Re: Engineering Change Request/Order (ECR/ECO) or Document Change Request/Order (DCR/
I work for a medical device contract manufacturer and am struggling with this exact same issue... they want to use one form to capture all documentation changes. One thing I have not seen on any of the forms that I have been looking at on this site is one that would be specific to a meddev company--i.e. would capture review of risk analysis, validation, inventory, training requirements, customer notification.... can anyone out there help with examples? I'll share an example of what I have as soon as I finish it, but any help now would be greatly appreciated.
You all are the best!
I work for a medical device contract manufacturer and am struggling with this exact same issue... they want to use one form to capture all documentation changes. One thing I have not seen on any of the forms that I have been looking at on this site is one that would be specific to a meddev company--i.e. would capture review of risk analysis, validation, inventory, training requirements, customer notification.... can anyone out there help with examples? I'll share an example of what I have as soon as I finish it, but any help now would be greatly appreciated.
You all are the best!