
Test Drive: Executing a Batch Record with L7 MES

Test Drive · MES Execution
Phosphate Buffer SOP
Step-by-step walkthrough for executing the 2-Phosphate Buffer batch record in the Manufacturing Execution System.
1
Batch Start
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2
Pre-Production
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3
Day 1 Prep
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4
Day 2 Prep
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5
Endotoxin QC
1
Generate Data
Pre-requisite setup
Before starting, ensure that inventory entities exist in the system.
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1From the home page, click Applet.
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2Click on the Generate Data applet.
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3To create individual items, click on a specific item (e.g., "One Nitric Acid Buffer") and click Create. A green dot will appear and the log will confirm the created instances.
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4To create all items at once, click Create All. A green dot will appear and all equipment instances will be created.
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Note: Use this applet as many times as needed. It can generate samples, items, equipment, and containers — replacing the need for manual flat file ingestion.
2
Create a Kit
Assets app
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1From the home page, navigate to the Assets app.
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2Click Kits.
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3Click Add New Kit.
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4Name the kit using your initials and the date — e.g.,
L7-CW-Demo-Kit-[date]. -
5Select 2-Phosphate Buffer Kit as the kit type.
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6Set the status to Verified.
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7Click Save. The new kit will appear with your logged-in user account as the owner.
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8Click on the newly created kit.
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9When prompted, click Add for each inventory item:
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Add up to the minimum required quantity for each item.
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You may mix and match lots — this is acceptable.
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Items with no minimum (e.g., Nitric Acid Buffer) are optional.
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All other items require the minimum quantity before the kit can be saved.
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Tip: If you don't have enough quantity, go to the Inventory app to add more, or return to the Generate Data applet to create additional instances.
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10Once all minimum quantities are added, click Save.
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11Note the kit name — you will need it in the next phase.
3
Start a New Batch Record
Manufacturing Execution System
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1From the home page, click Manufacturing Execution System.
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2Click New Batch Record.
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3In the Product field, select 2-Phosphate Buffer. The Product Type and MBR will populate automatically.
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4Select the most recent, up-to-date MBR version.
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5Enter a batch record name using your initials followed by a number — e.g.,
CW-001. -
6Under Execution Plans, select the General DEP.
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7Under Specification Plan, select your preferred option (e.g., "56 Bags and Two Levels").
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Note: There are no separate Sample Plans or BOM Plans — these are incorporated into the General and Specification plans.
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8Click Create.
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9Wait 1–2 minutes for the batch record to be created. If it takes too long, refresh the page.
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10Locate your batch record at the top of the list and click to open it.
4
Batch Start Execution
Workflow step 1
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1Fill in all required fields on the batch start form:
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Free text fields (e.g., production info): Enter relevant data or "N/A".
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Production Room: Select the appropriate resource link.
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Containers: Select from containers loaded in your instance.
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Kit Selection: Select the kit you created in Phase 2.
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2Click Submit to confirm the kit selection.
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Important: This kit selection controls which inventory items are available to use downstream. Do not skip this step.
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3Click Sign and enter your credentials to complete the sign-off.
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4Click Complete then Save to advance to the next workflow.
5
Pre-Production Setup
Workflow step 2
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1You will be automatically advanced to Pre-Production Setup after completing Batch Start.
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2To check your progress at any time, click Unit Operations:
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A checkmark (✓) indicates a completed workflow.
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A pencil icon indicates the currently active workflow.
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Pending workflows can be previewed but are not yet active.
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3Work through the pre-production steps, filling in all required fields.
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4Optional but recommended — use these features to prepare for Quality Review:
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Toggle N/A for non-applicable fields.
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Add Comments for any notable observations.
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Flag Deviations where applicable (sent to Viva if integrated).
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Add Sticky Notes for internal-only team communication.
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5Attach any relevant files by dragging and dropping them into the attachment area.
Critical — Step 2.4: Prepare 1X Working Phosphate Buffer
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1Navigate to Step 2.4.
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2In the Material and Equipment Selections section, select the required materials (filtered to your kit) and pH meters (populated from the Generate Data applet).
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3For range-based fields, enter your measured values. The system calculates compliance automatically. Out-of-range values will be flagged and sent to Quality Review.
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4For QC Receipt, select Accept or Not Accept, then sign off.
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5In the Next Step dropdown, select "Day 1 T-Rex Bantam 3 Preparation". This routes you to the correct Day 1 workflow.
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6Sign off and save to complete Pre-Production Setup.
6
Day 1 and Day 2 Preparation
Workflow steps 3 & 4 — auto-transitions
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1After completing Pre-Production Setup, the system will automatically transition you to Day 1.
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2After completing Day 1, the system will automatically transition you to Day 2.
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3Work through each step following the in-form instructions provided.
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4Follow the same general flow throughout: fill in fields → sign → complete → save.
7
Endotoxin QC Testing
Workflow step 5 — auto-transition from Day 2
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1After completing Day 2, the system will automatically transition you to Endotoxin QC Testing.
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2Complete the lot information and QC assay selections.
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3Select the required reagents and equipment.
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4Upload the Endotoxin Results File:
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Go to the Data app and search using the tag
endotoxinorendoscan. -
Run the Ingest to pull in all result data.
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5Sign off to complete the endotoxin test.
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Tip: This test can also be run in LIMS for an alternative view — you may find it easier to navigate there. You can also copy the workflow chain to try other tests (e.g., the ELISA test) inline.
8
Quality Review and Final Sign-Off
Completion
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1After completing all execution steps, go into Quality Review.
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2Review any steps flagged for deviation, skipped fields, or N/A entries.
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3Add comments or resolve any outstanding flags.
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4Obtain two additional users to complete the required Operations and Quality sign-off.
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5Complete the Final Batch Record sign-off.
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Batch Record Tabs Reference
Overview of available data views
| Tab | Contents |
|---|---|
| Reports | Generate reports at any time; incomplete steps will be flagged. |
| Specifications | Actual vs. expected values with units of measure. |
| BOM (Bill of Materials) | All reagents and items logged in item/equipment usage fields. |
| Bill of Equipment | Equipment-only usage log. |
| Sample Plan | Sample data pulled from the endotoxin test. |
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Credentials Reminder
Sign-off access
MES Execution
Use credentials provided for each stage of MES sign-off.
LIMS Sign-offs
Use the same credentials provided for LIMS-side sign-offs.
Quality Review
Separate quality review credentials have been provided.
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