Enhanced Security Mode - PerkinElmer Wallac 1420 User Manual

Introduction

Enhanced Security mode

Wallac 1420 has an Enhanced Security mode intended for facilities that have to comply
with 21 CFR Part 11 regulation from the Food and Drug Administration (FDA) of the USA.
During installation you can select if you want to use the Enhanced Security mode. Once you
have enabled this mode you cannot disable it because to do so would not be in compliance
with 21 CFR Part 11.
The regulation (21 CFR Part 11) sets the criteria under which the agency (FDA) considers
Electronic Records and Electronic Signatures (if applied) to be trustworthy, reliable and
generally equivalent to traditional paper records and hand-written signatures executed on
paper. The regulation applies to records in electronic form that are created, modified,
maintained, archived, retrieved, or transmitted, under any records requirements set forth in
agency regulations (i.e. GMP, GLP, GCP...). It also applies to electronic records submitted
to FDA under requirements of the Federal Food, Drug, and Cosmetic Act.
The Enhanced Security mode for Wallac 1420 provides the technological controls and
features to support full 21 CFR Part 11 compliancy. These features can be classified under
three main headings:
•
improved access control (unique Userid/Password combination) with five user
levels
•
improved data security
•
audit trails of user actions
This manual and the electronic help will tell you how to use Wallac 1420 with or without
the Enhanced Security mode. All differences in use are noted and explained.
Note: use of the Enhanced Security mode does not alone ensure compliance with 21
CFR Part 11. Any facility that wants to be compliant with the 21CFR Part 11
regulation must also implement the necessary procedures and controls set by the
regulation.
Please refer to Appendix 4 for details of special functions that are part of the Enhanced
Security mode.
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