iab
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Depends.

Us folks in NPD have very little interaction with it. When we ready a product for launch, we get all of the specifications, DFMEA, testing reports, design controls, etc at the ready and hand them off to a different group who actually inputs them into the PLM through an ECO. Those then get routed to get signoff by marketing, engineering, RA/QA, legal, regulatory affairs, etc. As soon as that becomes "baked", any changes are handled by everyone other than NPD (cost improvements, manufacturing process change, software, testing, etc). If NPD does want to make a change, again, we get the materials ready and they get inputted as a DCO. And again you need the proper signoffs before they can be released.

The signoff process is usually the most frustrating. Want to make a change to the the packing, label artwork? Or the IFU? We need about 20 signoffs. I'm not shitting you. If a comma is out of place, and expect that on your first submission, your DCO will get rejected and you get to go through the signoff up to that point again. It's especially awesome when the 20th signature rejects the DCO.

I should mention that we are a medical device company and our documentation process is more rigorous than most. We are also mostly class 1 exempt devices with a few class 2 and drugs thrown in there. And the FDA and the EU requirements for class 1 are less than class 2. Unfortunately for us, we were acquired by a company that lives in the class 2 and class 3 world. They want us to complete the class 2 requirements for class 1 devices. That is currently an ongoing negotiation where it does not look good for those who believe in less paperwork.

If I were to estimate, figure a day to get the launch package submitted as an ECO. Your signoffs will depend on the structure you create. Ours can take 1-4 weeks, depending on how hard you birddog the process. A DCO or ACR takes minutes to a couple of hours, depending on complexity to create. Signoffs can be quicker, but that depends again on who is needed to sign. You really need to manage the signoffs. Less is better than more. Don't let politics drive who is on the list, it will doom your software to failure.
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Mr-914
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It was described to me as this automated emailer that was going to SPAM me tasks that needed to be done everyday. I could have misunderstood and it is was the sign off process that was being described.

I agree with you about less signoffs, the better. I'm working on decorative lighting, so I feel like nothing should require more than 2 signatures. I'm sure others will disagree:)
Ray Jepson

"The key to success in this business is to find a boss who doesn't care." - Mike Rowe
Sharpinside_Web
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i am working with surperior group and we use oracle for any new product development
CRVaughan
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Another Agile user here, and I pretty much agree with iab's feelings on the subject. Last year we finally upgraded from Agile 2006! Luckily, we don't have as exhaustive an ECO process, but it still takes a while. The time suck for me is when I have to convert all files to an ECO-friendly format, then submit for approval, then make changes before the ECO gets signed off. Luckily, I've been able to automate a lot of the tedious stuff with scripting in Illustrator and Solidworks. Learning to "Save as" ECOs was also a big time saver.

The big hang ups for my company are when we are waiting on compliance approval - Files can be ready for the factory but not approved for release for up to (or more than) a month!

Overall, it's a pretty easy concept to grasp -
Sharpinside_Web
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windchill is may be the good option for you.
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Mr-914
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I've found waiting for approval without a PLM software is just as long and frustrating a process.
Ray Jepson

"The key to success in this business is to find a boss who doesn't care." - Mike Rowe
whitecom
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Joined: December 14th, 2017, 4:29 am
I have found an white paper about Product Lifecycle management, here is the link: https://www.ciowhitepapersreview.com/ae ... a-730.html
Developer_App
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Joined: January 3rd, 2018, 4:59 am
Product lifecycle management (PLM) is a business system that provides control of the product record across all development stages—from concept to design to production. With a PLM system in place, a company can manage product data including items, bill of materials (BOMs), and approved manufacturer lists (AML) and product files.
Enterprise resource planning (ERP) is a business system used to manage financials and reporting around activities such as accounting, sales forecasting, manufacturing planning and execution, customer care and support and shipping logistics.
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