Warning Letter: Validation under operating conditions(ucm239018)

Tags:

Ofni Systems

Failure to validate the design under defined operating conditions and by using initial production units, lots, batches, or their equivalents, as required by 21 CFR 820.30(g). Your firm failed to perform design validation for the data analysis software used in the Cal Ver EP Evaluator to determine out of specification stability results for Verichem products.

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 >>