eQMS Foundations Course for Quality Teams

The eQMS Foundations Course from Akitra Academy provides a practical introduction to Electronic Quality Management Systems and the core processes behind modern quality operations. You’ll learn how document control, employee training, CAPA, nonconformances, change control, quality records, and audit readiness work together to create a connected and traceable quality system.

Through concise lessons, you’ll also explore key requirements including FDA 21 CFR Part 11, FDA QMSR, ISO 13485, ISO 9001, and EU MDR, along with quality metrics and continuous improvement. The course also introduces how automation and AI can improve workflows, traceability, quality monitoring, and audit readiness.

What You’ll Learn

By the end of this course, you will be able to:

• Understand the fundamentals of QMS and eQMS.
• Navigate key requirements including FDA 21 CFR Part 11, FDA QMSR, ISO 13485, ISO 9001, and EU MDR.
• Manage document control, approvals, versioning, training, and quality records.
• Understand CAPA, nonconformance, root cause analysis, and change control.
• Build end-to-end traceability across quality processes and records.
• Maintain audit trails and prepare evidence for audits and regulatory inspections.
• Track quality KPIs, identify trends, and drive continuous improvement.
• Apply risk-based thinking to quality management decisions.
• Understand how automation and AI can improve quality workflows, monitoring, and analysis.
• Build a connected, scalable, and continuously audit-ready quality system.

Who Should Take This Course?

This course is ideal for:

• Quality Managers and Quality Professionals
• Quality Assurance (QA) Teams
• Quality Control (QC) Professionals
• Regulatory Affairs Professionals
• Compliance and GRC Professionals
• Document Control Specialists
• CAPA and Quality Systems Owners
• Internal Auditors
• Operations and Manufacturing Professionals
• Medical Device Professionals
• Pharmaceutical and Life Sciences Teams
• Biotechnology Professionals
• Professionals working in regulated industries
• Anyone looking to understand modern eQMS fundamentals

No previous eQMS experience is required. A basic understanding of quality or compliance concepts can be helpful but is not necessary.