Warning Letter: Use of electronic signatures to approve procedures (ucm446035)

Tags:

Ofni Systems

“Failure to establish and maintain procedures to control all documents, as required by 21 CFR
820.40. For example, your firm failed to follow its Documentation Management procedure since it
used electronic signatures to approve numerous procedures. Your firm’s procedure states that
there are no currently-approved electronic signature systems implemented at your firm.”

View the original warning letter.


Recommended Solutions

Compliance Training >>

Recommended Solutions

ExcelSafe >>

Recommended Solutions

Ofni Clinical >>

Recommended Solutions

Part 11 Toolkit >>

Recommended Solutions

Part 11 Advisor >>

Recommended Solutions

MedWatch Reporter >>

Recommended Solutions

Computer Validation >>

Recommended Solutions

Custom Programming >>

Recommended Solutions

Validating MS Excel Spreadsheets >>

Recommended Solutions

Access Databases >>