Warning Letter: Failure to validate off-the-shelf software (ucm185181)

Tags:

Ofni Systems

Failure to validate computer software for its intended use according to an established protocol, as required by 21 CFR 820.70(i). For example, your firm uses off-the-shelf software that generates the labels for the dental alloys. The off-the-shelf software has not been validated for this use.

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 >>