Hello-
Does anyone have a somewhat "simplified" sort of a checklist outlining what is required for ensuring that computer systems generating results are fully validated and part 11 compliant based on FDA requirements? We are working on moving to a new "Labware" system to run all of our HPLCs, GCs, etc. and our IT department needs guidance on what is needed to ensure FDA compliance and I am struggling with providing a clear, understandable outline of what is required.
Thank You!
Angela L. Siracusa ASQ CQA
Quality Assurance Manager
Consumer and Retail Services
--------------------------------------------
UL Verification Services, Inc.
85 John Road
Canton, MA 02021 USA
T +1.781.644.1747
F +1.781.821.9266
E Angela.L.Siracusa@ul.com
Please note: New direct dial phone number
This e-mail may contain privileged or confidential information. If you are not the intended recipient: (1) you may not disclose, use, distribute, copy or rely upon this message or attachment(s); and (2) please notify the sender by reply e-mail, and then delete this message and its attachment(s). Underwriters Laboratories Inc. and its affiliates disclaim all liability for any errors, omissions, corruption or virus in this message or any attachments.