In the last blog post, we discussed how automated workflow demonstrates to regulators that your company follows its standard operating procedures (SOP.) Just as important to regulators is your ability to prove to them that you consistently followed your approved version of your SOP. Regulatory compliance mandates that you maintain a record not only of the documents and data that were created or modified, but also a record of the version of the process that your company uses to do these things.
Good workflow software offers version control of workflow designs. Version control means having a record of:
- saved workflow designs (automated SOPs) and
- each workflow that actually executed
With the right authorization, anyone in operations, quality, or even an outside auditor, should be able to review executed workflows and verify that they correspond to the workflow/SOP that was approved at that time.
Workflow software should include audit trails for both designs and execution. A record of who changed the workflow design and when, AND a report to show the difference between versions, makes it easy for employees, managers, and auditors to understand how your processes have evolved. And, being able to see who (or what system) created or modified information at each step in an executed workflow procedure creates an audit-proof trail for businesses for whom regulatory compliance is critically important.
Revision control, and the audit trails and reports that result from good version control, are mandatory in order to achieve compliant processes. Just as importantly, workflow software can be used to store the artifacts that are used and generated and consumed by processes. Workflow can check-in and check-out and create documents and records across and within a nearly limitless variety of document management, ERP, MES, and other enterprise systems. The records in these systems are typically maintained per codes such as 21CFR11, and audit trails exist within these systems that synchronize seamlessly with workflow audit trails. Together, these audit trails are the foundation for regulatory compliance.
Next week’s topic will be about how workflow significantly reduces the costs of regulatory compliance while simultaneously promoting continuous improvement.
Last week's topic was Sail Through Regulatory Compliance with Workflow Software – Part 1
You may also be interested in reading a previous blog post on the subject of Building Regulatory Workflow Solutions
A small sampling of the Workflow Technology for BPM Solutions contained within our cDevWorkflow product offering can be found here: Workflow Technology That Works.
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