Writing SOPs for Software Process Validation
Ensuring Line-by-Line Project Compliance and Traceability

The FDA is training legions of new investigators who’ll be going through your code line by line, looking for flaws that lead to 483s and warning letters. But you can avoid getting snared in the FDA’s net. Read on ...

A battalion of new FDA investigators ― just out of the nations top computer science programs ― are ready to hit the streets.

Do your SOPs accurately reflect real-world life cycle and workflow processes? Are you actually following your own defined processes and SOPs? The answers had better be “yes” ― because the FDA is ready with new sanctions.

No need to fret, though. You can prepare yourself and your staff for this new wave of scrutiny the easy way. Just log on to the webinar from FDAnews. In 90 minutes, you and your staff will learn what you need to know ― without ever leaving your desk.

We’ve signed up a leading software quality expert, Eric Henry, who’ll show you:

• How to create templates for software projects to assure that work processes match up to SOPs. These templates can serve as traceability documentation during FDA inspections.
• Two tools to keep software development projects in compliance and on schedule:
  • Flow Steps Plan (FSP), a software process development tool to create SOPs, refine project templates and execute project activities
  • Work Breakdown Structure (WBS) to define each task in a software project and help organize and define resources needed for each step

Via a case study, you’ll participate in an ISO audit of a company software engineering process, including specifics ― how the auditor asks for explanation of the workflow within the software SOPs. At the end, the example company produces a WBS to prove it is complying with its documented processes.

You’ll learn how to use the FSP method to tie processes to project plans and schedules ... ensure process relevance in the real world ... plot processes on a workflow map ... create software project documents that combine process traceability and accountability ... use software validation to provide evidence of SOP compliance to auditors ... and accurately estimate project times and resources, potentially saving your company millions of dollars.

It’s 90 minutes of information-packed learning — a totally interactive web-based session with ample opportunity for all your questions. Just email them in during the session. You’ll have your answers by the time you log off.

All too often, companies neglect the link between process workflow, actual process and project activities. This presentation shows how to avoid such pitfalls in your organization, developing software engineering processes that deliver audit-worthy evidence that your process reflects your needs and SOPs.