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Does Part 11 apply to electronic systems that can print records but do not have a durable storage media (i.e. flash memory or memory buffer, etc.)?

April 26, 2017durable electronic flash memory media print records storage SYSTEMS

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Does Part 11 apply to electronic systems that can print records but do not have a durable storage media (i.e. flash memory or memory buffer, etc.)?

2 Answers

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The question is really not that much for the storage media, it’s more whether the operator can manipulate the data before they are printed. The real problem is that most of this equipment does not have functions as required by part 11.

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The question is really not that much for the storage media, it’s more whether the operator can manipulate the data before they are printed. The real problem is that most of this equipment does not have functions required by part 11.