Medical Device Quality Management: ISO 13485
Build, run and defend an ISO 13485 quality system, from scope and design controls to suppliers, CAPA and audits
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ALCOA+ Principles for Quality, Laboratory & Regulated Workplaces
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Build practical skills in Good Documentation Practices and data integrity for quality, laboratory and regulated workplaces. Learn how to create clear, accurate and traceable records; apply ALCOA and ALCOA+ principles; make entries and corrections correctly; control SOPs, forms, logbooks and document versions; recognize paper and electronic data-integrity risks; and support audit-ready documentation. Learning is reinforced through four interactive activities, two knowledge-check quizzes, one practical branching scenario, a final assessment, and an eight-resource downloadable GDP & Data Integrity toolkit.
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No formal prerequisites. Basic familiarity with quality, laboratory, healthcare, pharmaceutical, food, manufacturing, medical-device, biotechnology or other regulated workplace processes is helpful but not required.
Includes 2 knowledge-check quizzes, 4 interactive activities, 1 practical branching scenario and a 25-question final assessment. Final assessment pass mark: 70%. SkillCert attempts are unlimited. The certificate is issued only after all mandatory learning items are completed and the final assessment is passed.
Earn the Innoryx SkillCert in Good Documentation Practices & Data Integrity Essentials after completing all mandatory learning items and successfully passing the final assessment. The certificate demonstrates practical understanding of GDP, ALCOA+, document control and data-integrity principles for quality and regulated workplaces.
Certificates can be verified onlineRelevant for professionals working in quality assurance, quality control, laboratories, pharmaceuticals, biotechnology, healthcare, medical devices, food, manufacturing, document control, compliance, auditing, operations and other regulated or quality-focused environments.
Refund eligibility for course fees, books and third-party registrations is explained in our Refund & Cancellation Policy. Please review it before enrolling, including the Highfield and awarding-body terms where applicable.
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Build, run and defend an ISO 13485 quality system, from scope and design controls to suppliers, CAPA and audits
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