Record Retention Verbiage Needed for "Lifetime" Retention

Minda

Registered
#1
Good morning, Elsmar friends! I have a question about a document retention period called out in our retention matrix. We have certain records that used to have the record retention period defined as "Forever", but a Notified Body auditor at one point suggested we change it to "Lifetime of the Corporation" as "Forever" cannot be adequately defined. Having "Lifetime of the Corporation" has worked for a couple of years, but now we are getting our EU MDR certification and we have been told that the wording "Lifetime of the Corporation" is not appropriate as it does not ensure retention when the "corporation" changes in the form of business, if the "corporation" is acquired or changes names, or if the "corporation" is closed down at an earlier stage.

Has anyone had any similar feedback from their Notified Body, and how did you handle this? The auditor did not give any suggestions, only the input summarized above, and I would like to get this rectified before it becomes an observation for inadequate document retention period. We toyed around with "Lifetime of the Device Design", but we keep records from older, obsolete designs as well just in case we need to pull anything for any reason. Thanks so much in advance for your expertise!!
 
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Tagin

Trusted Information Resource
#2
For our small company 9001 system, I recently changed our document retention life on 'forever' records (I think I used the word "Indefinite" instead) to a symbolic term, like MAXRETENTION. At the top of the document control section, I state something like:

MAXRETENTION = 15 years

We do not have a regulatory retention requirement for max retention, but instead customer requirements, where we use the longest such customer requirement. So, I also specify along with the above retention definition where that number comes from, so:

MAXRETENTION = 15 years
Note: MAXRETENTION is per customer XYZ requirement.

So, if another customer came along with a longer requirement, we could just update the value and source of MAXRETENTION at the top of the document control doc.
 

Minda

Registered
#3
We have some records that we do name a timeframe for. but others were determined that we should keep them as long as we exist as a company, hence the "Lifetime of the Corporation" verbiage. It is odd that the only fault they are currently finding is the use of the word "corporation", and I'm not sure what else I could use that would be a bit more proper without calling out a number of years. :(
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#4
"Lifetime of the corporation" is also ambiguous; If GE absorbs you the records should not be thrown out. It could be "No less than X years after last product has been produced" but that doesn't cover bankruptcy.

I would give an X years after the last product was produced with a 2-year cushion for its shelf life/intended life.

I like Tagin's response above.
 

Miner

Forum Moderator
Staff member
Admin
#5
We are not medical devices, but we have retention periods like: "Life of product plus 15 years."
 

Ninja

Looking for Reality
Trusted Information Resource
#6
Also not in medical.
I've always used "indefinitely" since they were all in dbases that didn't need culling.
 

Philip B

Quite Involved in Discussions
#7
We go for the lifetime of the device (three years) plus ten years = thirteen years for everything. Has worked fur us so far.
 

Jim Wynne

Staff member
Admin
#9
Good Morning: Does anyone have a suggestion about software validations? We use "continuous".
Is your question pertinent to EU Medical Device Regulations (the topic of this forum)? If so, what specifically are you asking for? You use "continuous" for what? If your question doesn't pertain to the topic, please let us know what standard or standards are of concern so your post may be moved to the correct forum.
 
#10
Yes, this has to do with MDR. We are updating our record retentions and for OTS Software Validations, we use "continuous" for our retention. Do we need to be more specific or is this verbiage ok? Since we are a medical device company, we will use "10 years after discontinued and after last device ships".
 
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