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Definition raw data

Dear group,

I have a question about the definition about raw data.

We as QAU work in a research and development environment (GMP) and 
would like to make a general definition for raw data for the 
concerning departments. Because some departments have an EDMS in use 
they have already a kind of definition of raw data which fits their 
need. But I am not sure about the correctness of that definition and 
if it will be accepted by governances as FDA.

The definition is that the "first human readable data" is considered 
as raw data. This are are in most cases PDF versions of electronic 
reports. The data that was necessary for making those PDF's is not 
considered as raw data (direct instrument data, metadata). We know 
that it is not possible to reprocess data afterwards because this 
data has no GMP guarantee. But this is no GMP risk but a business 
risk what we accept.

I know the general opinion is to store all the data from te beginning 
till the end, as instrument data, meta data, reprocessing data and so 
on. But in practice it is very hard to store this data on a secure 
and logical way and to hold it accessable for the future. In 10 to 20 
years computer equipment changes a lot and who can guarantee it can 
be used over 20 years with the current equipment.

So I personally see the advantages in the statement of the first 
readable data considered as raw data but I am not sure if this will 
be accepted by FDA or other governances.

Because we are talking about electronic data we will apply the 21 CR 
Part 11 rules for it because this data has a direct GMP value for our 
business.

It would be very helpful for me tho know your opinion in this case.

Best regards and many thanks for your time,

Pedro van den Acker

Ps. I already posted this question in the general GMP group but 
afterwards I found this group which is more suitable. Sorry for the 
crosspost.


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Pedro van den Acker
pedro.vandenacker@organon.com
NV Organon

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