Warning Letter: Failure to Establish Validation Program (ucm366715)

Tags:

Ofni Systems
 
"your firm failed to establish a
validation program
for the computer software Microsoft Dynamics used for production, inventory, lot number generation, and laboratory test methods used for raw material, bulk, and finished product test release.  Your firm also uses the Microsoft Dynamics program to assist your quality unit for product, document and component control.

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 >>