QS0004-01: Documentation Procedures Flashcards
QS0004-01: Documentation Procedures
What is required of a reviewer?
That the individual be qualified, and not be the same person having done the work.
QS0004-01: Documentation Procedures
What is required of documentation for an activity or event?
That it be a clear, accurate history
QS0004-01: Documentation Procedures
What standards must be applied to electronic signatures?
Printed name and date and time signature was executed.
The meaning associated with the signature (e.g., review, approval, authorship)
QS0004-01: Documentation Procedures
What form of documentation, paper or electronic, is generally acceptable for use?
Electronic
QS0004-01: Documentation Procedures
Must documentation be traceable to the individual or origin?
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.