Test Drive: Sample Management

Part 2: Sample Release and Endotoxin Testing

Part 1: Navigate to Projects and Create a New Experiment

  1. From the Home screen, click the Projects module icon.

  2. On the Projects list page, locate the desired project (e.g., Test) and click + Experiments on the right side of that project row.

  3. In the New Experiment dialog (Step 1 — Define Experiment), confirm the Project is set correctly (e.g., "Test").

  4. Under the workflow type selector, choose Workflow Chain (radio button).

  5. In the Workflow Chain dropdown, select the appropriate chain (e.g., Endotoxin Testing).

  6. In the Version dropdown, select the desired version (e.g., 1.5 (04/20/2026)).

  7. Enter a Name for the experiment (e.g., CW 22 Apr 2026).

  8. Leave the plan fields (General Plan, Specification Plan, Sample Plan, BOM Plan) at Default Plan unless otherwise required.

  9. Click Next to proceed to Step 2.

Part 2: Select Start Node for the Workflow Chain

  1. On Step 2 — Select Start Node for WFC, review the workflow diagram showing the chain (e.g., "Endotoxin Testing" → "Generate CoT - Endotoxin").

  2. Verify the correct start node is highlighted (the Default Start Node is pre-selected). Click Next.

Part 3: Add Entities to the Experiment

  1. On Step 3 — Add Entities, click the Use Existing Entities tab.

  2. In the Entity Filters panel on the left, set the Entity Type filter to Endotoxin and click Search (or the filter updates automatically).

  3. From the results table, check the checkbox next to the desired entity (e.g., ESP000058).

  4. Click Next to proceed to Step 4.

Part 4: Review & Save the Experiment

  1. On Step 4 — Review & Save, verify the Experiment Details summary (Project, Workflow Chain, Version, Name, and entity count are all correct).

  2. Confirm the entity (e.g., ESP000058) appears in the entities table.

  3. Click Save & Submit to create the experiment and submit it to the lab.



Part 5: Open the Worksheet in LIMS

  1. Navigate to the LIMS module from the Home screen or top navigation.

  2. On the LIMS worksheet list, locate the newly created worksheet (e.g., CW 22 Apr 2026) and click it to open.

Part 6: Complete Protocol 1 — QC Start

  1. On the worksheet (Protocol 1 of 4 — QC Start), review the Shared Process Data section and confirm Training Status Verified is checked.

  2. In the sample property table, locate the Scan to Confirm Sample field for entity ESP000058.

  3. Click into the Scan to Confirm Sample field. A barcode dialog will open on the right showing the entity's QR code.

  4. Scan or manually enter the barcode value (ESP000058) into the scan field to confirm the sample.

  5. Close the barcode dialog by clicking Done.

  6. Check the Complete checkbox for the sample row, then click Save and Continue to advance to the next protocol.

Part 7: Complete Protocol 2 — Endotoxin: Reagents & Supplies

  1. On Protocol 2 of 4 — Endotoxin: Reagents & Supplies, fill in the Date Endotoxin Test Initiated field (e.g., 22Apr2026).

  2. For each required reagent/supply column (PTS Cartridges, Microcentrifuge Tube, LAL Reagent Grade Water, 1000 µL Pipette Tips, 200 µL Pipette Tips), click the cell and use the Item Filters search dialog to locate and select the correct inventory item (e.g., MDA-1920, MDA-10193, MDA-29294, MDA-19393).

  3. In the Item Filters dialog, search by name or tag and select the appropriate verified item, then click Submit.

  4. Once all reagents are assigned, check All applicable information entered and Complete, then click Save and Continue.

Part 8: Complete Protocol 3 — Endotoxin: Equipment

  1. On Protocol 3 of 4 — Endotoxin: Equipment, use the Resource Filters search dialog to assign required equipment (Endosafe® nexgen-PTS™, P200 Micropipettor, P1000 Micropipettor, Microcentrifuge) by selecting the appropriate resource for each field.

  2. Check All applicable information entered and Complete, then click Save. A "Worksheet Saved" confirmation toast will appear.

Part 9: Complete Protocol 4 — Endotoxin: Test Results & Approval

  1. On Protocol 4 of 4 — Endotoxin: Test Results & Appr..., click the Endotoxin Results File field and use the Resource Filters dialog to search by tag (e.g., "endotoxin") and select the results file (e.g., EndoScan.csv), then click Submit.

  2. Click the Start button next to the Ingest field to trigger automated ingestion of the results file. The status will display "running" while processing.

  3. Once ingestion completes, review the auto-populated result fields: Dilution Ratio, Sample Reaction Time CV%, Spike Reaction Time CV%, Spike Recovery%, Test Suitability (Pass/Fail), and Sample Value (EU/mL).

  4. Enter any manual fields as needed: Total Infusion Volume (mL) (e.g., 2), Patient Weight (Kg) (e.g., 20). The system will calculate Endotoxin Level (EU/Kg) automatically (e.g., 0.02).

  5. In the Next Step dropdown, select the appropriate option (e.g., Finished or Generate CoT - Endotoxin).

  6. Check All applicable information entered and Complete.

  7. Click Save, then click Submit to Next Workflow to advance the experiment to the Certificate of Testing (CoT) generation step.

Part 10: Complete the Approval Signature Flow

  1. After saving the completed results data, the Signature Flow tab becomes active on Protocol 4. Click the Signature Flow tab to view the Approval Signature Flow section.

  2. Click the Sign button (shown as "Needs Performer") to open the Sign ESP000058 dialog.

  3. In the signing dialog, select Approve as the action (the Approve tab is pre-selected).

  4. In the Performer row, the current user's credentials are pre-populated. Enter your password in the password field and set the reason dropdown to Accept, then click Signing... to submit the performer signature.

  5. Once the Performer signature is confirmed (shown as "Signed by Cortes, 1 minute ago — Accepted Reason: Accept"), a notification will appear: "QC Reviewer Signature Required."

  6. In the Reviewer row, enter the reviewer's username and password, set the reason to Accept, and click Signing... again to submit the reviewer signature.

  7. After the Reviewer signature is captured, a second notification appears: "QA Approver Signature Required."

  8. In the Approver row, enter the approver's username and password, set the reason to Accept, and click Signing... to complete the final signature.

  9. The Approval Signature Flow banner updates to "Signed", and the worksheet begins saving automatically (the top-right shows "Saving..."). The system then returns to the LIMS worksheet list.



Part 11: Open the Certificate of Testing (CoT) Worksheet

  1. Back on the LIMS worksheet list, the workflow chain has automatically generated a new downstream worksheet. Locate the "Endotoxin CoT - CW 22 Apr 2026" worksheet (workflow: Generate CoT - Endotoxin) at the top of the list and click it to open.

  2. The CoT worksheet opens showing Protocol 1 of 1 — Endotoxin Certificate of Test. Verify the auto-populated row for entity ESP000058 showing: QC Sample ID, Product Name (Study-22-1), Date of Testing (22Apr2026), Results (Pass), and Acceptance Criteria (Pass).



Part 12: Approve the Certificate of Testing

  1. In the Approved By column for the entity row, click the Approve button.

  2. The system triggers the Generate CoT pipeline. The Approved By field updates to show "Approved by Cortes at 1 minute ago", and the Start column shows "✓ done" with the Complete checkbox automatically checked.

  3. Click the done link in the Start column to open the Pipeline Run Details dialog and verify the pipeline completed successfully (Status: done, Pipeline: Generate CoT, Start and End times shown).

  4. Click Close to dismiss the Pipeline Run Details dialog.

  5. Click Save in the top-right corner to finalize and save the completed Certificate of Testing worksheet.