Posts: 4119
From:West Chester, OH, USA
Registered:

posted 04 August 1998 03:23 PM               

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This is from Monica Lewis (as some of you know I went through some file corruption problems here and Monica's was one of the records; Her question is as follows:

--> Don or Marc,
--> How do you inerpret this statement: Quality records shall be stored to minimize deterioation and prevent loss.
--> Many companies in Sweden has interpet this wording that quality records shall be keept in locked areas (to prevent loss)
--> and the area shall be fire proof (to prevent deterioation)
--> If You say in the procedure that original quality documents are scanned and a back-up is made. Would this satisfy an FDA
--> inspector?
--> That my last question before a go on a vacation...

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Posts: 4119
From:West Chester, OH, USA
Registered:

posted 04 August 1998 03:26 PM               

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That should be no problem.

Auditor question:

Where do you keep the backup?

Don:---> What say you?

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Posts: 498
From:Tullahoma, TN
Registered:

posted 04 August 1998 10:46 PM               

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The QSR does state in 820.180 that "Such records shall be legible and shall be stored to minimize deterioration and to prevent loss. Those records stored in automated data processing systems shall be backed up." Store records in such a state that to "minimize deterioration and to prevent loss" clause is applied (and if is applicable to your business) and be able to back up with objective evidence. Study "¤ 820.5 Quality systems: Each manufacturer shall establish and maintain a quality system that is appropriate for the specific medical device(s) designed or manufactured, and that meets the requirements of this part." The key word is "appropriate" The example I give is that the "watered down basement" is not acceptable if the records are in a state of "deterioration." Locked, Fire-Proof, etc. are not required as stated in the QSR. Provide data that the records and backups are available including objective evidence (where, when, who, etc.). Show that records that are "years" old are still legible. "DO NOT READ IN WHAT IS NOT THERE." Try the "Don Winton Memorial Post; QSR.PDF" (Thanks, by the way, Marc) for more info. By the way, when an assessor asks, be ready to provide evidence quickly and concisley (sp?). Realize that FDA assessors are not subject to the same RULES as ISO assessors. Do not be afraid or cautious to appeal the FDA's assessors's opinions. You have that right. By the way, Monica. I am gald your deisgn group enjoyed the documents I forwarded. Anything else, feel free to ask.
All for now;
Don

[This message has been edited by Don Winton.]

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