We are proud to announce that the TSG Compliance Solution now supports Periodic Reviews and Document Obsoletion. Both of these features are important for managing controlled documents, specifically Policies, Procedures and Forms. This post will provide a short explanation of these feature along with interface examples. Last, this post will also discuss ideas for potential future enhancements.
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 – The document does not require any updates, and the Periodic Review Date is reset to X years in the future.
- Revised – the document requires one or more updates. The document must be modified and then complete the review and approval cycle. Upon release of the updated revision, the Periodic Review date is reset to X years in the future.
- Obsoleted – the document is no longer needed and can be obsoleted.
To implement Periodic Review, the TSG Compliance Solution will automatically kick off a workflow task to notify either the author or a document control group that a document is approaching its periodic review date. This task is typically initiated 90 to 120 days prior to the document hitting the review date. The user or group receiving the notification can then determine what action should be taken on the document. They could also delegate the task to someone else for completion. If a user determines that the document is acceptable as is, the Periodic Review Date will be reset to 2 years (or a configured interval) in the future; the action will require an electronic signature and be logged in the document’s audit trail. However, if the user decides that the document needs to be revised or obsoleted, they will complete the workflow task and then follow the typical steps required to perform those tasks. Document Control can manage periodic reviews by performing searches to return all the documents back that are approaching their periodic review date or have overdue periodic review dates. By searching on all documents with upcoming and overdue Periodic Review dates (see screen shot below), Document Control can then contact the owners of the documents to confirm that they are indeed being reviewed and processed.
Additional advanced features that some clients also implement are discussed below:
- Automated Reporting – Provide the ability to automatically send Document Control an Excel-based report every 7-14 days, pushing information to this group rather than having them run the report manually.
- Automated Reminder Notifications – The system will send out reminder notifications to the end user to complete their periodic review task if the task is not complete by a specified time period.
- New Version with/without Periodic Review – Every time a document is versioned, the user may not perform a full review of the document. For example, a new version may be created to quickly fix some typos. In this process a full review of the document content was not performed. As a result, we may not want the periodic review date to be updated each time a new version is made effective. They would only want the periodic review date to be updated if the user specifies that a full periodic review was performed when creating the new version.
Checkout the Periodic Review functionality in action here:
Simple Obsolete functionality was implemented into the Compliance Solution as well. An action was enabled to allow specified groups of users to promote a document to Obsolete. This action requires a reason for obsoletion, an obsoletion date, and electronic signature. The electronic signature is recorded in the Document’s audit trail and on the document’s signature page. The user can specify the obsoletion date to be today or a date in the future. This allows the user to coordinate the document obsoletion with other changes (perhaps documents becoming effective that replace the obsolete document).
When the document is obsoleted, the system also provides for the ability to update the document security and the document overlay (using OpenOverlay). We find that many companies take these extra steps to restrict access to obsolete documents and prevent the read-only users from mistakenly using obsolete documents.
Check out the Obsolete functionality in action here:
Future enhancements to this functionality would be:
- Workflow -The ability to initiate a workflow (concurrent or sequential) to collect more than one signature (i.e. business users and document control) to approve the obsoletion of the document.
- Change Request – The ability to attach an Obsolete Change Request to a document when routing it for obsoletion. The Obsolete Change Request would describe why the document is being obsoleted and reference any new document that may be replacing it.