Re: FDA Compliant Company - which procedure addresses Customer Order Changes/Requirem
Greetings:
In a FDA compliant company, what procedure does one address customer requirements, Specifically changes to customer orders.
Thanks
To add on to what Aaron has rightly mentioned, the customer orders have to be changed as per your internal procedures - it may be manual or by ERP systems such as SAP etc.
Just remember certain key elements of this process -
1. How are these change orders obtained from customer ? If they are verbal, how is it documented subsequently ?
2. Are work instructions / procedures in place to address change orders ?
3. Is the ERP system validated as per 21 CFR Part 11 ?
4. How is information about order changes communicated to relevant departments/personnel within the company?
5. Are people trained on this procedure ?