Original Records
Regarding FDA’s Guide for Data Integrity in CGMP, specifically Question 10: I feel that I need to do a bit of a deeper dive here, as there appears to be a disconnect between how industry and the regulator interpret this very important question. Sorry for the length, but I felt I had to cut/paste the entire section of the guidance into this blog for context. I have highlighted in bold the key words leading to confusion and ultimately unnecessary FDA Form 483 Observations. Here we go:
Q: Is it acceptable to retain paper printouts or static records instead of original electronic records from stand-alone computerized laboratory instruments, such as an FT-IR instrument?
PART 1:
A: A paper printout or static record may satisfy retention requirements if it is the original record or a true copy of the original record (see §§ 211.68(b), 211.188, 211.194, and 212.60). During data acquisition, for example, pH meters and balances may create a paper printout or static record as the original record. In this case, the paper printout or static record, or a true copy, must be retained (§ 211.180).
Thoughts:
“If it is the original record” – this is defined by PIC/s (FDA is a member) as the “first capture of information”. Meaning some computerized systems do not capture and store any data – it is simply transient:
older pH meters that simply display the value and create a printout, but do not store any electronic record of the analysis. The printout would be considered the original record. However, there are not many of these left: we might refer to them as CGMP Unicorns?
“or a true copy of the original record” – the process for creating true copies is defined in section 7.7.5 of the PIC/s guidance. The guide states that creating true paper copies of electronic records is “likely to be onerous in its administration to enable a GMP/GDP compliant record”:
This would require someone to periodically perform a 100% reconciliation between the paper printouts and electronic records. This individual would have to sign/date a worksheet or other record certifying that all data has been reconciled between the two sources (paper printouts and electronic). A second person would follow with another 100% reconciliation, and sign/date accordingly as a reviewer. Then the electronic database could be deleted by the IT administrator according to a written procedure, and the paper records could be considered true/exact copies. This is an “onerous” process, and really doesn’t make much business $en$e in any universe.
Additionally, there are many problems with this “true copy” approach, I will just name a few here:
The 100% reconciliation is taxing on front-line employees, and is a procedural control prone to mistakes. Serious deviations are likely, and will be an easy target for regulators.
There may be metadata that is not available on the printouts, but is associated with the original record. This means that true/exact copies are not being created, an easy observation…
You are demonstrating a quality culture that may have been acceptable in the “late 1900’s”, but certainly not today. It will be difficult for your site to survive much longer as quality transparency becomes standardized under FDA’s QMM…
PART 2
However, electronic records from certain types of laboratory instruments—whether stand-alone or networked—are dynamic, and a printout or a static record does not preserve the dynamic record format that is part of the complete original record. For example, the spectral file created by FT-IR (Fourier transform infrared spectroscopy) is dynamic and can be reprocessed. However, a static record or printout is fixed and would not satisfy CGMP requirements to retain original records or true copies (§ 211.180(d)). Also, if the full spectrum is not displayed in the printout, contaminants may be excluded.
Thoughts:
This section makes it seem that dynamic records are the only electronic records that need to be retained according to the record retention expectations. This is unfortunate. I totally get the “dynamic” example and how it helps put the situation in context, but in my opinion this section needs a revision; to clarify it is just an example. Although not in anyway incorrect, it appears to over-simplify what is a complex issue.
The key concept we must grasp to fully understand these first two sections is the concept of the “original record”. If you identify the “first capture of information” (typically electronic) – you then have a clear understanding of what must be done.
Many will argue that the original record on a pH meter or balance “lacks context” because results cannot be linked to specific samples. This statement may have some degree of truth, however, when it comes to the “C” in ALCOA, the history of testing can be very useful when evaluating historical testing for “orphaned data”. Unreported results have no place in a CGMP environment, and it is the role of the data owner to periodically (or frequently, depending on data criticality) monitor for the presence of such instances. This is a patient safety initiative. Context can be re-created if orphaned data is identified, with a nice FDA 483 as a bonus. Others might complain that without context, a CGMP procedure for adequate review cannot be completed. Again, there is of course some degree of truth in that statement, but certainly a simple reconciliation of results could be developed to prevent the presence of unreported results?
PART 3
You must ensure that original laboratory records, including paper and electronic records, are subject to second-person review (§ 211.194(a)(8)) to make certain that all test results and associated information are appropriately reported. Similarly, in microbiology, a contemporaneous written record is maintained of the colony counts of a petri dish, and the record is then subject to second-person review.
Thoughts:
Here we clearly see that the second person review again must be performed on the “original record”, which we now know is the electronic data and associated metadata. If you want to cling on to old habits, like the use of printouts, that’s OK – just don’t be under any illusions that these can be substituted for original records. Original records “are what they are”, either paper (limited instances) or electronic – you can’t choose!
In summary: be cool, follow the rule.
Original records are the new mullets (not the most eye appealing thing out there, but you just can’t not look)!
Pete
