Certified copies

[Lisa Mulcahy]

This question is about the literal interpretation of the requirement for creation of certified copies as well as soliciting inspection experiences associated with the certification process. I would appreciate any information on any of the following questions:

1) Does your company certify electronic files that are uploaded to the eTMF system? Does your company consider these uploaded files as copies?

2) Does your company make certified copies only when a file format is changed, such as paper format to electronic record(pdf)?

3) Is your company’s certified copy process limited to only wet-ink paper TMF documents?

3) How much are inspectors reviewing and issuing findings on the certified copy process? Are they checking it at all during inspections?

Thank you for any response you might provide. -Lisa

• This topic was modified 2 years, 11 months ago by Lisa Mulcahy.

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