The OMNIC™ Series Software allows you to quickly and easily acquire, process, analyze, and manage FT-IR or Raman data in a graphical environment that is.

Read OMNIC Software: 21CFR Part 11 Compliance text version The information in this publication is provided for reference only. All information contained in this publication is believed to be correct and complete. Thermo Nicolet Corporation shall not be liable for errors contained herein nor for incidental or consequential damages in connection with the furnishing, performance or use of this material. The hunger games ost rare. All product specifications, as well as the information contained in this publication, are subject to change without notice. This publication may contain or reference information and products protected by copyrights or patents and does not convey any license under the patent rights of Thermo Nicolet Corporation, nor the rights of others.

Thermo Nicolet Corporation does not assume any liability arising out of any infringements of patents or other rights of third parties. Thermo Nicolet Corporation makes no warranty of any kind with regard to this material, including but not limited to the implied warranties of merchantability and fitness for a particular purpose. Copyright © 2002 by Thermo Nicolet Corporation, Madison WI 53711. Printed in the United States of America. All world rights reserved.

No part of this publication may be stored in a retrieval system, transmitted, or reproduced in any way, including but not limited to photocopy, photograph, magnetic or other record, without the prior written permission of Thermo Nicolet Corporation. For technical assistance, please contact: Thermo Nicolet Corporation 5225 Verona Road Madison WI Telephone: 800-642-6538 or 608-276-6373 Fax: 608-273-6883 E-mail: OMNIC is a registered trademark and Val-Q, Val-Q DS, Smart Accessory, RESULT, Antaris and ValPro are trademarks of Thermo Nicolet Corporation. Windows and Windows NT are registered trademarks of Microsoft Corporation. 269-114902 Contents OMNIC Software: 21 CFR Part 11 Compliance.... 1 History........

1 Definitions....... 2 Key subparts of Part 11: Electronic records; Electronic signatures.. 3 OMNIC software....... 3 21 CFR Part 11 Compliance Statement.... 4 Part 11: Electronic records; Electronic signatures... 5 Subpart B: Electronic records..... 5 §11.30 Controls for open systems....

11 §11.50 Signature manifestations.... 11 §11.70 Signature/record linking.... 11 Subpart C: Electronic signatures..... 12 §11.100 General requirements for electronic signatures.. 12 §11.200 Electronic signature components and controls.. 12 §11.300 Controls for identification codes/passwords.. 13 Summary.......