Clarix
Modules

Training Records

Personnel qualification, training management, and compliance tracking

Training Records

Manage all personnel qualifications, training assignments, and regulatory compliance tracking.

Concepts

ConceptDescription
Training RequirementA defined training item mapped to roles (e.g., "SOP-001 must be read by all pharmacists")
Training AssignmentAn instance of a requirement assigned to a specific user with a due date
Competency AssessmentA practical skills evaluation (e.g., aseptic technique, garbing)
QualificationA time-limited credential (e.g., media fill, 6-month validity)

Training Lifecycle

Requirement Defined <Icon name="ArrowRight" size={12} /> Auto-Assigned to Roles <Icon name="ArrowRight" size={12} /> User Completes <Icon name="ArrowRight" size={12} /> Acknowledged (e-signed)

                                                              Document Updated <Icon name="ArrowRight" size={12} /> Re-Assignment

Qualification Types

TypeValidityRe-qualification
Media Fill6 monthsTwo consecutive passes required
Garbing12 monthsAnnual assessment
Aseptic Technique12 monthsAnnual practical + written
SOP TrainingUntil document updatedRe-read on new version
Equipment Operation12 monthsAnnual competency check

Business Rules

RuleDescription
TR1Users cannot access production modules until onboarding training complete
TR2Expired media fill qualification blocks batch assignment
TR3Document approval triggers auto re-training for all users trained on previous version
TR4Two consecutive media fill failures removed from sterile compounding until retrained
TR5Training records are immutable — new entries append, never modify

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