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Subject:Document Change Order-- Process (a.k.a .ECO) From:Lynda Shindley <LShindley -at- ANGEION -dot- COM> Date:Fri, 22 Aug 1997 10:44:17 -0500
The medical company I work for is ISO certified and of course we are regulated by the FDA. We have an extremely cumbersome Document Change Order (DCO) system. It takes weeks, sometimes months to get a DCO through the system. One part of the process holds up another part. Every time we (the writers) release a document, we go through a new song and dance. The new rules just appear on the spot. We seem to be responsible for a large amount of paperwork. We encounter much confusion, and we spend too much time tracking down 20 people to provide information and signatures needed for the DCO. I could give you many examples, but it would take up too much of your reading time. Instead, my partner and I have compiled a list of questions in the attachment.
You may send email directly to me, or post on the list if this is an acceptable topic and of interest to other writers. We are just wondering what the technical writer's role is in the DCO process. And, does anyone have a consistent, logical system in place?