Best Practice: MES Batch Template Development Guide

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  • 公開日 Dec 16, 2025
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MES Batch Template Development Guide

This document outlines how to build an end-to-end batch manufacturing process in Apprentice, covering equipment and material setup, batch template creation, execution logic, deviation handling, review, and Integrations. It is intended for MES engineers, technical leads, and customer teams developing compliant digital workflows.

1. Global Settings Configuration (System Admin)

✅ Steps:

  • Settings
    • High Level Settings for the Environment Displayed to System Administrators
      • Team Name
      • Date/Time Format
      • Time Zone
      • AWS S3 Bucket
    • Organization Logo
      • Allows you to upload an Organization Logo that will be attached to all batch run PDF reports
  • Permissions
    • Toggles that would apply to all users:
      • Signatures
        • Require Signature to Create a Batch
        • Require Second Signature to Lock and Plan a Batch Run
        • Require Signature to create and execute effective Procedure Runs
        • Full Recipe Review and Approval Required
      • Resources
        • Prevent changes to resources referenced in effective procedure templates
      • Overrides
        • Allow a user to approve their own overrides on mobile and web
  • Single Sign On
    • Configure SSO with your identity provider
  • Pin/Password Settings
    • Password Settings (for local accounts / non SSO)
      • Define number of days for password rotation
    • Pin Settings
      • Configure a 6 to 8 digit pin length
      • Define Pin Rotation Settings (30, 60, 90 days)
  • Exceptions and Quality Data
    • Define Default Severity Based on a group of process actions or individual process actions
      • Process Action Groups
        • Critical Values
        • Process Exceptions
        • Process Notes
        • Resource Exceptions
        • Value Exceptions
        • External Exceptions
      • Default Severity
        • Info
        • Low
        • Medium
        • High
        • Critical
      • Signature Requirement
        • One signature approval
        • Two signature approval
      • Trigger Exception & Quality Data Capture
        • Trigger
        • Do Not Trigger
  • Signatures
    • Configure signature reasons for all users in the system

  • Web Execution
    • Configure Barcode Scanner Settings

Locations Overview:

  • Define and manage the different locations used in the drug production process. Resource management structures can easily be defined that reflect the hierarchies, profiles, and statuses of materials and other critical operating elements.
  • In the Tempo Manufacturing Cloud, locations are used to:
    • Reflect the hierarchy of locations where batches and procedures are executed by your organization
    • Track where material and equipment resources are stored for auditing and procedure execution purposes
  • Hierarchy
    • Site
      • A site is the location that sits at the top of the locations hierarchy in the system. Sites contain information such as the main facility's address, city, state, country, and zip code details. Each location configuration always begins with a site.
    • Building
      • A building is the second level of the locations hierarchy in the system. A building might represent the information for a single building within a larger site (e.g., a specific warehouse). Users can attach buildings to site locations in the system.
    • Area
      • An area is the third level of the locations hierarchy in the system. An area might represent the information for a single area within a larger building (e.g., a packaging area). Users can attach areas to site and building locations in the system.
    • Unit
      • A unit is the fourth and final level of the locations hierarchy in the system. A unit might represent the infomation for a single unit within a larger area (e.g., a dry freezer). A unit may contain resources such as material or equipment. Users can attach units to site, building, and area locations in the system. After configuring a unit, the following tabs display:
        • Material and Equipment Compatibility Tabs
        • Usage Log Tabs
        • Statuses Tabs
  • Material and Equipment Compatibility Tabs
    • After configuring a unit, users can add compatible material and equipment classes to the unit via the Material or Equipment Compatibility tabs. Adding a material or equipment class helps track and determine which material or equipment resources are approved to be contained in the unit.

2. Equipment Configuration 

✅ Steps:

Tip: Leverage CSV Import for Bulk Upload of Classes, Subclasses, Instances

  • Identify required equipment per procedure template.
  • Configure Equipment Classes/Subclasses within Tempo
    • Equipment Class Configuration
      • Name
      • Description
      • Statuses
      • ERP Managed Equipment Class
      • Integration Configuration
      • Equipment Class Requires Calibration
      • Equipment Class is a Scale
    • Standard Properties
      • Attach standard properties to a class that then applies to all equipment instances within that class
    • Custom Properties
      • Attach specific attributes to the class or subclass that is not included by default
    • Triggers
      • Ways to trigger status changes based on a timer, counter, or recurring

  • Configure Equipment Instances
    • Define Class and Subclass for the instance
    • Equipment Name, ID and Vendor Name are required fields
    • Generates a barcode, or allows you to map to existing barcodes through “Scan ID” field
    • Equipment assets allow you to interact with equipment via the procedure and batch templates - trigger status changes, etc.
    • When scanning a piece of equipment that is not part of a compatible location, or is out of use, the system will generate an exception which can be configured as blocking if necessary

  • Document status and leverage Tempo logs to track lifecycle of equipment
    • Attach documents to the run if tracking status externally

  • Block equipment for exclusive use in the current batch.
    • Equipment will be blocked if not in a usable state or not compatible with a specific room
    • Blocking Exception configuration at the procedure template level would cause operators to be paused until the exception went through quality review

3. Material Configuration

✅ Steps:

Tip: Leverage CSV Import for Bulk Upload of Classes, Subclasses, Instances

  • Identify required materials per procedure template.
  • Configure Material Classes/Subclasses within Tempo
    • Material Class Configuration
      • Name
      • Description
      • Statuses
      • ERP Managed Material Class
        • Enabling this option will allow ERP integration to create and maintain Material Data
    • Custom Properties
      • Configure based on “Level”
        • Material Definition
        • Lot
        • Sublot
  • Configure Material Definitions
    • Define Class and Subclass for the definition
    • Material Name, ID, UoM and Default QC Status are required fields
    • Generates a barcode, or allows you to map to existing barcodes through “Scan ID” field
    • When scanning a material that is not part of a compatible location, or is not in an approved QC status, the system will generate an exception which can be configured as blocking if necessary

  • Configure Material Lots

https://navigator.apprentice.io/docs/material-lots-material-inventory-overview


    • After a material definition is configured, Quality, Supervisory, and System Admin users can allocate quantities of material inventory to a lot and/or sublot. In the system, a material lot is recognized as the parent lot in the hierarchy, which contains sublots of material inventory.
    • Material ID/Name, Lot #, Lot Status and Expiration Date are required fields
    • Material lots and sublots allow organizations to manage, store, and track their material inventory. When a material definition is assigned a lot or sublot, an organization can identify the exact locations and quantities of their materials in the manufacturing facility.

  • Configure Material Inventory (Sublot) - https://navigator.apprentice.io/docs/add-edit-move-deactivate-material-lot-sublot
    • Material ID/Name, Lot Number, Sublot ID, Location, QC Status and Total Quantity are required fields
    • Material Definitions/Lots/Sublots allow you to interact with materials via the procedure and batch templates - dispense, consume, material output, use kit, create label, etc.
    • Ability to move sublots to existing or new sublots
  • After a material definition is configured, Quality, Supervisory, and System Admin users can allocate quantities of material inventory to a lot and/or sublot. In the system, a material lot is recognized as the parent lot in the hierarchy, which contains sublots of material inventory.
  • Material lots and sublots allow organizations to manage, store, and track their material inventory. When a material definition is assigned a lot or sublot, an organization can identify the exact locations and quantities of their materials in the manufacturing facility.
  • Adding a material sublot from a material definition
    • From the left navigation panel, click cloud Tempo > Materials > Material Definitions.
    • Locate then select the material definition from the list that you want to add a sublot to.
    • Click the Material Lots tab.
    • Locate the material lot that you wish to add the sublot to, then click expand_more Expand.
    • Click Add Sublot. The Add Sublot dialog displays.
    • Select or enter the information in the required fields:
      • Sublot Name: The name of the sublot.
    • QC Status: The quality control status of the material definition's sublot in the system. The default is whichever option was selected at the time of material creation.
    • Location: The available location in the system that this material lot is stored in.
    • Total Quantity: The total number of material inventory allocated to this material sublot.
  • Moving a material sublot from a material definition
    • From the left navigation panel, click cloud Tempo > Materials > Material Definitions.
    • Locate then select the material definition from the list with the applicable lot.
    • Click the Material Lots tab.
    • Locate the material lot with the applicable sublot, then click expand_more Expand.
    • Locate the sublot that you want to move, then click swap_horiz Move Sublot. The Move Sublot dialog opens with the To existing sublot tab displayed by default.
    • Determine if the sublot inventory needs to be moved to an existing sublot in the system (To existing sublot) or to a new sublot (To new sublot), then proceed to the applicable section below.
  • To existing sublot
    • Select and enter the information in the required fields.
    • Move quantity: Provide the total quantity of material inventory from the selected sublot that you want to allocate elsewhere.
    • Existing sublot: Select the existing sublot from the lot to allocate the inventory to.
    • Click Move.
    • Sign off on the inventory move, then click Submit.
  • To new sublot
    • Click the To new sublot tab.
    • Select and enter the information in the required fields.
    • Move quantity: Provide the total quantity of material inventory from the selected sublot that you want to allocate elsewhere.
    • Move to compatible location: Select a compatible location to move the sublot to.
    • New Sublot ID: The unique ID for the new sublot.
    • Click Move. The new sublot with the allocated inventory displays.
    • Sign off on the inventory move, then click Submit.
  • Deactivating a material sublot from a material definition
    • From the left navigation panel, click cloud Tempo > Materials > Material Definitions.
    • Locate then select the material definition from the list with the applicable lot.
    • Click the Material Lots tab.
    • Locate the material lot with the applicable sublot, then click expand_more Expand.
    • Locate the applicable sublot, then click delete Deactivate Sublot. The Deactivate Sublot dialog displays.
    • Sign off on the deactivation, then click Deactivate.

4. Procedure Template Creation

✅ Steps:

  • Select an existing MBR (Master Batch Record) as a starting point
  • Develop Process Flow, Create Required Steps (Visual Builder)
  • Populate Steps with:
    • Step Name
    • Text Instructions
    • Technique Media (Photo / Video Content to help guide operators)
    • Process Actions
      • Inputs that the operator would interact with to capture data
        • Manual or Pulled via Integration
      • Process Action Types:
        • Inputs




        • Materials




        • Equipment




        • Samples




        • Automation




        • Integrations




        • More


    • Signatures


    • Step Navigation

  • Leverage Procedure Configuration Tab to Define Execution Rules
    • Review and Approval Required
      • If checked, template must go through full quality review cycle
      • Cycle is: Draft > Review > Approval > Lock and Make Effective
    • Enforce Step Sequentiality
      • Requires Operators to go in step order
      • If operators try to go out of order, an exception will be generated
    • Enforce Process Action Sequentiality
      • Requires Operators to execute actions within a step in order
      • If operators try to go out of order, an exception will be generated
    • Not Applicable Enabled
      • Gives operators the ability to “N/A” specific process Actions
    • Blocking Exceptions
      • Blocks operators from moving forward based on the type of exception that is raised
        • Requires quality review and approval of exception before they can execute again
    • Integrations Settings
      • PI Event Frame Generation
        • If enabled, the procedure will automatically create Pi event frames with relevant step details in the target Pi integration
      • Sync Technique Media with DMS
        • If enabled, the procedure will automatically sync Technique Media uploads into the target DMS integration
  • Leverage the Tempo Dashboard (on web) for high level monitoring.

5. Execute Parallel, Sequential, and Repeating Steps

✅ Steps:

Procedure Level

  • Leverage Visual Builder to configure parallel paths, sequential tasks, parallel execution, as well as repeated operations.
  • Multiple Paths must resolve to a single step
  • Configure “If” “Else If” “Else” logic in the step navigation tab to achieve the necessary use case
    • Operator / Integration input will determine which path the operator goes down
    • Step Navigation is built off of the condition process action
  • Step Navigation provides a “Repeat Step” checkbox for any steps that need to be executed N number of times

6. Batch Template Creation

✅ Steps:

  • Once procedures for the selected MBR have been locked and made effective, batch template creation can begin
  • Under Batches
    • Select Create New Template
    • Define Batch Template ID
      • Option Fields for:
        • Product Material
        • Program
        • Phase
        • Customer
        • Tags
    • Assign Additional Authors
    • Configure Batch Template Settings
      • Review and Approval is Required for this batch template
        • If checked, template must go through full quality review cycle
        • Cycle is: Draft > Review > Approval > Lock and Make Effective
      • Enforce Sequentiality
        • If enabled, users will be required to progress through every procedure and unit operation in sequential order.
      • Required Documents Must be Uploaded to Complete a Batch Run
        • If enabled, users will be required to upload any specified documents to the batch run before the batch run can be released.
      • Allow Using Retired Procedure Template Versions
        • If enabled, users will be able to start batch runs using this batch template if it contains procedure templates in retired state.
      • Enable Pi Event Frame Generation
        • If enabled, the procedure will automatically create PI Event Frames with all Relevant Step Details in the target PI Integration
    • Users can add N number of Unit Operations with N number of procedure templates within a batch template
    • Batch Templates automatically pull parameters from the procedures that are added
      • This allows for parameter passing to be configured across procedures within a batch template through dynamic parameterization
      • Options to set parameter values as “Static” or “Dynamic”
    • Parameter Groups can be created and applied so that a single batch template can serve N number of Products

7. Deviation Identification and Approval

✅ Steps:

  • Apprentice automatically generates exceptions based on Global Exception configuration settings, which applies to all templates, runs, users

  • Exceptions can be defined by group (Process Exceptions, Critical Values, Value Exceptions, etc.) or by individual process action
  • Exceptions can be configured to
    • Trigger or Not Trigger An Exception
    • Require One or Two Signature Approvals
    • Have a Default Severity (Info, Low, Medium, High, Critical)
  • Closure rules allow you to require at least one comment to close an exception
  • Define specific users or groups of users that are allowed to review and approve exceptions
  • Optionally, you can configure Blocking Exceptions on a procedure by procedure basic.
    • Blocking exceptions kick an operator out of a run until quality has had an opportunity to review and approve the exception
  • Integrating with QMS
    • With integrating to a QMS, users have the option to send exceptions to the QMS to initiate deviation investigations outside of Apprentice

8. Batch Record Review, Approval, and Sign-Off

✅ Steps:

  • Route full EBR for QA/QC review.
    • Batch Review Stages:
      • Created
      • Planned
      • In Progress
      • Completed (Awaiting Review)
      • Review Complete
      • Released
      • On Hold
      • Aborted
    • In order to progress to the next stage, all exceptions must be approved, all required documents must be uploaded, and each completed procedure run within the batch run must be approved.
      • To view a specific procedure run in a separate browser tab, click the Summary tab, then click the more_horiz More Options icon next to any procedure name and click Procedure Run.
  • Collect customer approval (if required)
    • Customers can gain direct access to review within Apprentice through the Connected Manufacturing Network

🛠️ Tips:

  • Utilize Tempo’s 'review by exception' to streamline QA.
  • Configure approval workflows and role-based access.

9. Integrations and Data Sharing

✅ Steps:

  • Apprentice supports multiple no code integrations as well as leveraging a Custom API to support additional integrations
  • API Documentation is available through PostMan for each major release
    • API can be leveraged to extract data from the system to trend in PowerBI or a similar tool
  • Apprentice’s integration team can work with you to support requirements gathering and setting up the integration to meet the use case