# Training Management ## Overview Ensuring that every team member is properly trained—and that training records are current, complete, and audit-ready—is a critical requirement in regulated laboratory and manufacturing environments. The [Training Management](https://www.labii.com/products/training-management) application built on Labii provides a centralized platform for managing the full training lifecycle: from defining training programs and certifications to assigning training to personnel, tracking completion, and maintaining verifiable records. By organizing training data across three dedicated tables—training records, training certifications, and training protocols—Labii enables quality, compliance, and operations teams to systematically manage employee competency requirements, enforce training-before-task policies, and demonstrate compliance during internal audits, regulatory inspections, and accreditation reviews. The application supports GMP, GLP, ISO 9001, ISO 13485, and other quality frameworks that mandate documented training and competency programs. {% hint style="info" %} This application is ideal for organizations required to maintain training records under FDA 21 CFR Part 211, ISO 9001, ISO 13485, GLP regulations, CAP/CLIA laboratory accreditation standards, or any quality system where personnel qualification must be documented. {% endhint %} ## Use Cases ### Pharmaceutical and Biotech GMP Training * Assign GMP training requirements to manufacturing and quality personnel * Track completion of SOP training tied to job roles and responsibilities * Manage retraining triggered by SOP revisions or quality events * Document training-before-task compliance for regulated manufacturing activities * Maintain training matrices linking personnel to required procedures ### Medical Device Quality Systems * Manage initial and ongoing training per ISO 13485 requirements * Track training on design controls, risk management, and post-market surveillance procedures * Document competency assessments for critical process operators * Support notified body audits with organized, searchable training records * Link training completions to the document control system for SOP-tied training ### Clinical and Diagnostic Laboratories * Manage initial competency assessment programs for new laboratory personnel * Track annual competency re-evaluations per CLIA and CAP requirements * Document training on new test methods, instruments, and analytical procedures * Maintain records of proficiency testing participation and results * Support ISO 15189 accreditation with comprehensive personnel training files ### Academic and Research Institutions * Onboard new researchers and graduate students with required safety and compliance training * Track completion of institutional training requirements (animal use, biosafety, radiation safety) * Document protocol-specific training for personnel conducting regulated research * Manage training renewals and certification expirations for laboratory personnel * Maintain GLP training records for studies submitted to regulatory agencies ### Contract Research Organizations (CROs) * Manage study-specific training assignments for personnel working on client studies * Demonstrate personnel qualification to sponsors during study audits * Track training on client-specific SOPs and analytical methods * Document cross-training and backup personnel qualifications * Maintain training records across multiple concurrent studies and clients ## Getting Started {% stepper %} {% step %} Navigate to **Settings → Applications** from the main menu {% endstep %} {% step %} Click **Add application** and select **Add from a template** {% endstep %} {% step %} Choose **Training Management** from the template list {% hint style="warning" %} If Training Management is not listed, it may already be installed. Check the side menu for the training tables. {% endhint %} {% endstep %} {% step %} Wait for installation to complete. The system will automatically create three tables: * **training** — Training assignment and completion records * **training\_certification** — Certification and qualification records for personnel * **eln\_protocol** — Training protocols and instructional content {% endstep %} {% step %} Begin by creating training protocols in the **eln\_protocol** table, then set up certifications in **training\_certification**, and finally assign training to personnel using the **training** table {% endstep %} {% endstepper %} ## Application Structure ### Training Table The **training** table is the operational core of the application, capturing individual training assignments, delivery, and completion status for each person. **Purpose**: Record who was trained, on what topic, when, by whom, and whether they passed or require retraining **Typical Use**: SOP training assignments, onboarding training records, retraining events following procedure changes or quality incidents, training-before-task documentation *** ### Training Certification Table The **training\_certification** table manages formal certifications and qualifications that personnel must hold to perform specific roles or tasks. **Purpose**: Define certification requirements, track personnel certification status, expiration dates, and renewal schedules **Typical Use**: Role-based qualification records, equipment operator certifications, method validation certifications, annual competency re-evaluations, regulatory-required certifications (e.g., GMP qualifications) *** ### ELN Protocol Table The **eln\_protocol** table stores the training protocols, instructional content, and assessment materials used to deliver and evaluate training. **Purpose**: Maintain a controlled library of training materials, quizzes, and protocols that serve as the content basis for training assignments **Typical Use**: SOP-based training protocols, safety training materials, equipment operation guides, competency assessment checklists, onboarding curricula ## Creating a Training Protocol Before assigning training, build the training content in the **eln\_protocol** table. {% stepper %} {% step %} Navigate to the **eln\_protocol** table from the side menu {% endstep %} {% step %} Click **+ Add** to create a new training protocol {% endstep %} {% step %} Enter the protocol details: * **Name**: Clear, descriptive title (e.g., "GMP Fundamentals – Initial Training" or "Pipetting Competency Assessment") * **Protocol type**: Training protocol, competency assessment, safety training, onboarding module, etc. * **Version**: Current version number * **Owner**: Responsible author or department * **Status**: Drafting, Pending Review, Approved, or Archived {% endstep %} {% step %} Add training content using the **Steps** section widget to create structured, step-by-step instructional content, or use the **Steps (Text)** section for rich text narrative content {% endstep %} {% step %} Attach reference documents, presentations, or supporting files using the **Files** section {% endstep %} {% step %} Route the protocol for review and approval using the **Signature** widget to obtain electronic sign-off from the responsible reviewer and approver before using the protocol for training {% endstep %} {% endstepper %} {% hint style="info" %} Linking training assignments to approved protocol records creates an auditable chain showing that training was conducted using controlled, approved content. {% endhint %} ## Assigning and Recording Training {% stepper %} {% step %} Navigate to the **training** table from the side menu {% endstep %} {% step %} Click **+ Add** to create a new training record {% endstep %} {% step %} Fill in the training assignment details: * **Name**: Descriptive title of the training event (e.g., "SOP-0042 Training – J. Smith") * **Trainee**: The individual being trained * **Training protocol**: Link to the relevant **eln\_protocol** record * **Trainer / Assessor**: The qualified person delivering or evaluating the training * **Assigned date**: When the training was assigned * **Due date**: Deadline for completion {% endstep %} {% step %} After the training is delivered, update the record with completion details: * **Completion date**: When training was completed * **Training method**: Classroom, read-and-understand, hands-on demonstration, e-learning, etc. * **Assessment result**: Pass, Fail, or Requires Retraining * **Notes**: Any relevant observations from the trainer or assessor {% endstep %} {% step %} Capture the trainee's acknowledgment and the trainer's sign-off using the **Signature** widget to create an electronically signed training record {% endstep %} {% step %} If the trainee did not pass, document the outcome and create a new training record for the retraining event {% endstep %} {% endstepper %} {% hint style="warning" %} Training records should be completed and signed as close to the training event as possible. Back-dating or reconstructing training records is a significant compliance risk and a common audit finding. {% endhint %} ## Managing Certifications {% stepper %} {% step %} Navigate to the **training\_certification** table from the side menu {% endstep %} {% step %} Click **+ Add** to create a new certification record {% endstep %} {% step %} Define the certification: * **Name**: Certification title (e.g., "GMP Operator Qualification – Sterile Fill" or "HPLC Operator Certification") * **Personnel**: The individual holding or pursuing this certification * **Certification type**: Initial qualification, annual re-certification, role-based qualification, etc. * **Required training**: Link to the **training** records that fulfill the requirements for this certification * **Issue date**: When the certification was granted * **Expiration date**: When the certification expires and renewal is required * **Status**: Active, Expired, Suspended, or Revoked {% endstep %} {% step %} Attach the certification documentation, assessment results, or qualification reports using the **Files** section {% endstep %} {% step %} Obtain electronic signatures from the certifying authority (e.g., department manager, quality manager) using the **Signature** widget {% endstep %} {% step %} Set up notifications or calendar reminders to alert the relevant manager before the certification expiration date to initiate timely renewals {% endstep %} {% endstepper %} ## Advanced Features ### Training Matrix and Compliance Reporting Use Labii's filtering and reporting capabilities to build training matrices and compliance dashboards: * Filter the **training** table by trainee, protocol, or status to view training completion status across a team * Generate lists of overdue or expiring training assignments * Use the dashboard to visualize certification expiration timelines and training completion rates by department {% hint style="info" %} Create saved table views filtered by "Status = Incomplete" or "Due Date < Today" to quickly identify outstanding training obligations during audit preparation. {% endhint %} ### Automated Training Triggers from Document Changes When an SOP or procedure is revised and re-approved in the QMS Document table, use Labii's notification and workflow features to: * Alert the training coordinator that a document revision requires re-training of affected personnel * Create new training records linked to the updated protocol version * Track completion of revision-triggered retraining before personnel resume the related task ### Role-Based Training Requirements Use the **training\_certification** table to define role-based qualification requirements. Personnel moving into new roles can be assigned a structured set of certifications, with each certification linking to the specific training records required before the person is considered qualified for that role. ### Linking Training to Quality Events Connect training records to the QMS application to demonstrate corrective actions: * When a CAPA identifies inadequate training as a root cause, link the resulting training records to the CAPA record as implementation evidence * Reference training completions in Non-Conformance records to document that affected personnel have been retrained following a quality event ## Troubleshooting ### Issue: Training record signature is not capturing both trainee and trainer sign-off **Symptoms**: The Signature widget only shows one signature slot, or one party's signature is not appearing **Solution**: {% stepper %} {% step %} Confirm that the Signature widget in the **training** table is configured to capture multiple signatures (trainee and trainer). Contact your Labii administrator to add additional signature roles if needed {% endstep %} {% step %} Ensure both the trainee and trainer have active Labii accounts with access to the project containing the training record {% endstep %} {% step %} Share the record link directly with the trainer or trainee so they can locate and sign the record from their own account {% endstep %} {% endstepper %} ### Issue: Cannot find a training protocol to link to a new training record **Symptoms**: Searching the protocol link field returns no results or does not show the expected protocol **Solution**: {% stepper %} {% step %} Verify the **eln\_protocol** record is saved and its status is not **Archived** — archived records may be excluded from link search results {% endstep %} {% step %} Confirm you have access to the project that contains the protocol record. Cross-project linking requires appropriate permissions {% endstep %} {% step %} Try searching by the exact protocol name or a portion of it. If the record still does not appear, ask your administrator to check the table's link field configuration {% endstep %} {% endstepper %} ### Issue: Certification expiration dates are not triggering notifications **Symptoms**: Personnel or managers are not receiving alerts about upcoming certification renewals **Solution**: {% stepper %} {% step %} Check that notifications are enabled for the **training\_certification** table in **Settings → Notifications** {% endstep %} {% step %} Verify that the expiration date column is correctly configured and populated on the certification records that should trigger alerts {% endstep %} {% step %} Confirm that the relevant users have not muted or disabled Labii email notifications in their account preferences {% endstep %} {% endstepper %} --- # Agent Instructions: Querying This Documentation If you need additional information that is not directly available in this page, you can query the documentation dynamically by asking a question. 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