e-SOP Process Automation

JobRouter e-SOP: Process Automation and Life-Cycle
Management for Standard Operating Procedures

e-SOP System Overview

The eSOP system is, at its core, an electronic process that manages SOP document life-cycles including the creation, review, approval and release of documents, as well as the distribution and archiving.

The systems has been built upon the following software components:
• JobRouter® as a Business Process Management (BPM) system
• JobArchive, the JobRouter add-on module for Electronic Document Management.

For creating and editing new SOPs the system integrates:
• Microsoft® Word as word processing software

Electronic signatures are supported for approval and release of documents according to FDA 21 CFR Part 11.

e-SOP Process Flow

The JobRouter workflow system functions as the primary user interface and is accessed through Web browser. As most users are familiar using Microsoft Word for word processing, the system integrates Microsoft Word for editing new SOPs.

e-SOP Process Workflow controlled by JobRouter BPM Suite

Creating and editing documents

Document editing through the eSOP system is limited to a defined group of users called Creators. The documents are created on the basis of master files. Master files are stored in a document archive as versioned templates in Microsoft Word format.

A new document life-cycle begins when a creator chooses a template or an existing document as the basis of a new document. A copy of the selected template or document is provided to the creator to create and edit the content. Editing can be done in multiple phases, the user can always store the interim work. Once the creator has completed editing the work, the documents is submitted for review using the eSOP user interface.

Reviewing documents

Any number of users can be assigned as reviewers of the submitted document. Each reviewer will be notified by e-mail that there is a document that requires their attention. The user can view the document or choose to open and edit any documents that he or she was designated to review.

During the review process, the creator has the ability to monitor, evaluate and even edit the document contents. During the review phase, the creator also has the option of withdrawing the document. In case the document is withdrawn, the review request would be removed from any reviewer’s task list.

After evaluating a document, every reviewer is required to mark the document with his or her evaluation concerning the correctness and completeness of the contents. Only after all reviewers have evaluated the document as “Correct and Complete,” the creator allows the process to continue to the Approval step.

Approving and releasing documents

The approval step is two phased: The appointed Approver is responsible for the completeness and correctness of the contents. After the Approver has reviewed the document, he or she will approve or decline the document: the approval will be issued by entering an identification code and password.

The second phase of the approval process is the release of the approved document. A user or group of users will be notified that a new document has been approved and a request for release will be sent to their task list. The second phase approvers will release and sign the document by, also, entering an identification code and password. The final SOP document will have a cover sheet with the electronic signature representations including the user names and timestamps of review, approval and release.

Once the approval and release is completed, the document will be available to a predefined distribution list and the status of the document will appear as “Released” in the “Distribution” queue of the eSOP system.

Members of the distribution list will receive a request to confirm that he or she has received and read the documents. Those user confirmations are automatically stored as PDF documents in an electronic document archive for review by system administrators.

Managing the validity of documents

Typically, documents in the eSOP system contain an expiration date. System workflows will notify the document owners that the document will expire and a review of the contents will need to be performed. The document owner will then have the option to request a validity extension, withdraw the document, or submit it for review as a new version.