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Related Topic Tags
physical sample, quality records, samples and sampling plans
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  #1  
Old 14th May 2008, 10:43 AM
Triboyle Triboyle is offline
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Please Help! Sample Retention Requirements - Quality Records procedure - ISO13485

Hello all,
just a quick query.l am writing up a control of Quality Records procedure and under the heading of sample retention, i have hit a block.
We are a start up medical device company and as of yet, have no samples to retain. Is there a requirement to retain a certain amount of samples, when the device is a disposable, transient use, class 1 device (or class 2a MDD)? I know there are regulations around length of time for document retention, but are there any for sample retention? Should it even be in a control of records procedure?

Many thanks in advance,
Tri

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  #2  
Old 14th May 2008, 02:28 PM
QA-Man QA-Man is offline
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

ISO 13485 says "The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements"

It would be a good starting point to define the expected lifetime of the device.

I would take the greatest lifetime of all your devices and add a year or two to make things easy.

We're also a startup and use the following retention times. Note: The numbers are actually based on Japanese MHLW requirements

Physical copies of records are maintained for a minimum of 3 years. If there is no electronic equivalent the following applies:
  • Records related to personnel, training, and human resources will be maintained for 6 years
  • Records related to devices will be maintained for 16 years or the life of the device, whichever is greater.
Electronic records are maintained indefinitely
Thank You to QA-Man for your informative Post and/or Attachment!
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Old 15th May 2008, 06:39 AM
Triboyle Triboyle is offline
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

Quote:
In Reply to Parent Post by QA-Man View Post

ISO 13485 says "The organization shall retain the records for a period of time at least equivalent to the lifetime of the medical device as defined by the organization, but not less than two years from the date of product release by the organization or as specified by relevant regulatory requirements"

It would be a good starting point to define the expected lifetime of the device.

I would take the greatest lifetime of all your devices and add a year or two to make things easy.

We're also a startup and use the following retention times. Note: The numbers are actually based on Japanese MHLW requirements

Physical copies of records are maintained for a minimum of 3 years. If there is no electronic equivalent the following applies:
  • Records related to personnel, training, and human resources will be maintained for 6 years
  • Records related to devices will be maintained for 16 years or the life of the device, whichever is greater.
Electronic records are maintained indefinitely
Many thanks for that. Does your quality record procedure include sample retention? If so, do you retain samples for the same length of time as your paper records?
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Old 15th May 2008, 09:23 AM
QA-Man QA-Man is offline
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

I am not sure what you mean by sample. Do you mean an actual device?
Thanks to QA-Man for your informative Post and/or Attachment!
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Old 15th May 2008, 11:55 AM
Triboyle Triboyle is offline
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

Yes, i have seen in other Control of Quality Records procedures for medical device companies that samples of each batch are held in case of testing needs later?
It seems an unusual place to store such instruction though and i cannot seem to find any regulation that requires it?
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Old 15th May 2008, 12:20 PM
QA-Man QA-Man is offline
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

There are no regulatory requirements governing this (that I'm aware of).

Its not a bad idea to keep product samples but it might be impracticle. How many samples would you retain for each batch. How big are your products? Do you have the room to store them all for the life of the device?

You should absolutely define the controls and retention periods for all records related to the product. This includes design history records (shop/production travelers), manufacturing methods (work instructions), testing methods (incoming, in-process & final), operating procedures, labeling, instructions for use, traceability records, etc.

This way you can build a snapshot of the product at any point in time for any given batch.
Thank You to QA-Man for your informative Post and/or Attachment!
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Old 16th May 2008, 09:13 AM
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

That's great. Many thanks for your help.
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Old 19th May 2008, 11:36 AM
Roland Cooke Roland Cooke is offline
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Re: Sample Retention Requirements - Quality Records procedure - ISO13485

Records can of course include physical samples (often kept for re-testing in the event of a future complaint investigation being required).

Lifetime may actually mean a person's lifetime, in the case of certain implants.

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