Kaye Validator 2000 vs new narrow scope of FDA Part 11

Hi everyone.

We are currently evaluating all systems used under GxP, company wide, to determine what system is qualifying for a Part 11 gap analysis.
Since most of the systems are used to generate paper documents, which are the only source of reference when performing regulated activities, it was found that Part 11 did not apply to almost every systems. Good for us… :wink:

There is an equipment that is giving us some problems and we would like to hear your thoughts about it. The equipment is the Kaye Validator 2000.

Although it is fully compliant to “Standard Part 11”, we believe that under FDA narrow scope of Part 11 (
http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
), Part 11 would not apply to thermal data generated…

Here are our evaluation of the situation:

    All data produced by the system are printed on paper and each of these documents are reviewed and approved (hand signature and date)
    After all documents are printed, it is no longer needed to come back to the system to "look or reprocess" data (nobody will use stored data to perform reg activities)
    Records are not submitted to the FDA

Is it enough for Part 11 to not apply to this equipment?
Even though this equipment is using electronic signature everywhere when performing thermal qualifications?

Thanks.

[quote=f.leduc]Hi everyone.

We are currently evaluating all systems used under GxP, company wide, to determine what system is qualifying for a Part 11 gap analysis.
Since most of the systems are used to generate paper documents, which are the only source of reference when performing regulated activities, it was found that Part 11 did not apply to almost every systems. Good for us… :wink:

There is an equipment that is giving us some problems and we would like to hear your thoughts about it. The equipment is the Kaye Validator 2000.

Although it is fully compliant to “Standard Part 11”, we believe that under FDA narrow scope of Part 11 (
http://www.fda.gov/regulatoryinformation/guidances/ucm125067.htm
), Part 11 would not apply to thermal data generated…

Here are our evaluation of the situation:

    All data produced by the system are printed on paper and each of these documents are reviewed and approved (hand signature and date)
    After all documents are printed, it is no longer needed to come back to the system to "look or reprocess" data (nobody will use stored data to perform reg activities)
    Records are not submitted to the FDA

Is it enough for Part 11 to not apply to this equipment?
Even though this equipment is using electronic signature everywhere when performing thermal qualifications?

Thanks.[/quote]

Based on the information you provided I believe that this applies:

Under this narrow interpretation, FDA considers part 11 to be applicable to the following records or signatures in electronic format (part 11 records or signatures):

(Bullet #2) Records that are required to be maintained under predicate rules, that are maintained in electronic format in addition to paper format, and that are relied on to perform regulated activities.

In some cases, actual business practices may dictate whether you are using electronic records instead of paper records under § 11.2(a). For example, if a record is required to be maintained under a predicate rule and you use a computer to generate a paper printout of the electronic records, but you nonetheless rely on the electronic record to perform regulated activities, the Agency may consider you to be using the electronic record instead of the paper record. That is, the Agency may take your business practices into account in determining whether part 11 applies.

(Bullet #4) Electronic signatures that are intended to be the equivalent of handwritten signatures, initials, and other general signings required by predicate rules. Part 11 signatures include electronic signatures that are used, for example, to document the fact that certain events or actions occurred in accordance with the predicate rule.

I was ok up to here. And then you said:

This seems incongruous with the first part. If you’re applying signatures electronically, I think you’re in scope.

The bit about records not being submitted to the FDA is irrelevant. If, in the execution of your Quality System, you manage electronic records or apply signatures electronically, you’re potentially in scope.

Of course, you’ve validated the Kaye Validator 2000 for it’s intended use (irrespective of the Part 11 question), right?

Sorry, I was out of order for a few days…

Yeah you both were right.

Because of the electronic signature, even if everything would be printed out, it would still be electronic signature applied, on regulated activities, meaning that Part 11 would apply…

And yes, it had been validated but at that time, part 11 functionality were not activated. Who knows why…

Thanks guys