Change Management Procedure

[avvefondo]

I am tasked with creating a procedure "Change Management Procedure". What the essential components of this procedure a?

 

[Bev D]

What kind of change?

 

[JimS]

I don't know what your product is, but any changes that impact the quality of the product - which is just about everything - need to be managed and controlled. What do you do to ensure that changes are tested, reviewed, approved, and the solution properly implemented?

 

[Bev D]

and if it is a change that affects the product what is your approach to validation?

But still - what changes is the OP talking about?

 

[FRA 2 FDA]

If you are referring to product changes, I have found that it is extremely helpful, arguably essential, to have a really robust form used for the process. Have the form walk you through as many different areas of impact to consider as possible. People will not always break out the SOP every time. But they will HAVE to use the form. Build in fields to be filled out that address things like regulatory impact, customer notification, stock disposition, etc. That way they are inherently considered and either addressed, or the rationale for nonapplicability included. Put sign offs where they are needed and make different sections of the form that correspond to the flow of the process, i.e. one for the change plan, one for execution of the change, one for effectiveness verification. This approach has helped us tremendously.

 

[bwilliams]

I definitely agree! would you happen to have an example of a detailed change notification form that you could share with the community?

 

[FRA 2 FDA]

Here ya go. This is the rev we currently have under revision so it should be pretty good but may not be perfect quite yet. Hope you find it helpful.

 

[catemu]

Here ya go. This is the rev we currently have under revision so it should be pretty good but may not be perfect quite yet. Hope you find it helpful.

Thanks! I was looking for this.... saves me from starting from scratch.

 

[Wade Wang]

Which articles in Regulation (EU) 2017/745 are applicable to "Change Management Procedure"? What kind of changes do these provisions correspond to? For example: Change of product design, change of production and services, change of document control...etc.