Paper printouts

Hi,

Nice forum,

When you use a computer-based system that generates electronic
records and paper printouts of these electronic records, but you
nonetheless want to rely only upon the paper records to perform
regulated activities, are you in an hybrid system or in a paper
system?
Is it possible to maintain the electronic records if they can’t be
modified before printout without trigging Part 11?
Thank you in anticipation for your help.

My take is you are in a hybrid system, since your record trail
relies on the electronic system’s original records for non-
reputiation.

I am looking to have the this verified by other people in this
usergroup. Did anyone else ever reply?

Peter

Hi,
Will answer your question in two parts
Q1.When you use a computer-based system whitch generates electronic
records and paper printouts of these electronic records, but you
nonetheless want to rely only upon the paper records to perform
regulated activities.

A1. In this type of scenario, it needs to be looked upon whether the
user can change the values before the final print is taken. If the
user is able to make the changes, in that case the records will fall
under electronic records and 21 CFR part 11. The auditor can ask for
the raw data during audit even if one claims that the reliance is
only upon the paper records to perform regulated activities.

Q2.Is it possible to maintain the electronic records if they can’t
be modified before printout without trigging Part 11?

A2. I understand that your question is, whether it is required to
maintain electronic records if they can’t be modified before
printout. The answer is big “NO”. Take a classic example of IR
spectrometer, in which an analyst puts the sample sets the method
and the analysis is perfomed.The results of the analyis is printed
out directly without any oppotunity for the anlyst to make any
changes. Here if you take a call that only hard copy printout of the
results are used for regulatory purposes in that case the IR
spectrometer does not falls in the scope of Part 11, as there is no
electronic record as a result no need to mainatin the same.
I strongly suggest that you document the decisions with suppoting
documents.And follow the same properly.
Regds

I tend to agree with Graham. Q1: First and foremost, you have to document what is your official record. Second, if you don’t have the proper controls in place, you can’t use the electronic records.

Q2: Since you already have an electronic record, you would have to adhere to the regulation. The regulation states "This part applies to records in electronic form that are created, modified, maintained, archived, retrieved, or transmitted, under any records requirements set forth in agency regulations.

It doesn’t really matter if you can’t edit it. if you are storing an electronic record to be accessed later.

Boy, you guys are just all over the place on this question. Unfortunately
no one has asked the fundamental question. At what point in the "Records"
life cycle does it satisfy the predicate rule? IMO, there are only two
points where this happens, when the record is created, or when the record is
approved (institutionalized).

For “Records” such as laboratory data (i.e. HPLC chromatographs, IR, UV, and
Vis Spectra) this point is normally when the “Record” is created. It should
be noted that there are a few sub-issues the need to be addressed.

  • First, is the user able to modify the data? That is the say, can
    the actual absorbance values be changed. Or can the use only change related
    metadata such as the batch number of the sample he is running. If the data
    is directly modifiable by the user, then you have a high risk Part 11 issue
    and strong measures need to be taken to ensure the integrity of the data.
    If only the metadata can be changed, then the risk is less significant, and
    it may be possible to create a manual control mechanism for the process.
  • Second, does the system generate a complete “Record”? There is a
    lot of debate regarding this subject. IMO, HPLC chromatographs that are
    printed to paper are incomplete, in that the paper records cannot be
    re-integrated or further analyzed in the same manner as electronic records.
    This position was substantiated to my satisfaction via a presentation given
    by George Smith, Consumer Safety Officer - CDER at the GAMP Forum meeting in
    Morristown in the spring of 2006. On the other hand, “Records”, such as
    spectra, are usually complete, as no further analysis would be revealing
    (usually). It should be noted that for Spectra, if you are using a computer
    to match the spectra to a standard, the official record is electronic.

For “Records” such as SOPs and regulatory submissions, the point at which
the “Record” meets the predicate rule requirement is normally when the
document is approved (institutionalized).

  • “Records” that are electronically created, then printed out and
    approved, generate official records that are exclusively paper and there is
    no electronic record component.
  • “Records” that are approved electronically, then printed and
    physically distributed are hybrid and both the electronic and paper
    components are official records and must be maintained in unison. In
    addition, “Records” that are printed, signed and then scanned and
    distributed are equally hybrid.
  • “Records” that are electronically created, approved and distributed
    are exclusively electronic records.

Hey, Really late reply to post but gold never becomes old…

Such a detailed defination of Records with proven real time example are really good. Thanks Maryacton.