Warning Letter: No records demonstrating the software was validated (ucm459656)

Tags:

Ofni Systems

“Failure to establish and maintain design validation procedures to ensure that devices conform to defined user needs and intended uses and shall include testing of production units under actual or simulated use conditions, as required by 21 CFR 820.30(g).

During an inspection of your firm located in Round Rock, Texason June 16, 2015 through July 2, 2015, an investigator from the United States Food and Drug Administration (FDA) determined that your firm is a manufacturer of the ECG Check Application and ECG Check Wireless Lead Cardiac Monitor (ECG Check Monitor)…

Your firm’s “Design Validations” procedure Revision 1 dated May 22, 2015, states software should be tested according to a test plan and requires the results of this software validation to be maintained in the design history file (DHF). Your firm does not have any records demonstrating the ECG Check Application software was validated.”

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 >>