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In addition to developing software products, our company manufactures test and
simulation equipment for medical equipment. As such, we're subject to FDA
regulations regarding labeling. Labeling includes the actual label on the
product and any documentation that accompanies it. For this reason we are
required to track manual revisions through the ECO process.
I try to remove myself from handling the ECOs because since it's part of the
product I figure that it's a responsibility of the project manager/engineer.
Besides that, I was hired to develop new product content and not to chase ECO
paper trails. My condolences to you if you have to deal with this.
Folena, Shannon wrote:
> I'm curious as to how many technical writers work with Engineering
> Change Orders (ECOs).
> I've been in the healthcare industry for the past four years and had
> never heard of ECOs. Now, I'm in a new industry and am discovering the
> wonderful world of ECOs. I'm in awe of all the time-consuming rules and
> paperwork involved. For instance, when I revise a document, I have to
> write down on the ECO what each sentence was before and what each
> sentence now says -- "is" and "was" statements.
> I'm wondering if ECOs are common place, or if I've been blissfully
> Shannon Folena,
> Technical Writer
> C&K Systems, Inc.
Senior Technical Writer
DNI Nevada, Inc. mailto://hermet -at- dninevada -dot- com