Signatures
Goals
Understand what signatures are in MES
Know how to model Signature Flows in L7|Master
Know how to add a Signature Flow to a Step
Understand what Sign Off is in MES
Know how to configure Sign Off for a Recipe
Key Terms
Term | Description |
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Sign Off | A tab in MES used to facilitate the final review of a Batch. |
Signature Flow | Structured signature queues configured in L7|Master. |
How do Users provide signatures during Batch production?
Throughout production Users need to indicate who performed and who observed/verified each Step in the Batch Record. Users enter their L7|ESP username and password to record their signature, which is part of a Signature Flow configured in L7|Master. The signer does not have to be the logged-in User.
Note
Completed signatures record the reason, username, and date time of the signature, making them 21 CFR Part 11 compliant.
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How to model Signature Flows
Go to: Builders (L7|Master) -> Signature Flow -> + New Signature Flow
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Signature Flow Details Panel
Name – name of the Signature Flow
Description (optional) – description of the Signature Flow
Tags (optional) – keywords associated with the Signature Flow, can be used to search or reference the signature flow
Signatures – read-only field displaying the total number of signatures in the Signature Flow
Accept Reasons – list of reasons the User can select from to indicate why they are providing a signature of approval.
Reject Reasons – list of reasons the User can select from to indicate why they are providing a signature of rejection
Note
MES does not display reject reasons - all signatures denote approval.
Version – saved changes create a new version of the Signature Flow, which can be pinned with a unique name
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Signature Flow Builder
When building a Signature Flow, each signature is depicted as a card with configurable settings. Drag and drop signature cards to change the sequential order of signatures.
Type – who will be performing the signature, configured by Owner, User, Role, or Workgroup
Note
The Nominated by previous signer option is available after the first signature when configured by User, Role, or Workgroup. By default, the signer cannot nominate themselves.
Note
Without nomination, it is possible for the same person to sign more than once.
Description (optional) – description of the signature
Advanced (optional) settings:
Signature is optional – only available if nominated by previous signer.
Note
The first stage of a Signature Flow is always required. All subsequent stages are optional, unless Block process progress until signed is selected.
Optional stages with a nominated signer that are incomplete appear as exceptions in the Quality Review tab, but can be signed at any time during production, even if the Step is already complete.
Allow self nomination – only available if nominated by previous signer.
Label – acceptance reason for the Signature; if the label is left blank, the signer will select one (1) of the acceptance reasons in the details panel from a picklist
ID – fixed value used to reference the signature
Block process progress until signed - indicates that the signature is required to complete a Step
Data modification policy – defines the interplay between the signature and the data being signed off on, options include: allow data change, resign on data change, and signature locks data
Note
It is best practice to have the last stage of the Signature Flow lock the data.
Resign on data change is not supported in MES.
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Note
Once saved, Signature Flows can be added to a Step in the Protocol builder as an Approval field.
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Signature Flows can be configured to auto-complete the Step:
Never
Once all progress-blocking signatures are complete
Once all signatures are complete
Note
Auto-completion requires the Signature Flow to be the last field in the Protocol.
Warning
Auto-completion is currently broken in MES
What does it mean to Sign Off in MES?
The Sign Off tab provides a mechanism for final review of a Batch in MES. Signatures can only be entered in this tab after completion of Quality Review.
The signatures presented in Sign Off tab are governed by the Signature Flow associated with the Batch Recipe. Signatures must be provided in order, but the signer does not have to be the logged-in User.
Once all signatures are entered, the Batch status is updated to Complete.
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How to configure Batch Sign Off
To configure Batch Sign Off:
Navigate to L7|Master → Workflow Chains
Select the desired Recipe
Select the Custom Fields tab
Click + Add Custom Field
Enter a Display Name
Select Signature Flow as the Type
Select the desired Signature Flow
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