Notification Sample Regarding Record Retention

NikkiQSM

Quite Involved in Discussions
#1
Hello Cove Dwellers -

I have a rather simple task to conduct but it is giving me some difficulties...

We recently changed our record retention from 3 years to 15 years.

Our GM has requested that a letter is to be typed up (by yours truely) to explain this change and state our record retention time.

The letter will be sent to all of our medical customers.

Customer Service has asked that I write out this letter, sign it as well, and then they would forward it onto the appropriate customers.

I personally think a "letter" is a little excessive. A general statement via email to the customers would work just fine IMO...

I am looking for examples of a notification of record retention that I could review and maybe work off of to produce this letter.

Besides the simple statement: "Our Company retains all records for 15 years." - what else should I include in this letter?

Thanks in advance for your advice, suggestions, and thoughts. :agree1:
 
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NikkiQSM

Quite Involved in Discussions
#3
What is the reason for the retention time change?
It's been stated as 3 years from the since the beginning of the Company..

More and more customers are asking that we keep records for 10 years, some say the life-time of the medical device they make from the product...

We recently had a Management Council Meeting and decided 15 years was appropriate.
 
L

lfrost

#4
It's been stated as 3 years from the since the beginning of the Company..

More and more customers are asking that we keep records for 10 years, some say the life-time of the medical device they make from the product...

We recently had a Management Council Meeting and decided 15 years was appropriate.
Nikki,

In 21CFR820.180 General Requirements it states that:

Sec. 820.180 General requirements.


All records required by this part shall be maintained at the manufacturing establishment or other location that is reasonably accessible to responsible officials of the manufacturer and to employees of FDA designated to perform inspections. Such records, including those not stored at the inspected establishment, shall be made readily available for review and copying by FDA employee(s). 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.
(a)Confidentiality. Records deemed confidential by the manufacturer may be marked to aid FDA in determining whether information may be disclosed under the public information regulation in part 20 of this chapter.
(b)Record retention period. 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.
(c)Exceptions. This section does not apply to the reports required by 820.20(c) Management review, 820.22 Quality audits, and supplier audit reports used to meet the requirements of 820.50(a) Evaluation of suppliers, contractors, and consultants, but does apply to procedures established under these provisions. Upon request of a designated employee of FDA, an employee in management with executive responsibility shall certify in writing that the management reviews and quality audits required under this part, and supplier audits where applicable, have been performed and documented, the dates on which they were performed, and that any required corrective action has been undertaken.
From what this states, I would think that you will need to retain your records for two years after the last device has been manufactured. This is the length of time that we retain our records for our medical devices. We just stopped manufacuring one device that we have been making for 12 years. That means that our records will need to stay active and retained for two more years.

I hope this helps my :2cents:.

Added in edit: I think that this is one of the reasons why some of your customers are requesting changes in your record retention practices. They might have to follow the FDA QS regulation that mandates a longer retention time than three years.
 
Last edited by a moderator:
I

isoalchemist

#5
Also 21CFR180(b) points up a good reason against a blanket 15 year retention that could be overkill or not long enough. The Q&R world is never filled with simple answers and the answer will probably will change based on the next guidance document or standard revision issue.
 
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