See how the Compliance Solution works from start to finish
In the TSG Compliance Solution Demo Series, we look at how the solution is used to control documents in a real-world scenario. Let’s say we want to make a change to a Standard Operating Procedure (SOP). How do we go from making the change, getting it reviewed and approved, and making the change effective? What about when the document needs to undergo Periodic Review or be made obsolete? Watch the demos to find out!
Demo #1 – Search
The first step is to search for the document we want to modify. In this demo, see how users search for and view documents in HPI.
Demo #2 – Edit Document
Now that we’ve identified the document we want to change, watch this demo to see how users edit documents in the system.
Demo #3 – Create Change Request
Changes to controlled documents are not reflected to end users in the system right away. A Change Request (CR) form is needed to describe the change and allow for review and approval processes to ensure the proper signatures are applied to the document. In this demo, we are attaching the updated SOP document to the form and routing them both for approval at the same time. Some businesses do this a little differently where the CR is routed first, and then the document is routed on a separate form. The TSG Compliance Solution supports both approaches.
Demo #4 – Route for Review
Typically, CR forms go through a review process before they’re routed for approval. This process gives reviewers the chance to make changes and comment on the CR form and/or documents through TSG’s OpenAnnotate product.
Demo #5 – Approve Change Request and Document
During the approval process, the form and document are locked down while approvers add their 21 CFR Part 11 compliant eSignature to the documents. The TSG Compliance Solution leverages the Active Wizard’s dynamic workflow module. This allows for a flexible workflow solution that can be configured for many different business process scenarios and can also change over time without getting IT involved to update the system.
Demo #6 – Making the Change Effective
Once the change has been approved, most business processes have a training period before the document is made effective. See how a regular user in the system can view the approved version during the training period and how the document is made effective, rendering the previous version inaccessible to the user.
Demo #7 – Periodic Review
Periodic Review is a typical regulatory requirement that documents be reviewed every X years, typically every 2 years. A company needs to track that a documents have been reviewed according to this schedule, and reviewed documents are either determined to be Acceptable as is, Needs Revision, or Obsolete.
Demo #8 – Document Obsolete
When a document is made Obsolete, it is no longer accessible from the system except by a select few users. Documents are made Obsolete when they are no longer used or have been replaced by one or more new documents.