The eCHR profiles define what subset of production data is going to be included in the eCHR. It also defines the signature requirements, the languages that the final eCHR will be translated into, how splits are managed, and defines the content and format of the summary text displayed on the listing page.

In a production workflow you select which eCHR Profile will apply for that workflow. An item can only have one eCHR Profile. 

When you create a job, it's created against a scheduled workflow and therefore the eCHR Profile that will be used. The profile determines what will be stored when making an item. 

If you spawn a task from a parent workflow (i.e. go to a Start New Task workflow such as rework or a planned inspection workflow), the data from the spawned task will only be written to the eCHR for the item if it were set up to do so in the parent workflow. You can't have a separate eCHR profile for the spawned task.

If you transfer one item from one scheduled workflow to a different scheduled workflow, you can only do that if the second workflow is valid for the same eCHR profile assigned. 

eCHR Profiles are versionable. Each version is assigned sections and each section contains configuration which determines what content is saved in the eCHR.

Major and Minor eCHR Profile Versions

eCHR Profiles are versionable to support change control. 

eCHR Profiles have a major and minor version. Minor upversions can be used to minimise approval admin where a change can be applied to existing workflows without upversioning and approving the workflows that reference the eCHR Profile. For example, you might make a cosmetic change to the format of the line summary information without altering the underlying data. You would want this change to apply across all workflows that reference the eCHR Profile, without needing to create and approve a new version of each workflow. 

Major versions can be used to enforce more substantial changes such as the data to be included in the eCHR and this would require a new workflow version to be approved to control and authorise the change.

eCHR Profile Configuration

An eCHR Profile has versions. Each version has a header and a number of lines that are grouped into one or more sections. The image shows the structure of the eCHR Profile.

• eCHR Profile: Name of the eCHR profile allowing easy linking to applicable products.
• eCHR Profile Version: It is the definition and status of versions of the profile and top-level controls for associated eCHRs and it contains definition of the format of the header. The eCHR Profile version contains the following:
  • Definition of the format of the header that's displayed in the Details column of the eCHR Listing page. 
  • Definition of the transactions that are permitted
  • eSignature requirements.
  • Languages of the printable report.
  • How splits are to be managed.
  • How multiple items on a job are managed (i.e. all on the same eCHR vs each item on its own eCHR).
  • Associated sections and lines.
• eCHR Section: Defines the top level structure of lines into an easily readable layout, for example, "Product Definition which contains documents and bill of materials information". The section header contains the user-defined name for the sections that will be displayed as the section label in the Content page of the eCHR Listing. Contains the configuration of the data for each of the sections you want to define.
• eCHR Subsection: Where needed a subsection can define a secondary grouping of data. For example, group check results by op number (that this is only available currently in advanced settings).
• eCHR Line: Defines the exact data to be recorded and the display for that data, including what data is used in the summary and what is detailed info.
• Re-Order Sections: This button (not displayed in the screen image above) allows you to re-order eCHR Profile Sections for improved control of the layout of reports.

Manage Transaction Controls

This controls what you can and cannot do on items with an eCHR depending on the status of the eCHR. For more information, see Manage Transaction Controls. 

Create an eCHR Profile

1. Navigate to the eCHR Profiles page.
2. Click the New Profile button.
3. Complete the New eCHR Profile input screen.

New eCHR Profile

Blue fields in the form are required and are flagged with an asterisk (*) in this document. 

• Name*: Provide a unique name for the profile.
• Header Summary Syntax*: Defines the data that will be displayed in the Details column of the eCHR Listing. This section is pre-configured but is editable if you wish to add or remove data earmarked for the eCHR. If however, you need to do this, contact Eyelit for assistance.
• Approve eCHR - eSign Profile*: Signature profile that you need to close the eCHR.
• Reopen eCHR - eSign Profile*: Signature profile you need if you wanted to reopen a closed eCHR.
• Delete eCHR - eSign Profile*: Signature profile you need to delete an eSign profile.
• Printable Report Title*: The title displayed on the printable report.
• Languages: When you complete an eCHR, it generates reports in the languages specified here. Multiple languages are supported in the printable report.
• Separate eCHR per serial number toggle: This system flag determines whether a new eCHR should be created when a batch is assigned a new serial number through an edit or a split. When a new serial number is introduced, the system can either:

• Maintain a single eCHR for all related items.
• Create a new eCHR for the newly identified item, allowing for independent traceability.
• This also applies when you are starting multiple serialised items on a single job - you can add all items to the same eCHR or create a new eCHR for every item.

For more information, refer to the Splitting a Batch section below.

Edit an eCHR Profile

When you edit an eCHR Profile, you can only change the name. The rest of the configuration that was set up in the new eCHR Profile is contained in the eCHR Profile version. The versions are also editable when in draft status.

Edit an eCHR Profile Version

When you create the eCHR profile, the first version is automatically generated. When you edit the profile version, you can change everything that was configured in the New eCHR Profile (above) with the exception of the name.

Change Status

eCHR Profiles may have one of the following statuses: Draft, Pending Approval, Approved, Obsolete. To update a status, select the eCHR Profile version and click the Change Status button.

eCHR Profile Configuration

The eCHR Profile's no-code framework reduces the need for technical skills to implement. You can configure eCHR content in terms of what data is stored and how it is visualised through guided configuration tools. 

This provides you with the flexibility to configure regulatory data capture that matches your processes without customisation or complex technical configuration. It covers configuration of standard comprehensive data sets for Profile version headers but not additional / changed information in the datasets. For that, you would need Eyelit Services assistance. For more information, see Advanced Configuration.

Configure Data - eCHR Profile Header

The eCHR format is defined by its profile which controls how information is captured, formatted, and summarised. The Configure Data button (visible on the eCHR Profile menu when a version is selected) defines the header level summary (visible in the eCHR Listing page) which can be made up of fields such as profile name, recipe name, workflow name, version, and BOM name. 

The eCHR Profile Configure Data screen lets you configure how to display or hide a header detail in the website or printable eCHR reports.

The image shows how the profile version header information is displayed in the eCHR Listing page and the printable report.

eCHR Listing

Printable Report

eCHR Profile Configure Data

The data fields to be stored and visualised for each eCHR section lines can be configured through a graphical UI. The Configure Data screen lists the data points that belong to a profile. Each row represents one data field.

UI settings

The following settings can be viewed and edited for each data field:

• Order of data: Data points can be dragged / dropped to define the order in which they will be stored / displayed.
• Is Required: Mandatory inclusion in the eCHR. This field is read-only and indicates where a field is required for system functionality or regulatory compliance.
• Display: ‘Yes’ to include in the Detail section of the website / printable report.
• New Row: Define which information is on each line of the summary using the New Row toggle (e.g. workflow name and workflow version will be displayed on the same line of the header).

See Advanced Configuration which allows you to add customer-specific data, which is not covered in the no-code UI, to the blockchain.

Reset to Default

Select the Reload Default button to reset the default settings.

Edit Row

The Edit Row button displays when a header detail row is selected to open the Edit eCHR Header Config Data Point pop-up. 

Here you can:

• You can specify if the field is displayed and if it is on a new row or on the same row as the previous field.
• Change the Data Label in eCHR name. This is the name displayed in the header for this field.
• Specify the aggregation logic where applicable (e.g. list BOM slot candidates vs count of BOM slot candidates).
• Define which information is on each line of the summary using the New Row toggle (e.g. below workflow name and workflow version will be displayed on the same line of the header).
• Order the lines in the header (drag and drop in the grid).
• Access the advanced configuration via the Advanced View toggle. The Advanced View lets you modify the header data field, but this should generally not be required (contact Eyelit Support to assist with this if required).

eCHR Advanced Configuration (Profile Version Summary)

The standard configure options cover the visualisation of system supported data only, however sometimes there may be a need to add customer specific data to the blockchain. In this scenario, contact Eyelit Support and they can use the advanced function to add new information into the content of the blockchain record.  

Note that if the content is changed, the end user configuration tools are not supported, so full configuration of the contents and appearance needs to be done in Advanced Configuration mode.

Use advanced manual eCHR configuration only if a no-code option is available for the eCHR Profile version header, or if you want to customise the default data points provided by either the no-code or advanced configuration options.

To access the advanced configuration functionality:

1. Toggle on Advanced View in the eCHR Profile Configure Data screen (note that this toggle is only visible to users with advanced permissions - contact Eyelit support if you want to work with advanced settings).

The layout of the advanced config page is similar to the image below for all line types although additional fields may be displayed depending on the line type selected. 

In the Advanced View, the fields that you set on the no-code configuration screen appear in two HTML fields, one for the website report and one for the printable report, as shown in the following image. To choose what appears in the profile version summary, enter the details in the Website / Printable Report Details fields.

Splitting a Batch: Traceability and eCHR Implications

When manufacturing a batch, for example, of 100 units, there are scenarios where it becomes necessary to split that batch. This process can be handled in different ways depending on how traceability and record-keeping are to be maintained. There are three options.

1. Splitting Without Changing the Serial Number

If a batch is split but both resulting parts retain the same visual serial number, they are indistinguishable in terms of traceability. In such cases, a single eCHR must be maintained to represent the entire batch. This unified record ensures that all traceability data continues to apply to both parts of the split batch, as they are not differentiated by identity.

A practical example involves splitting a batch post-manufacture for storage in different locations. For instance, part of a batch may be stored in Location A and the rest in Location B. These would be treated as separate material items in the system due to their differing storage locations, but they would share the same manufacturing history. This scenario typically occurs after manufacturing is complete and does not necessitate a new eCHR.

2. Splitting With a New Identity

Alternatively, a batch can be split and assigned a new identity—for example, splitting batch “A” into “A” and “A1.” In this case, the new sub-batch (A1) can be given its own eCHR. The system allows for the history of the original batch to be copied up to the point of the split. From that point onward, the two batches (A and A1) can diverge, each maintaining its own independent traceability record. 

For example, you found a non-conformance with a result that a subset of the batch has to take a different path for rework. They will have different histories so you'll need to split them and give them different identities.

3. Maintaining a Single eCHR Across Multiple Items

Even when a batch is split into multiple sub-batches (e.g., A1, A2, A3), it is possible to maintain a single eCHR if desired. This means all traceability data continues to be recorded in the original document, which now applies to multiple items. This approach simplifies documentation but may limit the granularity of traceability.

For example, you have a manufacturing process where you are making a single batch and start producing things as a batch but the end of the process you serialise the items. In this scenario, you've got a single history record for the batch so although the items have individual identities, all the items have the same eCHR.

Note that if you serialise early in the process, you would opt for separate eCHRs for each serialised item.