QS0004-01: Documentation Procedures Flashcards

1
Q

QS0004-01: Documentation Procedures

What is required of a reviewer?

A

That the individual be qualified, and not be the same person having done the work.

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2
Q

QS0004-01: Documentation Procedures

What is required of documentation for an activity or event?

A

That it be a clear, accurate history

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3
Q

QS0004-01: Documentation Procedures

What standards must be applied to electronic signatures?

A

Printed name and date and time signature was executed.
The meaning associated with the signature (e.g., review, approval, authorship)

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4
Q

QS0004-01: Documentation Procedures

What form of documentation, paper or electronic, is generally acceptable for use?

A

Electronic

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5
Q

QS0004-01: Documentation Procedures

Must documentation be traceable to the individual or origin?

A

Yes. This usually occurs by way of unique logins, however, if entries are made on behalf of someone else, or observations were made by other individuals, these should be noted.

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