Warning Letter: Incomplete documentation of validation (s6741c)

Tags:

Ofni Systems

Failure to adequately establish and maintain procedures for validating the device design, as required by 21 CFR820.30(g). For example:

a. Device software validation is incomplete. For example, the documentation of the external validation testing for the [redacted] Scanner conducted by a Canadian site in 2005 reveals incomplete sections rating the effectiveness of the scanner.

b. Discrepancies that were noted at the completion of design validation are not addressed. For example, the final validation report for the [redacted] noted an issue regarding “streak” artifacts at one of the clinical sites; however, there was no further documented evaluation of this artifact to include significance and potential risk prior to the finalization of the design validation and commercial distribution.

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 >>