Workflow Normal Mode vs. Advanced (GxP) Mode

LabCollector offers two distinct workflow modes: Normal Mode and Advanced (GxP) Mode. These modes cater to different user requirements and regulatory needs. Below, we provide a comprehensive breakdown of each mode along with detailed explanations and examples.

SUMMARY:

1. Workflow normal mode

1.1. Normal Template Creation

1.2. Template Configuration Options

1.3. Template Design

1.4. “Stage” Node

2. Workflow GxP mode

2.1. Master Template Creation

2.2. Template Configuration Options

2.3. Nodes Options

2.4. Additional Step in the Stage node: Verification

1. Workflow Normal mode:

1.1. Normal Template Creation:
In the Normal Mode, users can create standard workflow templates suitable for routine laboratory processes that don’t require advanced regulatory compliance features.

1.2. Template Configuration Options:
– Email Alerts: You have the option to notify responsible(s) for the next job step/node. When this option is selected, LabCollector will send email notifications to individuals responsible for the subsequent steps or nodes in the workflow.

For example: When a sample is ready for analysis, an email alert is sent to the laboratory technician responsible for the next step.

– Validate User: You can select whether your template require user authentication upon completing nodes. Enabling this option ensures that only authorized personnel with the necessary credentials can proceed to the next step in the workflow.

For example: In a pharmaceutical lab, analysts must authenticate themselves with their LabCollector login credentials before they can access and complete specific workflow steps involving sensitive data.

– Record’s Name: This setting determines how the name of the workflow template is included in the names of records created using this template.
You can select amongst three options:
a. No repeat (meaning that the workflow name won’t get repeated in the record’s name)
b. Repeat workflow’s name in record’s name field (first node only)
c. Repeat workflow’s name in record’s name field (all nodes)

For example: Suppose you choose option 2. If your workflow template is named “Quality Control,” the first record created using this template might be named “Quality Control – Batch 1.”

– Project Code: Similar to the Record’s Name setting, this option defines how the project code associated with the workflow template is included in the records’ project code fields.
You can select amongst three options:
a. No repeat
b. Repeat workflow’s project code in record’s project code field (first node only)
c. Repeat workflow’s project code in record’s project code field (all nodes)

For example: If you choose option 3, and the project code is “PC123,” all records created using this template will have “PC123” in their project code fields.

– Record Data View Mode: This setting controls the visibility of data within records created using the template.
You can select amongst three options:
a. All data visible by default
b. No data visible by default (click to open)
c. Data visible by default only on the first record (click to open additional records)

For example: Option 2 might be used when sensitive data should not be visible immediately but can be accessed by clicking to open the record for further details.

1.3. Template Design:
Workflow Normal Mode permits the creation of templates with up to 13 nodes. These bricks include start, end, module, box/plate, stage, recipe, derivation, link, storage, LC tool stage, E-sign, add-on stage, and remote stage.

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1.4. “Stage” Node:
The node “Stage” allows you to include general information, module forms, product details, equipment requirements, and alternative steps.

2. Workflow GxP mode:

2.1. Normal Template Creation + Master Template Creation:
Workflow GxP Mode offers the flexibility to create both normal and master templates. This mode is essential for laboratories operating in highly regulated environments.

2.2. Template Configuration Options:
Workflow GxP Mode includes all options from Normal Mode and introduces several more advanced features:

– Automatic Naming: Assigns a unique random ID as the name of the workflow.

For example: A unique random ID (e.g., WFD12345) is automatically generated as the workflow name.

– Automatic Start (Select Existing Record from Workflow Name): You have three options:
a. No automatic start
b. Automatic start (create new record with the workflow’s name)
c. Automatic start (select existing record from the workflow name): with three additional options:

• Lock Records Created: This option allows for records created through the automatic start feature to be locked, preventing further modifications.
• Block Duplicate Records (Automatic Start with New Record Creation Only): Enabling this option prevents the creation of duplicate records when starting a new workflow.
• Ignore Affix Value (Automatic Start with Record Selection Only): This option allows users to initiate workflows by selecting an existing record without considering affix values.

– Start Permissions: This allows you to define which users can start a workflow with this template (validated version).
Options include administrators, administrators and staff plus, administrators, staff plus, staff, or all users.

For example: You can restrict the initiation of a critical workflow to only administrators and staff members with specific privileges.

2.3. Nodes Options:
Nodes in GxP Mode offer additional options for validation and duplication, providing more control over the workflow process.

2.4. Additional Step in the Stage node: Verification:
Users can add a verification step to the node stage, selecting from different verification types, including disabled, simple (without a password), use LabCollector login password, and use a specific password.

For example: A “verification” step with LabCollector login password can enhance security by requiring users to provide their LabCollector credentials before proceeding with a critical stage.

Related topics:

• Check our KB on how to use Workflow Manager add-on.
• See how to start a job in LSM.
• See how to perform QC validation in LSM.