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This thread is carried over and continued in the Current Elsmar Cove Forums |
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This thread is carried over and continued in the Current Elsmar Cove Forums |
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 The Old Elsmar Cove Forums
 FDA and Medical Devices
 Retention time for Quality records
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| Author | Topic: Retention time for Quality records |
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Monica Lewis Forum Contributor Posts: 19 |
posted 27 July 1998 04:14 AM
   
We are a small company, which coats intraocular lenses. This medical device is sold to a US company. The Company sterilizes the product and sells the product to the customer (eye specialist).For how long time should our company retain the quality record? IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 27 July 1998 11:22 AM
Which quality record? You probably have more than 1. IP: Logged |
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Monica Lewis Forum Contributor Posts: 19 |
posted 27 July 1998 11:30 AM
Dear marc, All the Quality records that are mentioned in ISO 9001 Best regards
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Marc Smith Cheech Wizard Posts: 4119 |
posted 27 July 1998 01:23 PM
ISO9001 does not specify records other than to say you have to identify those records your company believes affect quality. I don't have any FDA regs here nor is it my specialty so I don't know if they give any specific times - But ISO9001 does not specify retention times. In short, your company should have a list of what it considers 'quality records' and each record must have a designated retention time - which your company also determines. Be ready to discuss why your company chose the retention time for each record. Does that help? IP: Logged |
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Don Winton Forum Contributor Posts: 498 |
posted 27 July 1998 08:16 PM
21 CFR 820.180(b) states "All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer." If, as stated, you supply product to another party, I would think that, as a minimum, that two years would be required. Be sure to justify by objective evidence the reasoning for this decision. Hope this helps. IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 27 July 1998 09:11 PM
Thanks, Don. I'm FDA ignorant. I appreciate your taking the 'job' of forum moderator! IP: Logged |
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Monica Lewis Forum Contributor Posts: 19 |
posted 28 July 1998 04:12 AM
Dear Don and Marc, Thanks for answering my question. Marc according to ISO 9001, I can come up with the following records that are required: Management review (4.1.3)
Did I do my math well?
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Marc Smith Cheech Wizard Posts: 4119 |
posted 28 July 1998 09:26 AM
Pretty much so - looks like a fine list to me - But there *may* be other records in your company. When I work with a company in compliance one of the first things I do is ask them to take a DETAILED tour of the company at large and make a list of all the paperwork they find taking a copy of each as it is found. Then comes categorizing and matrixing the documents. The intent is a 'discovery' of all the types of documents in the company. So in short - yoiur list may serve as a minimum (ISO9001 wise) but does not preclude others.
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Don Winton Forum Contributor Posts: 498 |
posted 28 July 1998 05:37 PM
Monica, Marc is very correct. Your list is complete as far as ISO 9000 is concerned. But, the QSR is more stringent than ISO in some areas. It should be prudent to review the QSR, cross tab to ISO and tailor your system to that. The system in place at my firm incorporates the most comprehensive clauses from each (covered on both bases). As an addendum to my previous post. I do not know the details of your firm's business. The records required shall be for the life of the device but in no case less than two years. Under the assumption you supply a customer (as a vendor) and not an end user, two years should be sufficient. I have *.pdf and *.doc of many publications from the CDRH, if you would like copies, please me know. Don IP: Logged |
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Monica Lewis Forum Contributor Posts: 19 |
posted 29 July 1998 03:27 AM
Don, Iwould like to have a copy of publications from the CDRH Monica IP: Logged |
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barb butrym Forum Contributor Posts: 637 |
posted 29 July 1998 08:15 PM
I would like copies as well..if you would Or perhaps you could post them here in *.pdf world.
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Don Winton Forum Contributor Posts: 498 |
posted 29 July 1998 08:47 PM
I have collected three or four dozen documents that refer to the CDRH in particular and the FDA in general. Is there anything in particular you have interest in? If Marc is interested, I could forward to him to post on His board. Don IP: Logged |
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Marc Smith Cheech Wizard Posts: 4119 |
posted 29 July 1998 11:19 PM
Send 'em - I'll post 'em. IP: Logged |
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Don Winton Forum Contributor Posts: 498 |
posted 31 July 1998 01:24 AM
Marc, I will forward as I get them into an organized structure. Please watch. IP: Logged |
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Don Winton Forum Contributor Posts: 498 |
posted 01 August 1998 10:35 PM
Marc, publications are on their way. IP: Logged |
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