electronic or paper depending on whether electronic or paper is right
In the course of the author’s consultations, he often hears the following assertions
The person in charge at our company fully scrutinizes the records and signs (stamps) them. Therefore, the paper is authentic (original).”
This argument, however, is based on a sexist view.
Regulatory inspections in the U.S. and Europe are generally conducted on the basis of a sexist theory of evil.
If a serious quality problem such as product disposal or recall due to OOS were to occur at the company, the management (responsible person) would be instructed to commit fraud (data falsification) from an economic point of view.
Generally, people in charge do not commit fraud because they have no motivation to do so and no incentive to do so. This is because there is no motivation to cheat and no incentive to cheat.
Therefore, the above assertion that “the responsible party has thoroughly examined the records and signed (sealed) them.” The authorities are not convinced by the assertion that “the person in charge has thoroughly examined the records and has signed (sealed) them.
typewriter inquiry
There used to be this discussion in the US after 21 CFR Part 11 was issued.
The pharmaceutical companies claimed the following
The true record is the paper record. We use computers merely to create records.”
In other words, the argument is that the computer in question is not covered by Part 11 because it is used like a typewriter.
This claim is called “Typewriter Ixcuse,” he calls it.
FDA responded, “Part 11 only applies when the computer is really being used like a typewriter, for example, when electronic records are not being created.” The agency opined.
This is because there are significant differences between typewriters and computers.
Typewriters are characterized by “One Time Printing”. In other words, it can print only once.
In contrast, the computer retains the electronic record and can print it as many times as needed.
This can be used to falsify electronic records, reprint them, and then sign them backdated. This is a fraudulent practice.
Paul Motise, who presided over Part 11 at the time, stated
Printouts cannot be inherently trusted. This is because printouts do not contain the metadata information needed to reconstruct the data or reproduce it from raw data. “
This means that there is no audit trail on paper media, and it is impossible to verify whether a record has been tampered with.
One thing to be aware of is that “hybrid systems (electronic record + handwritten signature) is only a paper version of the signature (name and seal) and < mark style=”background-color:rgba(0, 0, 0, 0)” class=”has-inline-color has-vivid-red-color”>The record is electronic.” This means.
In the case of the hybrid system, regulators examine records electronically and verify signatures on paper during inspections.
Its purpose is falsification detection.
Therefore, electronic records should never be erased just because they have been approved (signed) on paper.
Because the electronic records are positive because they are
Related VOD Distribution Seminars
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・[Super Introduction] Computer Validation & ER/ES
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