Competency Evidence

Some training assignments require trainees to submit evidence of competency beyond document review and quiz completion. Supervisors review and approve or reject submitted evidence.

Permissions

Action	Required Role
Submit evidence	Assigned trainee
View pending approvals	Designated supervisor
Approve training	Designated supervisor
Reject training	Designated supervisor

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Submit competency evidence

When a training assignment has the Requires Evidence flag, you must submit evidence before you can complete the training with an electronic signature.

1. Complete the document review and assessment steps of your training.
2. Select Complete Training with Signature.
3. In the Submit Training Evidence modal, enter a description in the Evidence Description field. Explain what the evidence demonstrates (for example, “Photos of completed equipment qualification” or “Signed competency checklist from supervisor”).
4. Select Click to upload files and choose one or more files from your computer.
5. Optionally, enter a caption for each uploaded file in the caption field below the file name.
6. To remove a file before submission, select the X button next to the file.
7. Select Submit Evidence.

Note

Both a description and at least one file are required. The Submit Evidence button stays disabled until both are provided.

After successful submission, the system automatically proceeds to the electronic signature step.

Supported file formats

Format	Examples
Images	JPG, PNG, GIF, BMP, WebP
Videos	MP4, MOV, AVI, WebM
Documents	PDF, DOC, DOCX

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Requiring supervisor sign-off on a one-off assignment

When creating a one-off training assignment (Training → Assign training → One-off assignment), check Require supervisor sign-off under Completion requirements and choose the supervisor who must review it. The trainee’s completed training then appears on that supervisor’s pending-approvals list below.

The trainee’s own signature is not enough to mark this record complete: until the assigned supervisor signs off (or rejects it), the training register and the trainee’s completion page show it as Pending supervisor sign-off, not Completed — it does not count toward training compliance statistics, and a document gated on this training will not auto-transition to Effective. Only the supervisor named on the assignment can provide the sign-off.

Review pending approvals (supervisors)

1. From Training, select Supervisor approval to open the Supervisor Approval - Competency Training page.

The page displays a table of pending approvals with the following columns:

Column	Description
User	Trainee’s name and email
Document	The training document title
Completed Date	When the trainee completed the training
Evidence	View Evidence button (if evidence was submitted) or “No evidence”
Actions	Approve and Reject buttons

View submitted evidence

2. In the row for the training you want to review, select View Evidence.
3. In the Evidence Review modal, review the trainee’s description and select Download to view the evidence file.
4. Close the modal to return to the approvals list.

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Approve training

1. In the row for the training you want to approve, select Approve.
2. In the verification code signature modal, click Get Verification Code to receive a 6-digit code via email.
3. Enter the 6-digit verification code.
4. Select Complete Training.

A success message confirms the approval, and the training is removed from the pending list.

Caution

OTP verification code confirmation is required for every approval action. This creates a legally binding electronic signature in compliance with 21 CFR Part 11. Review the evidence thoroughly before approving.

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Reject training

1. In the row for the training you want to reject, select Reject.
2. In the confirmation dialog, enter a reason explaining why the evidence is being rejected. A reason is required and is shown to the trainee.
3. Select Reject to confirm.

A success message confirms the rejection, and the training is removed from the pending-approvals list.

Caution

Only the assigned supervisor can reject a training assignment — the same requirement as approving it. Rejecting does not delete the training record: it moves to a Rejected status, retaining the rejection reason as part of the training record for audit purposes.

Resubmit rejected training (trainees)

If your supervisor rejects your submitted evidence, your training record shows a Rejected status with the supervisor’s reason.

1. From Training, select your rejected assignment’s row.
2. Review the Submission rejected notice and the reason given.
3. Select Resubmit training.

The training returns to an in-progress state so you can complete the document review, assessment, and evidence submission steps again and resubmit for supervisor approval.

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Practical example: submitting and approving hands-on evidence

Scenario: Lab technician Ana Rivera completed training on SOP-QC-010 (HPLC System Operation) and must submit evidence of a supervised equipment run before her training can be approved.

As the trainee (Ana):

1. After reviewing the SOP and completing the quiz, select Complete Training with Signature.
2. In the Submit Training Evidence modal, enter the description: Completed supervised HPLC analysis of reference standard RS-2026-04 on HPLC-03. Run included system suitability, sample injection sequence, and data review per SOP-QC-010 Section 6. Supervised by Dr. Chen on 5 March 2026.
3. Select Click to upload files and attach two files:
   • HPLC-03_system_suitability_20260305.pdf — caption: System suitability test results showing all parameters within acceptance criteria
   • competency_checklist_signed.pdf — caption: Signed competency checklist with supervisor verification
4. Select Submit Evidence. The system proceeds to the electronic signature step.

As the supervisor (Dr. Chen):

1. From Training, select Supervisor approval.
2. Find Ana Rivera’s record for SOP-QC-010 in the pending approvals table.
3. Select View Evidence, download both files, and verify the system suitability results meet acceptance criteria and the checklist is properly signed.
4. Close the evidence modal, then select Approve.
5. Click Get Verification Code, enter the 6-digit code sent to your email, and select Complete Training to create the electronic signature record.

Best practices

Tip

• For trainees: Provide specific, detailed descriptions. Instead of “Completed training,” write “Completed hands-on equipment qualification for HPLC system per SOP-QC-001. Photos show completed checklist and equipment readings.”
• For supervisors: Download and thoroughly review all evidence files before approving. Verify that the evidence demonstrates actual competency, not just completion.
• For administrators: Use the Requires Evidence flag judiciously — reserve it for training where document review alone is insufficient to demonstrate competency (for example, equipment operation, laboratory techniques, safety procedures).