS performance through intelligent automation, predictive quality metrics, and smart document management. We advise on AI system validation, define quality controls, and benchmark your QMS against industry-leading AI applications — all within a compliant, risk-managed framework.
What QMS software platforms do you support?
We support implementation, optimization, and upgrades of major QMS platforms including Veeva Vault QMS and MasterControl and others. Whether you’re deploying a new system or optimizing existing workflows, we act as implementation leads, process experts, or project managers to ensure a smooth rollout that aligns with your compliance strategy.
Do you provide project-based or ongoing QA support?
We offer both. Our fractional QA support model gives you flexible access to senior QA expertise without the need for full-time hires. Whether you need interim QA leadership, SOP development, or audit prep, we can scale support to meet your operational and compliance needs.