Using SpiraPlan for GxP CFR Part 11 Projects

January 28th, 2021 by Adam Sandman

We're very excited about the upcoming release of SpiraPlan 6.7.1 for both our cloud and on-premise customers. In addition to the powerful new tools for developers and DevOps engineers, we also have some new document management enhancements that will be amazing for customers working in the life sciences, especially on GxP projects that have to follow FDA / EMA rules such as 21 CFR Part 11.

SpiraPlan Workflows and Electronic Signatures

As you may know, SpiraPlan already has powerful workflows for managing requirements, test cases, releases, tasks, defects and risks that allow you to require electronic signatures when you move a requirement, test case, etc. from one status to another. This lets you manage your GxP approvals and processes at the artifact level so that you can manage all the items scheduled for a release and make sure that they have been approved and validated. Our recommended approach is to manage the artifacts in SpiraPlan, approve the artifacts in the system (as the source of truth) and then generate the various documents you need from these approved artifacts.

With our new baselining feature, you can even track all of the changes in a release and then have approvals, validation and signing for the entire release.

However, many of our customers are coming from the world of requirements documents, test case documents, and functional risk spreadsheets. This means that their processes have been built around generating documents and then having their stakeholders approve the documents. When implementing an electronic requirements and test validation system such as SpiraPlan, change management is often the biggest hurdle to adoption.

Document Approvals and Electronic Signatures

So we have added some new features in 6.7.1 that lets you maintain this document-centric way of working for some or all of your projects instead. In this model, instead of managing the electronic signatures on the individual SpiraPlan artifacts, you can use SpiraPlan to generate the documents from the Report center and then manage the sign off and approvals on the documents themselves.

Setup Document Workflows

The first step is to configure your Document workflows to have the appropriate steps and transitions. For example:

Make sure that any of the review steps that require an electronic signature have that setting enabled:

Once that is done, you can the create Document folders (and types) for each of the types of controlled document that you will be routing for signature in SpiraPlan:

Generating Reports and Saving as Documents

Now that you have everything setup in the documents management module, you can use the requirements, test case, risk and defect modules in SpiraPlan as you would normally. Since the approvals and e-signatures will be done at the document level, you will not need to have electronic signatures enabled in the requirement and test case workflows.

At the end of the appropriate release, you can now go to the Reports center and generate the various documents that you need to route for approval and e-signature. These could be our standard SpiraPlan reports or customized ones:

The key step is to make sure you check the box to save the generated report into the Document Management system and specify the correct folder:

Once the report is generated, the document will be automatically saved into the appropriate folder in SpiraPlan:

and similarly:

Now that the reports have been saved as documents, you can use the Document workflows that we setup earlier to handle the routing and approvals.

Approving and Signing the Documents

The documents will be stored in the document management system as 'Draft' documents. You will now be able to click on the document and assign it for the first approval:

Once saved, the user (in this case Fred Bloggs) will get an email letting him know that the document needs review. When Fred goes to his My Page, he will be able to click on the link to do the review: