In Formwork, documents can only be released through a review. Once you're ready to send a document for a review, click the "Send for a Review" button in the top right corner of a document.

In most cases you will be greeted by the Enjoying Super User Mode screen:

Formwork asks you to re-enter your login credentials in certain situations. Typically, this is when you want to send out a document for review, or when you want to sign a document electronically, or when you want to make changes to company-wide settings in Formwork. We call this "Superuser Mode".

Once you have successfully re-entered your login credentials for Formwork, you will see the review form:

In the review form, your task is to optionally describe the changes you recently made to this document to give your reviewers some hints at what they should look at - and more importantly, you need to select reviewers too.

There are a few important notes to keep in mind about selecting reviewers and the review process:

• Self-review: In small companies, it has been our experience that it is also possible to review your own documents. In that case, you would select yourself as a reviewer - this is in line with the ISO 13485, which considers document review under risk-based approach, and has also been confirmed by auditors.
  You can enable or disable so-called self-review in the Formwork settings by clicking on your name in the top right corner and heading over to settings.
• In the "Select Reviewers" field, you actually enter roles and not the names of people. So, for example, you would enter the roles CEO and regulatory consultant instead of the actual people, for example Oliver and Sebastian. In our experience this is a much more pragmatic approach as it enables your company to remain operational even when e.g. someone goes on vacation (and the review would get "stuck").
• One role can include multiple people, but it is sufficient for one person per role to sign off on the review. So, for example, if you have the role CEO and it has only one person, and you send out the document for review by this CEO role, then that one person has to sign off for the document to be released. No one else can sign off on the release of this document because the role only has one person. This is a good setup for certain roles where you really need a specific person to sign off. On the other hand, if we have a role named software developer which consists of two people and send out a document review to this role, then it is sufficient if only one of those two software developers signs off.
• You can send out a document review to one or many reviewers (roles), and all roles have to sign off. So, if you send out your document to the roles CEO and software developer, then of each role at least one person has to sign off for this document to get released.

Rejected Reviews

• Keep rejected reviews: A rejected review is stored as a separate version in the document in Formwork, and you can look at it later at any time to see, for example, why the document was rejected.
• Don't keep rejected reviews: A rejected review is not kept around, so your version history of each document in Formwork only includes the versions which have successfully passed the document review process.