Warning Letter: Failure to validate Excel Spreadsheet (ucm256498)

Tags:

Ofni Systems

Failure to validate software used as part of production or the quality system for its intended use according to an established protocol, as required by 21 CFR 820.70(I). For example, your firm did not validate use of an Excel spreadsheet used to calculate the Moisture Vapor Transmission Rate (MVTR) per test procedure [redacted] Revision B.

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 >>