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
For general information about the feature, see Compliance (KUMAVISION base). This article only describes the additional pages, functions, and fields available for it in medtec365.
Setup#
Compliance User Setup#
This page specifies the users who are authorized to manage compliance checks. 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 |
|---|---|
| Follow-up Assignment | Shows the content of the field with the same name in standard user setup. |
| Follow-up Team Assignment | Shows the team of reviewers that the user is assigned to (if available). |
| Follow-up Team Filter | Here you can set a filter on review teams if the user is assigned to more than one. |
Note
For general information about the feature, see Compliance (KUMAVISION base). This article only describes the additional pages, functions, and fields available for it in medtec365.
Compliance tables#
You can specify in these tables the changes to data records that approval is required for.
- 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 |
|---|---|
| Versioning | Select this field if you want items to remain available even while they are being modified. For more information, see Versioning Item Records. |
| Workflow Templ. Code | Only relevant to users who work with the Workflow and Notification Manager. |
| Workflow Templ. Version Code | Only relevant to users who work with the Workflow and Notification Manager. |
You can specify compliance requirements (=filters) for standard and additional fields per table. To set a filter on a field:
- Select a table.
- Choose Compliance Fields on the ribbon.
- Proceed as described in the following.
| Field | Description |
|---|---|
| Additional Field Code | Enter the code of a table field. |
| Add. Field Value | Specify the value that the entered field should be filtered for. |
If you don’t set filters, all fields of the table are checked with any change made to it. If you do, the system will run a check or create a compliance document if the values specified here do not match those given elsewhere in the system.
Note
For general information about the feature, see Compliance (KUMAVISION base). This article only describes the additional pages, functions, and fields available for it in medtec365.
Manage compliance#
For a better overview, medtec365 offers multiple role centers from where you can open documents relevant to your daily work, including a homepage that is tailored to the needs of compliance managers.
Trigger compliance#
Changing and releasing a record or completing data maintenance in a table will have the system check values based on the conditions specified on the Compliance Tables page.
Note
For general information about the feature, see Compliance (KUMAVISION base). This article only describes the additional pages, functions, and fields available for it in medtec365.
When versioning item records#
The use of versioning for item records means that you can continue to use an item after modification but prior to approval of the changes made to it. In this case, changes must be made to a copy of the item to trigger compliance. The source item is then updated with the release of the compliance document.