Test Drive: Executing a Batch Record with L7 MES

MES Execution: Phosphate Buffer SOP
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
2
Pre-Production
3
Day 1 Prep
4
Day 2 Prep
5
Endotoxin QC
1
Generate Data
Pre-requisite setup

Before starting, ensure that inventory entities exist in the system.

  1. 1
    From the home page, click Applet.
  2. 2
    Click on the Generate Data applet.
  3. 3
    To 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.
  4. 4
    To create all items at once, click Create All. A green dot will appear and all equipment instances will be created.
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
  1. 1
    From the home page, navigate to the Assets app.
  2. 2
    Click Kits.
  3. 3
    Click Add New Kit.
  4. 4
    Name the kit using your initials and the date — e.g., L7-CW-Demo-Kit-[date].
  5. 5
    Select 2-Phosphate Buffer Kit as the kit type.
  6. 6
    Set the status to Verified.
  7. 7
    Click Save. The new kit will appear with your logged-in user account as the owner.
  8. 8
    Click on the newly created kit.
  9. 9
    When prompted, click Add for each inventory item:

    • Add up to the minimum required quantity for each item.

    • You may mix and match lots — this is acceptable.

    • Items with no minimum (e.g., Nitric Acid Buffer) are optional.

    • All other items require the minimum quantity before the kit can be saved.
💡
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.
  1. 10
    Once all minimum quantities are added, click Save.
  2. 11
    Note the kit name — you will need it in the next phase.

3
Start a New Batch Record
Manufacturing Execution System
  1. 1
    From the home page, click Manufacturing Execution System.
  2. 2
    Click New Batch Record.
  3. 3
    In the Product field, select 2-Phosphate Buffer. The Product Type and MBR will populate automatically.
  4. 4
    Select the most recent, up-to-date MBR version.
  5. 5
    Enter a batch record name using your initials followed by a number — e.g., CW-001.
  6. 6
    Under Execution Plans, select the General DEP.
  7. 7
    Under Specification Plan, select your preferred option (e.g., "56 Bags and Two Levels").
Note: There are no separate Sample Plans or BOM Plans — these are incorporated into the General and Specification plans.
  1. 8
    Click Create.
  2. 9
    Wait 1–2 minutes for the batch record to be created. If it takes too long, refresh the page.
  3. 10
    Locate your batch record at the top of the list and click to open it.

4
Batch Start Execution
Workflow step 1
  1. 1
    Fill in all required fields on the batch start form:

    • Free text fields (e.g., production info): Enter relevant data or "N/A".

    • Production Room: Select the appropriate resource link.

    • Containers: Select from containers loaded in your instance.

    • Kit Selection: Select the kit you created in Phase 2.
  2. 2
    Click Submit to confirm the kit selection.
Important: This kit selection controls which inventory items are available to use downstream. Do not skip this step.
  1. 3
    Click Sign and enter your credentials to complete the sign-off.
  2. 4
    Click Complete then Save to advance to the next workflow.

5
Pre-Production Setup
Workflow step 2
  1. 1
    You will be automatically advanced to Pre-Production Setup after completing Batch Start.
  2. 2
    To check your progress at any time, click Unit Operations:

    • A checkmark (✓) indicates a completed workflow.

    • A pencil icon indicates the currently active workflow.

    • Pending workflows can be previewed but are not yet active.
  3. 3
    Work through the pre-production steps, filling in all required fields.
  4. 4
    Optional but recommended — use these features to prepare for Quality Review:

    • Toggle N/A for non-applicable fields.

    • Add Comments for any notable observations.

    • Flag Deviations where applicable (sent to Viva if integrated).

    • Add Sticky Notes for internal-only team communication.
  5. 5
    Attach any relevant files by dragging and dropping them into the attachment area.
Critical — Step 2.4: Prepare 1X Working Phosphate Buffer
  1. 1
    Navigate to Step 2.4.
  2. 2
    In the Material and Equipment Selections section, select the required materials (filtered to your kit) and pH meters (populated from the Generate Data applet).
  3. 3
    For range-based fields, enter your measured values. The system calculates compliance automatically. Out-of-range values will be flagged and sent to Quality Review.
  4. 4
    For QC Receipt, select Accept or Not Accept, then sign off.
  5. 5
    In the Next Step dropdown, select "Day 1 T-Rex Bantam 3 Preparation". This routes you to the correct Day 1 workflow.
  6. 6
    Sign off and save to complete Pre-Production Setup.

6
Day 1 and Day 2 Preparation
Workflow steps 3 & 4 — auto-transitions
  1. 1
    After completing Pre-Production Setup, the system will automatically transition you to Day 1.
  2. 2
    After completing Day 1, the system will automatically transition you to Day 2.
  3. 3
    Work through each step following the in-form instructions provided.
  4. 4
    Follow the same general flow throughout: fill in fields → sign → complete → save.

7
Endotoxin QC Testing
Workflow step 5 — auto-transition from Day 2
  1. 1
    After completing Day 2, the system will automatically transition you to Endotoxin QC Testing.
  2. 2
    Complete the lot information and QC assay selections.
  3. 3
    Select the required reagents and equipment.
  4. 4
    Upload the Endotoxin Results File:

    • Go to the Data app and search using the tag endotoxin or endoscan.

    • Run the Ingest to pull in all result data.
  5. 5
    Sign 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
  1. 1
    After completing all execution steps, go into Quality Review.
  2. 2
    Review any steps flagged for deviation, skipped fields, or N/A entries.
  3. 3
    Add comments or resolve any outstanding flags.
  4. 4
    Obtain two additional users to complete the required Operations and Quality sign-off.
  5. 5
    Complete the Final Batch Record sign-off.

📋
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.

🔑
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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