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Procedure Approval - SOPs signed by the President and Regulatory Affairs

S

Sheri Cole

#1
We currently have all of our procedures (SOP's) signed by the President and Reguulatory Affairs approving same. Do you know if this approval is necessary on the paper copy that is kept in Regulatory Affairs? We would like to eliminate this step if possible so that we can process changes in a more timely manner.

Thanks for your help.
 
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S

Sheri Cole

#2
Procedure Approval

I want to update this question...we are a medical device company registered to ISO 13485:2003, ISO 9001:2000, MDD 42/93EEC,CMDR and FDA QSR CFR21.820. We realize that you don't need approval on the ISO standards, but we are concerned about MDD and the FDA.

Thanks for your help.
 

Al Rosen

Staff member
Super Moderator
#3
FDA requires the date and signature (ref: 21cfr820.40 (a), but not necessarily on the document. It reads in part
The approval, including the date and signature of the individual(s) approving the document, shall be documented.
We document the date and signature on a separate card that includes the revision history.
 
S

Sheri Cole

#4
Procedure Approval

Dear Al,
We have a change request procedure which we use for all document changes in the QMS. These are handled the same way as engineering changes and the
document changes are dated, revised and approved by our management team. Do you feel this is sufficient to meet the FDA requirement? I have attached the change request form we use.
5057

Thanks,
Sheri
 

Attachments

Al Rosen

Staff member
Super Moderator
#5
Sheri Cole said:
Dear Al,
We have a change request procedure which we use for all document changes in the QMS. These are handled the same way as engineering changes and the
document changes are dated, revised and approved by our management team. Do you feel this is sufficient to meet the FDA requirement? I have attached the change request form we use.
5057

Thanks,
Sheri
Yes, it meets all the requirements outlined in 21cfr820.40(b).
(b) Document changes. Changes to documents shall be reviewed and approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise. Approved changes shall be communicated to the appropriate personnel in a timely manner. Each manufacturer shall maintain records of changes to documents. Change records shall include a description of the change, identification of the affected documents, the signature of the approving individual(s), the approval date, and when the change becomes effective.
 
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