Does FDA allows remote approvals of quality documentation. Is there any specific guidance on signing any quality records remotely?

[gerchik]

I am searching for any specific info regarding the approval or signing of quality records remotely. Is there any specific FDA guidance on signing any quality records remotely?

 

[Ed Panek]

Part 11, Electronic Records; Electronic Signatures - Scope and Application | FDA

I created a checklist we use for electronic records.

Guidance Ref. No. Requirement
11.10 Controls for closed systems
11.10a Validation of Systems
11.10b FDA Copies
11.10c. Protection and recoverability
11.10.d Limiting system to authorized individuals
11.10e Audit Trails
11.10f Operation Sequences
11.10g Authority checks
11.10h Device Checks
11.10i Training
11.10j Establishment and adherence to written policies
11.10k Control over Documentation
11.30 Controls for Open Systems
11.50 a/b Signature Manifestations
11.70 Signature/record linking
11.1001 a,b, c Electronic Signatures
11.200 a, b Electronic signature components
11.300a Uniqueness of each combined identification code and password
11.300b Changing and aging of credentials
11.300c Loss Management Procedures
11.300d Safeguards to prevent unauthorized access
11.300e Initial and periodic testing of authentication devices


Some may or may not apply to you but you should add a column for objective evidence or document reference.