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Summary

Training Log provides systematic documentation of individual employee training activities, ensuring comprehensive records of competency development and regulatory compliance for each team member. This essential Quality Management System (QMS) record tracks training completion, demonstrates personnel qualifications, and supports regulatory audit requirements across all functional roles within your medical device organization.

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Why is Training Log important?

Training logs serve as critical evidence that your organization maintains competent personnel capable of performing assigned tasks that affect product quality and regulatory compliance. Without documented training records, you cannot demonstrate to auditors or regulatory authorities that employees possess required competencies or understand their quality responsibilities. Regulatory compliance mandates systematic training documentation. FDA Quality System Regulation (21 CFR 820.25) and ISO 13485:2016 (Section 6.2) require organizations to establish procedures for identifying training needs and ensuring personnel competency. Training logs provide objective evidence that these requirements are systematically fulfilled for each employee. The documentation transforms training from informal knowledge transfer into systematic competency assurance. Well-maintained training logs support performance evaluations, identify additional training needs, and provide traceability when investigating quality issues or non-conformities that may relate to personnel competency gaps.

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Regulatory Context

  • FDA
  • MDR
Under 21 CFR Part 820.25 (Personnel):
  • Organizations must establish procedures for identifying training needs and ensuring personnel competency
  • Training must be documented with records demonstrating completion and understanding
  • Personnel performing verification and validation activities must be aware of defects and errors they may encounter
  • Management representative requires documented authority and competency over quality system requirements
Special attention required for:
  • Design control personnel training documentation (21 CFR 820.30)
  • Software validation training requirements for software medical devices
  • Corrective and Preventive Action (CAPA) training when process improvements are implemented
  • Management review participation requiring quality system understanding

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Guide

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Individual Training Log Structure

Create comprehensive individual training records for each employee documenting their complete training history. Include employee identification with name, start date, functional group, and supervisor information to establish training accountability and management oversight. Document training systematically using structured tables capturing training name, initial versus continuous training designation, training delivery method, due dates, completion dates, learning summaries, and participant initials. Ensure traceability between training requirements and individual completion records. Maintain current training status by regularly updating records when new SOPs are released, existing procedures are revised, or additional competency development occurs. Track training effectiveness through learning summaries that demonstrate understanding rather than mere attendance.

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Training Content Organization

Align training requirements with individual functional roles and responsibilities. Quality team members typically require comprehensive training across all QMS procedures, while software team members focus on development-related SOPs and technical procedures. Management personnel need training emphasizing leadership responsibilities and regulatory oversight. Include all relevant SOPs in training logs based on employee responsibilities. Document both initial training completed during onboarding and continuous training required for SOP updates, role changes, or competency improvements. Specify training delivery methods including online review, in-person sessions, mentoring, or external courses. Establish training timelines with realistic due dates considering employee workload and training complexity. Monitor completion status systematically and follow up on overdue training to maintain current competency levels across your organization.

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Training Verification and Documentation

Require documented confirmation of training completion through employee initials, signatures, or electronic acknowledgment. Capture learning summaries where employees briefly describe key takeaways or how training applies to their work responsibilities. This demonstrates understanding rather than passive completion. Link training records to specific document versions when training covers SOPs or procedures. This maintains traceability when procedures are updated and ensures employees were trained on current requirements. Document training delivery methods to support training effectiveness assessments. Establish training record retention following your document control procedures and regulatory requirements. Maintain training logs for the device lifetime or as specified by applicable regulations, typically not less than two years from device market release.

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Ongoing Training Management

Monitor training program effectiveness through management review processes and quality metrics. Assess whether training translates into improved job performance, reduced errors, or enhanced regulatory compliance. Identify training gaps through performance evaluations, audit findings, or non-conformity investigations. Update training requirements when new regulations emerge, SOPs are revised, or organizational roles change. Communicate training updates clearly to affected employees and establish completion deadlines that ensure competency before new requirements become effective. Integrate training management with your human resources processes including performance evaluations, career development planning, and succession management. Use training records to support promotion decisions, role assignments, and competency-based task allocation.

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Training Record Integration

Connect training logs with your broader quality management system including management review, internal audits, and corrective action processes. Reference training records when investigating quality issues to determine if competency gaps contributed to non-conformities. Support external audits by maintaining readily accessible training documentation that demonstrates systematic competency management. Prepare training summaries showing completion rates, overdue training, and training effectiveness metrics for management and auditor review. Coordinate training documentation with supplier management when external personnel perform work affecting product quality. Ensure contractor and consultant training is documented and verified according to your training procedures.

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Example

Scenario: You hire a new software engineer, Sarah Chen, who joins your development team responsible for implementing cybersecurity features in your medical device software. You need to establish and maintain her training log to ensure regulatory compliance and competency development.

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Initial Training Log Setup

You create Sarah’s individual training log documenting her name, start date of March 15, 2024, functional group as Software/Product Development, and supervisor as the Lead Software Engineer. Her initial training plan includes all SOPs relevant to software development roles.

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Required Training Documentation

Sarah’s training log includes initial training on Quality Manual, SOP Design Control, SOP Software Development, SOP Risk Management, SOP Cybersecurity, SOP Document and Record Control, SOP Change Management, and SOP Computer System Validation. Each entry specifies “Initial Training” type and “Online review” delivery method with due dates within 30 days of start.

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Training Completion Process

Sarah completes SOP Cybersecurity training on March 22, 2024, documenting her learning summary: “Understood cybersecurity risk assessment procedures, secure coding practices, and vulnerability management requirements for medical device software. Will apply threat modeling techniques in current project development.” She initials the completion record.

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Ongoing Training Management

When your organization updates the SOP Software Development in June 2024, Sarah receives continuous training on the revised procedure. Her training log documents completion on June 10, 2024, with learning summary focusing on new automated testing requirements and documentation templates introduced in the updated SOP.

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Training Record Maintenance

Sarah’s supervisor regularly reviews her training log during quarterly performance discussions, identifying additional training needs based on project assignments and career development goals. The training log serves as evidence during internal audits and management reviews of training program effectiveness.

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Q&A

Include all SOPs relevant to the employee’s functional role, quality management system training, job-specific procedures, safety training, and any specialized competency development. For software team members, focus on development-related SOPs. For quality team members, include comprehensive QMS procedures. Document both initial onboarding training and continuous training for updates.
Align SOP training with job responsibilities and quality impact. Quality team members typically need training on all SOPs. Software team members require development, validation, and cybersecurity-related SOPs. Management needs SOPs related to oversight responsibilities. Consider which procedures the employee will implement or be affected by in their daily work.
Document training name/SOP version, completion date, training delivery method, learning summary demonstrating understanding, and employee confirmation through initials or signature. Learning summaries should show comprehension rather than mere attendance. Link training to specific document versions for traceability when procedures are updated.
Update training logs immediately when employees complete training activities. Review logs during employee performance evaluations, management reviews, and when new training requirements emerge. Establish regular monitoring for overdue training and ensure logs are current before internal audits or regulatory inspections.
Add continuous training entries to affected employees’ training logs specifying the updated SOP version and establishing completion deadlines before the new procedure becomes effective. Document the training delivery method and require learning summaries focusing on changes introduced in the updated procedure.
Training logs provide objective evidence that personnel are competent to perform assigned tasks affecting product quality. They demonstrate systematic training management, competency verification, and compliance with regulatory requirements for personnel qualifications. Auditors review training logs to verify that employees understand their quality responsibilities.
Document specific training methods such as online review, in-person sessions, mentoring, external courses, webinars, self-study materials, or practical demonstrations. Different training methods may be appropriate for different learning objectives. Include trainer information when applicable and training duration for complex topics.
Apply the same training documentation requirements to temporary employees and contractors who perform work affecting product quality. Establish training requirements in contracts and ensure completion before beginning work. Maintain training records according to your document retention procedures and consider training transfer when contracts end.
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