MadCap Software Forums

I'm reaching out to anyone here who may have been asked to prove that content that is output in PDF will be the same in HTML.

Background: Reviewed, approved, and verified content is released in PDF. We want to offer that approved content in HTML 5 also. The FDA wants assurance that the content will be unchanged when we output as HTML. We must test and prove that Flare does what we know it does.

Anyone with experience to share, I'd love to hear from you!

Trish Edwards
Principal Technical Writer
Medtronic Global Service Organization

Hi Trish

My client has similar requirements (medical equipment). The company met this requirement by validating the doc tool (not Flare). This was just as you indicate: to test and prove that the tool behaves as intended and as expected. The company is global, so they had a lot of experience from their validation and verification department to draw on - I expect you have the same? The validation test was done in-house, and it covered all aspects of the software from technical stuff (installing, starting up, logging in) to functional stuff (creating a topic, saving a topic, editing a topic, applying a condition, publishing a topic to PDF, output a topic to HTML5 - are the results the same?). Fault-handling was also tested, e.g. loss of network connection. Evidence was provided at each step (screenshots). The whole validation spec was split into several tasks to make it easier to handle. The spec was then signed off and the requirement was complete. It is important to set the parameters of the spec, such as whether upgrades constitute a new tool that needs to be validated again. I expect your validation department can advise on that.