QS0004-01: Documentation Procedures

Question 1

QS0004-01: Documentation Procedures

What is required of a reviewer?

Answer 1

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

Question 2

QS0004-01: Documentation Procedures

What is required of documentation for an activity or event?

Answer 2

That it be a clear, accurate history

Question 3

QS0004-01: Documentation Procedures

What standards must be applied to electronic signatures?

Answer 3

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

Question 4

QS0004-01: Documentation Procedures

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

Answer 4

Electronic

Question 5

QS0004-01: Documentation Procedures

Must documentation be traceable to the individual or origin?

Answer 5

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.