Guest blog post by Rina Nir of RadBee

When considering using Confluence to develop and release controlled documents, one of the main concerns many companies have is whether they will be able to approve the documents directly from the application.  This is possible using Comalatech’s Comala Workflows plugin, which allows us to configure your desired approval workflow right into Confluence.

This plugin has the two key components required for FDA CFR 21 Part 11 compliance:

  • each approval step can be linked to an electronic signature
  • each approval activity is logged in a dedicated page activity report, creating an audit trail.

 

This makes it suitable for the controlled document process in organizations that need to adhere to good manufacturing practices (GMP) and other stringent regulatory frameworks. Figure 1 below shows a screenshot of an example report.

Figure 1: Page activity report

Deciding on the approval process

Once the Comala Workflows plugin is installed, you’ll need to decide on the approval process you want to use. Many teams don’t have a formally defined approval process until they decide to manage their controlled documents in Confluence. Until then approval often depends on various people adding their signature to a final draft once it has been reviewed.

In fact the informal review phase leading up to final approval is often very important, making it possible to incorporate the feedback of many stakeholders. Fortunately a variety of collaboration features built into Confluence facilitate this.

Installing the Comala Workflows plugin makes it possible to follow the informal review with a formal review and approval phase, where approval and electronic sign-off are logged on the system. This stage can replace your existing paper or electronic sign-off.

One of the interesting aspects of the plugin is that it makes it possible to apply different review and approval processes to different controlled documents, using a single workflow definition. This is helpful, because some documents by nature demand a more complex approval process than others. Obviously, it’s also possible to define several separate workflow scripts to use in different cases.

Below is an example of the code involved in an approval workflow, which demonstrates many of the features available. First, figure 2 shows a brief overview:

Figure 2: A scheme of how an approval process for controlled documents can look like.

Approval workflow example:

A full blown example of an approval workflow is provided here (link to: http://www.radbee.com/using-comala-workflows-for-approval-of-controlled-documents/)

Some key points about the example workflow

The role of ‘Author’ and the review process

‘Author’ is a workflow parameter. When a document is created, the role of Author is assigned to the user who created it, and is reassigned every time someone moves the page back into draft status. So, essentially, any person initiating a change becomes responsible for taking the document through to approval (see lines 81 etc). The Author can edit a document without causing it to revert to draft. They may also choose to revert a page to draft by manually approving a ‘Revert to draft’ (see lines 201 etc.) Only the Author has the permission to edit a page while it’s in review (see lines 176 etc).

Note that, for edit restriction to work properly, the configuration parameter of ‘Space Tools > Workflows > Configuration tab > Workflow Activity and Drafts Visibility’ needs to be changed to ‘Anybody’.

Use of workflow parameters to control the review and approval process

  • The identity of the default ‘QA approver’ – the person who needs to approve a document – can be changed for each document using the relevant workflow parameter.
  • Approval by ‘QA approver’ is obligatory, but only certain documents will need additional approval. In order to simplify the approval process where appropriate, you can just change the ‘Who needs to approve’ setting (see line 93 etc).
  • If training is required before a page can be published, you can set a fixed delay within intermediate status, using ‘Approved and pending training’ (see line 66). In the example we’ve set a delay of two minutes, but in reality this can be set to a week or more, as appropriate. Whether the delay happens or not will depend on the workflow parameter ‘Training’, which can be set to ‘Required’/’Not required’ (see the triggers in lines 85 etc).

Figure 3: Using workflow parameters to influence the approval process.

Email notifications

Emails are sent automatically:

  • to participants when their action is required (see lines 110 etc)
  • and to the Author when the status of a document changes or when another user approves or rejects one of their documents (see lines 130 etc).

Getting Started

For more details, you can refer directly to our Comala Workflows Documentation on using the plugin, or send us an email.
If you would like assistance with implementing a controlled document approval process using Confluence and Comala Workflows, please get in touch with RadBee directly.

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