Compliance#
Overview#
The Compliance functionality helps you design processes that can fulfil regulations such as FDA 21 CFR 11. It supplies, for example, the operational system checks you need for properly certifying BOMs and routings, releasing items, vendors, customers, and validation plans, and providing feedback on manufacturing operations.
You can specify individual regulatory requirements through table and field filters. If, following a change in data, you want to re-release a record that must meet some of those requirements, a compliance document will be generated. This document then needs to be approved by certain staff members prior to release.
Note
You need a separate license before you can use this functionality. If you’re working with KUMAVISION medtec365 and the Workflow and Notification Manager, you can also specify a workflow for handling approvals.
Note
If you’re working with KUMAVISION healthcare365 and the Workflow and Notification Manager, you can also specify a workflow for handling approvals.
Setup#
Compliance Setup#
To set up compliance management:
- Choose the Search icon, enter Compliance Setup, and then choose the related link.
- Fill in the field as described in the following table.
| Field | Description |
|---|---|
| Compliance Nos. | Specify the number series that you want to use for compliance documents. |
| Legal Owner or Possessor Reqd. for Rejection | Turn on this toggle if you want only the user who created a compliance document to be able to reject it. With the toggle turned off, all users who have the relevant compliance permissions can reject the document. |
Compliance permissions#
Individual permissions#
You set up permissions for users to specify who will be involved in each step of the compliance process. To set up a permission:
- Choose the Search icon, enter Compliance Permissions, and then choose the related link.
- Choose New on the ribbon.
- Fill in the fields on the new line as described in the following table.
| Field | Description |
|---|---|
| Code | Enter a meaningful code to identify the permission. You can later assign this code to a permission group. |
| Description | Enter a brief text to describe the permission. |
Permission groups#
Individual permissions can be grouped before being assigned to a user authorized to manage compliance checks. To set up a group:
- Choose the Search icon, enter Compliance Permission Groups, and then choose the related link.
- Choose New on the ribbon to insert a new line on the page.
- Fill in the fields as described in the following table.
| Name | Description |
|---|---|
| Code | Enter a meaningful code to identify the permission group. |
| Description | Enter a brief text to describe the group. |
To add individual permissions to a group, fill in the Code fields on the Lines FastTab.
You can then enter a maximum net amount that values entered on purchase or sales documents will be checked against. If a value you specify is exceeded, the document can no longer be released. Should you also require minimum amounts for multi-level approval processes, you can enter them in the relevant Compliance Tables.
Compliance User Setup#
This page specifies the users who are authorized to manage compliance checks. It also contains all digital signatures for case-related functionality. To set up a user for compliance procedures:
- Choose the Search icon, enter Compliance User Setup, and then choose the related link.
- Choose New on the ribbon to insert a line for a new user.
- Fill in the fields on the line as described in the following table.
| Field | Description |
|---|---|
| User ID | Specify the user for whom you want to add a signature. |
| Salespers./Purch. Code | Shows the code from the field with the same name in standard user setup after you’ve entered an ID. |
| Digital Signature | Enter the digital signature of the user. |
| Signature Blocked | Turn on this toggle if you want to block the user from using the entered signature. |
| Signature Fail Count | Shows the number of times the user has entered the wrong digital signature. |
| Signature Blocking Reason | Shows why the digital signature was blocked. |
| Reset Signature | With the toggle turned on, the user’s digital signature needs to be updated before another attempt to enter it can be made. |
Note
If you’re using KUMAVISION medtec365, you can assign follow-ups at this point. For more information, click here.
Assign permission groups#
Any number of compliance permission groups can be assigned to a user. What the user is authorized for is covered by the individual permissions assigned to a group. For example, if permission A is required for a certain compliance table, the user must have this permission according to at least one assigned permission group. To assign a group:
- Choose the Search icon, enter Compliance User Setup, and then choose the related link.
- Select a user on a line.
- Choose Compliance Permission Groups on the ribbon.
- Fill in or change the group. If you change it, choose OK to confirm.
Compliance tables#
You can specify in compliance tables for which records a check for compliance is required. To set up a table:
- Choose the Search icon, enter Compliance Tables, and then choose the related link.
- Choose New on the ribbon.
- Fill in the fields on the new line as described in the following table.
| Field | Description |
|---|---|
| Code | Enter a unique code for the data record. |
| Table No. Table Caption |
Specify a table for which you want to check compliance. Note Some tables have subtables that might become part of the compliance check. |
| Sorting | If the system finds multiple entries that differ in their field filters, a record might be subject to more than one release requirement. You can then use this field to specify the order in which to check entries in the table. The sequence is always ascending. |
| Description | Specify an internal description for the table. |
| No. of Field Filters | Shows how many requirements must be fulfilled before the table is said to be compliant with the relevant regulation. You specify a requirement by choosing Compliance Fields on the ribbon. |
| Status | Indicates if the table is part of the compliance process. Only in the Released status will a compliance rule that you specified on the line be applied throughout the system. |
| Minimum Amount | You can use this field to specify an amount limit on purchase and sales documents. If this amount exceeds the total net value entered on the relevant document, approval will be required. |
| Signature Required for Release | Select this checkbox if you want each compliance release verified through the digital signature. |
| Change Permission Code | Choose the code that permits changing the record. This will start the compliance process. |
| Release Permission Code | Choose the code that permits release of the record. |
| Reject Permission Code | Choose the code that permits rejection of the record. |
| Release 1-5 | Select the releases, that is, approvals required for the record. You can have up to 5 levels of approval. |
| Release 1-5 Permission Code | Select the permission codes for releases. |
Note
If you’re using KUMAVISION medtec365, you’ll see additional options on this page. For more information about them, click here.
You can specify compliance requirements per table. To set a filter on a field:
- Select a table.
- Choose Compliance Fields on the ribbon.
- Fill in the fields as described in the following table.
| Field | Description |
|---|---|
| Field No. Field Caption |
Specify the number of a field available in the selected table. |
| Field Value | Specify a value for the field. |
If you don’t fill in these fields, the entire record will be checked. This means that any change to the table will trigger a compliance check.
If a field value has been specified, the system will check whether this value matches the field value in the relevant table. Only then will it trigger a compliance check or set up a compliance record.
Note
If you’re using KUMAVISION medtec365, you’ll see additional options on this page. For more information about them, click here.
For example, you might want to monitor the tracking code field of a certain item. The current value in the field is BE. You now change the code to NL, which will generate a compliance document.
Or you might want to track changes to the Quote document type. The data records to be monitored have already been filtered based on the Buy-from Vendor field, with the filter set on a specific vendor. When a quote is later created for the vendor, a compliance document will be created as well.
Note
Only if a data record meets at least one of the specified requirements will the system create a compliance document. Also, filling in a table that has subtables might mean that they, too, will be checked for compliance. You can see the relations to subtables on the Compliance Tables page by unhiding the Subtable ID Filter.
Audit trail (change log)#
The Compliance functionality only logs the time when a compliance record was last modified and the ID of the user who modified the record, whereas the content of the changes made to checked data are listed in a log called an Audit Trail.
However, you first need to set up this change log for—at least—the tables entered on the Compliance Tables page. To set up a log:
- Choose the Search icon, enter Change Log Setup, and then choose the related link.
- Alternatively, enter Compliance List, select a data record, and choose Report > Audit Trail. You can also select an open or archived record and then choose this function.
- On the Change Log Setup card, turn on the Change Log Activated toggle.
- On the ribbon, choose Tables and select the table for which you want to set up an audit trail.
- In the Log Insertion, Log Modification, and Log Deletion fields on the line, you can specify if the log should include changes to some or all fields.
- To specify the exact fields when selecting the Some Fields option, choose the Assist button next to Log Insertion, Modification, or Deletion to open a list of all fields in the relevant table. Depending on the log function you selected, you can then choose Insertion, Modification, or Deletion on the relevant line.
Afterward, you can choose Audit Trail in open compliance records or the compliance list to see all changes that must be released, whereas the Compliance List Archive—and archived compliance records in general—also include changes made previously.
Manage compliance#
Trigger compliance#
Changing and releasing a record or completing data maintenance in a table triggers a check for compliance if one of the conditions specified on the Compliance Tables page is met.
Following the change, you need to give a reason for why the data record needs to be released again. You can also enter a longer explanation of the change via a separate text field if necessary. After you’ve entered a reason, the system informs you that the record can only be released after the changes have been approved.
You can see the status and history of compliance procedures related to the record in the Compliance FactBox on the right.
Edit a compliance document#
To see a compliance document:
- Choose the Search icon, enter Compliance List, and then choose the related link.
- This opens a list of all documents with open compliance procedures. Select a record and choose Manage > View on the ribbon.
Document approvals#
Document releases (that is, approvals) are handled based on how you’ve set up the approval process for compliance documents. To release a document:
- Select the approvals in the Approvals area and choose Release on the ribbon.
- Depending on the release option you chose for the relevant compliance table, the system might now ask you for your digital signature.
Note
When all approvers have released the compliance document, the source document is also released.
Following approval, the compliance document will be closed and archived.
Reject a document#
To reject a document:
- Select a record and choose Reject on the ribbon.
- Enter a reason for the rejection. You can also enter a longer explanation in a separate field.
Following rejection, the compliance document will be closed and archived.
Note
Based on what you specified in Compliance Setup, only the legal owner or possessor of a piece of equipment might be able to reject a compliance document covering the machinery. The user who wants to reject the document must also have been granted the necessary compliance permissions.
Audit trail (compliance card and list)#
If you set up an audit trail, you can see a log of all changes by running the Audit Trail function on the card or list ribbon. The basis for this trail is the change log you set up as described earlier (see Audit Trail (Change Log).
Compliance List Archive#
To view already completed compliance documents, choose the Search icon, enter Compliance List Archive, and then choose the related link.
The page that opens shows you two sets of records, the released and the rejected compliance documents.