Standard Microsoft Dynamics 365 Finance & Supply Chain Management offers electronic signature requirements that can be applied to formula approval and activation, route approval and activation, and production order release.
To comply with 21 CFR Part 11 requirements, Life Sciences Supply Chain Management offers additional electronic signature requirements for GMP-critical actions/documents, such as resetting the batch disposition code or changing the material shelf life dates. Electronic signatures ensure that only authorized users can perform critical activities, allow appropriate control of documents, and support full traceability of user credentials and signature execution time.
STAEDEAN Life Sciences provides the electronic signature requirements listed below in the Electronic signature requirements form (Organization administration > Setup > Electronic signature > Electronic signature requirements), in addition to the ones provided by standard Microsoft Dynamics 365 Finance & Supply Chain Management.
Name | Procedure type | Description |
|---|---|---|
Activate date calculation rules | Built-in | Signature is required to activate a date calculation rule. |
Activate ER configuration | Built-in | Signature is required to activate an electronic reporting configuration. |
Activate material subtype | Built-in | Signature is required to activate a material subtype. |
Activate material type | Built-in | Signature is required to activate a material type. |
Activate storage conditions for items | Built-in | Signature is required to activate a storage condition associated with an item. |
Activate storage conditions for warehouses/locations | Built-in | Signature is required to activate a storage condition associated with a warehouse/location. |
Activate test group(*) | Built-in | Signature is required to activate a test group. |
Activate use code matrix configuration | Built-in | Signature is required to activate a use code matrix configuration. |
Approve date calculation rule | Built-in | Signature is required to approve a date calculation rule. |
Approve ER configuration | Built-in | Signature is required to approve an electronic reporting configuration. |
Approve item | Built-in | Signature is required to approve an item. |
Approve material subtype | Built-in | Signature is required to approve a material subtype. |
Approve material type | Built-in | Signature is required to approve a material type. |
Approve storage conditions | Built-in | Signature is required to approve a storage condition at the master level. |
Approve storage conditions for items | Built-in | Signature is required to approve a storage condition associated with an item. |
Approve storage conditions for warehouses/locations | Built-in | Signature is required to approve a storage condition associated with a warehouse/location. |
Approve test group(*) | Built-in | Signature is required to approve a test group. |
Approve use code matrix configuration | Built-in | Signature is required to approve a use code matrix configuration. |
Block/Unblock sub batches | Built-in | Signature is required to block/unblock a sub-batch. |
Copy bulk batch date | Built-in | Signature is required to copy the manufacturing date from a component to a manufactured batch. |
Quality order validation(*) | Built-in | Signature is required to validate a quality order. |
Reset batch disposition code | Built-in | Signature is required to manually change the disposition code of a batch. |
Reset intended use code – Planned order | Built-in | Signature is required to reset the intended use code for planned orders. |
Reset intended use code – Production order | Built-in | Signature is required to reset the intended use code for production orders. |
Reset intended use code – Purchase order | Built-in | Signature is required to reset the intended use code for purchase orders. |
Reset intended use code – Sales order | Built-in | Signature is required to reset the intended use code for sales orders. |
Reset intended use code – Transfer order | Built-in | Signature is required to reset the intended use code for transfer orders. |
Reset use code for batches | Built-in | Signature is required to manually change the use code of a batch. |
Reset use code for sub batches | Built-in | Signature is required to manually change the use code of a sub-batch. |
Reset vendor batch details | Built-in | Signature is required to manually enter or update the vendor batch details. |
Shipment approval | Built-in | Signature is required to approve the shipment of a product in a sales or transfer order. |
Update shelf life dates for batches | Built-in | Signature is required to manually enter or update the shelf life dates of a batch. |
Update shelf life dates for sub batches | Built-in | Signature is required to manually enter or update the shelf life dates of a sub-batch. |
Update work order status(**) | Built-in | Signature is required to manually update a work order status. |
(*) These electronic signature requirements are part of the Life Sciences Quality Control & Assurance.
(**) This electronic signature requirement is part of the Life Sciences Enterprise Asset Management.
Each electronic signature requirement can be activated by enabling the corresponding Signature required parameter.
Additionally, user-defined electronic signatures can be applied to selected tables and fields.