eDHR Validation and Sign-off#

Overview#

The eDHR Validation and Sign-off feature aims to ensure each batch, lot, or unit are manufactured according to specifications collected for a Manufacturing Report (eBR and eDHR).

Concept#

Have a mechanism to associate a Material (or group of Materials) to a Validation Protocol, export reports to PDF, and attach them as Documents to the Protocol.

Setting up a Protocol Validation#

Protocol#

Set up the Protocol that shall be used for validation.

SmartTable#

It's necessary to configure the Smart Table MedDevMaterialProtocolContext used in the Protocol validation. Properties to resolve:

Protocol: Defines the Protocol definition to open a Protocol Instance

Operation: Defines the validation operation. Two operations are supported:

• AssociateMaterial: Associate the material to a Protocol Instance, no report is generated

• AttachDocument: Generate a report and attach it as a document to the Protocol Instance

GroupingProperty: Defines which property to group the materials by. The following properties are supported:

• Production Order: Group materials by Production Order

• Manufacturer Lot Number: Group materials by Manufacturer Lot Number. Should be used when the validation is done at lot level (Continuous Flows)

• Name: Group materials by Name. Should be used if only the Material itself should be associated with the Protocol Instance

GroupingRule: Defines a custom Rule to group the materials

Report: Defines the Report to be generated when Operation is AttachDocument

Note: the value added to this Smart Table should follow some rules

1. The Step has MedDevIsMatProtocolStep attribute enabled
2. If Operation is AssociateMaterial, one and only one of GroupingProperty or GroupingRule is set.
3. If Operation is AttachDocument, the Report column must be set.

Execution Behavior#

This feature is triggered when the Step has attribute MedDevIsMatProtocolStep enabled.

When Material is moved to the next step or tracked out, the feature executes the following sequence:

1.Resolve Context

The Smart Table MedDevMaterialProtocolContext is resolved using the current step and material context to determine:

• The target Validation Protocol

• The required Operation (AssociateMaterial or AttachDocument)

• The Grouping criteria (e.g. by Name, Production Order, Manufacturer Lot Number or a Rule)

• The associated Report (if applicable)

2.Identify Existing Protocol Instance

The feature evaluates the instance of the resolved Protocol from the material group (Grouping Property or Grouping Rule).

3.Perform Operation

Depending on the resolved operation:

• If Operation = AssociateMaterial, the grouped materials are added to the existing (or newly created) protocol instance. No report is generated. In the example below, both Mat_Protocol and Mat_Protocol.02 belong to the same group so both materials were assigned to the Protocol Instance.

• If Operation = AttachDocument, a PDF report will be generated in the background. Upon successful generation, the PDF will be attached as a document to the Protocol Instance.

This behavior ensures that materials are correctly grouped under validation protocols early in the process, while compliance documentation (eDHR/eBR) is produced only when complete and accurate data is available.

Administration#

Attribute#

Set the Attribute MedDevIsMatProtocolStep of a Step to true.

MedDevMaterialProtocolOperations Lookup Table#

MedDevMaterialProtocolOperations is a Lookup Table used in SmartTable MedDevMaterialProtocolContext to configure the Property Operation, it contains "AssociateMaterial" and "AttachDocument".

MedDevMaterialProtocolGroupingProperties Lookup Table#

MedDevMaterialProtocolGroupingProperties is a Lookup Table used in SmartTable MedDevMaterialProtocolContext to configure the Property GroupingProperty, it contains "Name", "Production Order" and "Manufacturer Lot Number".