Regulatory Open Forum

Hello Keri,

I'm assuming you're talking about equipment calibration files. The standard document retention period is 15-30 years and for medical devices, the documents are to be retained till the expected life of the device but no less than 2 years. 

The documents can be retained as original format OR in electronic format (as in your case). If you choose to use only electronic records, then you will have to make sure to have appropriate procedures for disaster recovery as well as routine system backup, restoring and archiving for all computerized systems.

Thanks,

Mehul

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Mehul Govani
Regulatory Specialist
PL Developments
Westbury NY
United States

Original Message:
Sent: 12-08-2015 09:28
From: Keri Froese
Subject: Electronic Records

We have started migrating to electronic records for the things that we can, which I think is great.  I have a question about calibration records, if I scan these do I need to keep an electronic copy from a regulatory/quality point of view? 

Keri

Assuming these calibration records provide objective evidences that the equipment [what ever was calibrated] the short answer is yes. Retention of these hard copies should be based on your company record information policy 

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Ray Witherspoon
Manager Regulatory Affairs and Quality
ray.witherspoon@mckesson.coMemphis TN 38119

Original Message:
Sent: 12-09-2015 10:26
From: Mehul Govani
Subject: Electronic Records

Hello Keri,

I'm assuming you're talking about equipment calibration files. The standard document retention period is 15-30 years and for medical devices, the documents are to be retained till the expected life of the device but no less than 2 years. 

The documents can be retained as original format OR in electronic format (as in your case). If you choose to use only electronic records, then you will have to make sure to have appropriate procedures for disaster recovery as well as routine system backup, restoring and archiving for all computerized systems.

Thanks,

Mehul

------------------------------
Mehul Govani
Regulatory Specialist
PL Developments
Westbury NY
United States

It is not clear what you mean by calibration records, so I will assume these are calibration certificates and data packages from an external supplier of calibration services. You then ask about the need to keep electronic records. In this I would infer you propose keying in the results from the supplier.

If you scan them in, then you are creating a copy. I would be no different than keeping a copy on paper using a copy machine. Many years ago, you might have captured the image to microfilm. More recently, but still in the “dark ages”, you might have use 8” floppy disks. In all these cases the same principle applies, you have captured an image on some medium.

The next problem is storage. You need to define the record retention time (the storage time) as well as criteria to preserve the record. On paper you need to consider moisture, acid content of the paper, etc. For the floppy disks you need to consider magnetic fields, physical configuration (so they don’t warp over time), etc.

The next problem is retrieval. You should be able to read the record at any time during the record retention time. If you used 8” floppy disks you might have a problem today unless you migrated the image to newer media.

Mehul gave you some record retention requirements, but they were not complete. In FDA QSR the requirement is “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”. In the medical device directive, Annex II the requirement is “for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured”.

I find it useful for a record retention procedure to include both when the retention period starts and the length of the period. Then, the actual records should be marked with, at least, both items to help prevent premature disposal. I have also seen companies specify the disposal method. For example, sensitive information stored in paper records should be shredded, not put in a dumpster.

------------------------------
Dan O'Leary
Ombu Enterprises, LLC
Swanzey NH
United States

Original Message:
Sent: 12-08-2015 09:28
From: Keri Froese
Subject: Electronic Records

We have started migrating to electronic records for the things that we can, which I think is great.  I have a question about calibration records, if I scan these do I need to keep an electronic copy from a regulatory/quality point of view? 

Keri

Original Message------

It is not clear what you mean by calibration records, so I will assume these are calibration certificates and data packages from an external supplier of calibration services. You then ask about the need to keep electronic records. In this I would infer you propose keying in the results from the supplier.

If you scan them in, then you are creating a copy. I would be no different than keeping a copy on paper using a copy machine. Many years ago, you might have captured the image to microfilm. More recently, but still in the “dark ages”, you might have use 8” floppy disks. In all these cases the same principle applies, you have captured an image on some medium.

The next problem is storage. You need to define the record retention time (the storage time) as well as criteria to preserve the record. On paper you need to consider moisture, acid content of the paper, etc. For the floppy disks you need to consider magnetic fields, physical configuration (so they don’t warp over time), etc.

The next problem is retrieval. You should be able to read the record at any time during the record retention time. If you used 8” floppy disks you might have a problem today unless you migrated the image to newer media.

Mehul gave you some record retention requirements, but they were not complete. In FDA QSR the requirement is “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”. In the medical device directive, Annex II the requirement is “for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured”.

I find it useful for a record retention procedure to include both when the retention period starts and the length of the period. Then, the actual records should be marked with, at least, both items to help prevent premature disposal. I have also seen companies specify the disposal method. For example, sensitive information stored in paper records should be shredded, not put in a dumpster.

------------------------------
Dan O'Leary
Ombu Enterprises, LLC
Swanzey NH
United States
------------------------------

Original Message------

Thanks,

My original message was unclear. I meant if I scan the paper records to my server, do I have a need to keep the original paper records sent from the calibration provider or vendor if initial purchase.  

We have retention periods set and excellent backups (I do need to define these in the calibration procedure if this is deemed acceptable).

So my question really is from a Regulatory perspective do I need to keep the original paper or would an auditor accept the scan as the gold standard.

Keri

Dear Keri

In principle, you can scan the original paper documents and keep them as PDFs instead. It is essential though that this process is well described, is validated and quality-assured. By validated I mean: are you sure you scanned all documents? All pages? In colour? Legible? Is the storage location secure (I.e. as secure as a paper location)? Does the quality unit perform spot checks?

Preferably you should scan at 600dpi and convert to PDF/A

ISPE's Electronic Data Archiving guide is a most useful reference / guidance document

Regards

Siegfried

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Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom

Original Message:
Sent: 12-14-2015 08:13
From: Keri Froese
Subject: Electronic Records

Thanks,

My original message was unclear. I meant if I scan the paper records to my server, do I have a need to keep the original paper records sent from the calibration provider or vendor if initial purchase.  

We have retention periods set and excellent backups (I do need to define these in the calibration procedure if this is deemed acceptable).

So my question really is from a Regulatory perspective do I need to keep the original paper or would an auditor accept the scan as the gold standard.

Keri