Warning Letter: Failure to validate computer software (ucm265239)

Tags:

Ofni Systems

Failure to validate computer software for its intended use according to an established protocol , as required by 820.820.70(i). Your firm uses the [redacted] for in-process and final product testing for the [redacted] and the [redacted]. Your firm conducted software validation for the [redacted] and the results are included in the Software Validation Report, dated February 11, 2010.

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 >>