Sail Through Regulatory Compliance - Part 1

Posted by Kevin Sweeney on May 15, 2014 3:35:19 PM

 

Regulatory Compliance WorkflowWorkflow software is an extremely effective regulatory compliance tool.  Regulations require that organizations consistently, repeatably, and accurately follow standards and guidelines.  Regulatory agencies also require that organizations document their processes and verify that documentation is accurate and under revision control. Workflow software organizes, automates, and documents regulatory compliance processes.

Regulatory compliance represents a very large burden to many organizations: life sciences companies, banks and finance companies, insurance companies, food companies, universities, research laboratories, utilities, and many others.  Processes involving people and systems also require:

  • execution,
  • documentation,
  • review,
  • verification, and
  • electronic signatures.

With many different users and systems, with many activities involving branching and looping, with different levels of experience and training, and with potentially widespread locations being involved in processes, complexity can result in error, incomplete processes, loss of information, and enormous costs.  Using workflow brings these complexities and costs under control - and demonstrates that organizations are “in control” to the satisfaction of regulatory bodies.

Workflow works because the graphical design shows exactly what business step takes place in what order.  All users can agree on the flow of information and activities when they see it clearly drawn.  And the execution of a workflow leaves behind a graphical artifact that proves that instance of the process was executed per SOP.

In addition to the graphical artifact of the workflow execution, the data that was generated, used, or modified, including electronic signatures, is collected and stored automatically by workflow.  One smart approach is to use workflow to write that data, along with associated metadata, to a standard report: this report IS the review and verification documentation that complements the execution that workflow instance execution represents.

Taken together with compliant databases, the graphical artifacts and execution reports provide rock-solid evidence that organizational processes are in control - delivering to regulatory compliance professionals audit proof systems and assuring their companies much lower risk profiles.

Next week’s topic can be located here Sail Through Regulatory Compliance with Workflow Software – Part 2

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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Learn more about our Process Automation & IT, QA Services or Software Development products and solutions on the Web!  Visit us at: Innovative Process Solutions

Topics: regulatory workflow, regulatory compliance workflow, Blog, regulated environment, version control, regulatory compliance, workflow version control, workflow software