FDA Compliant Company - which procedure addresses Customer Order Changes/Requirement?

M

maxwell

Greetings:

In a FDA compliant company, what procedure does one address customer requirements, Specifically changes to customer orders.

Thanks
 
A

Aaron Lupo

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

If you are asking where does the CFR address contract review it would be under 820.160 part a. If you are asking which internal procedure that is up to you, however, if you have one that deals with order/contract review that would be a good place to start.
 

Ajit Basrur

Leader
Admin
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 ?
 

Scott Catron

True Artisan
Super Moderator
Re: FDA Compliant Company - which procedure addresses Customer Order Changes/Requirem

The original poster didn't specify, but the drug GMPs (21 CFR 211) don't address contract review.
 
M

maxwell

Re: FDA Compliant Company - which procedure addresses Customer Order Changes/Requirem

Greetings:

Let me clarify my company is a medical device manufacturer of class 1 medical devices. Our QMS (CFR 820) system is FDA compliant. I am trying to determine where it is best to address changes to customer requirements, I am thinking contract review though I do not see a rerquirement for a contract review procedure. The other option I see is in the quality manual, I am wondering how fellow cove members have addressed this.

Thank You
 
A

Aaron Lupo

Re: FDA Compliant Company - which procedure addresses Customer Order Changes/Requirem

Greetings:

Let me clarify my company is a medical device manufacturer of class 1 medical devices. Our QMS (CFR 820) system is FDA compliant. I am trying to determine where it is best to address changes to customer requirements, I am thinking contract review though I do not see a rerquirement for a contract review procedure. The other option I see is in the quality manual, I am wondering how fellow cove members have addressed this.

Thank You

As has already been mentioned look at 820.160 part a it states “Each Manufacturer shall establish and maintain procedures for control and distribution of finished devices.......and that purchase orders are reviewed to ensure that ambiguities and errors are resolved before devices are released for distribution."
 
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