Specifications

offering advanced data security,
data integrity and full change
documentation in audit-trails.
Specifications of the ChemStore
C/S database module are available
in the ChemStore C/S section of
this document.
To achieve data security, the
ChemStation Security Pack utilizes
a combination of Windows user
accounts and file permissions and
auditing. In addition, it utilizes an
application-related second layer of
data security based on standard
database security features. The
application-related security
requires a valid ChemStation Plus
user account allowing the log-on to
the application. A user with admin-
istrative priviledges can assign
appropriate user permissions to
other users within the Chemstation
Plus software.
The ChemStation Plus Security
Pack software allows to match user
tasks in the laboratory with user
roles in the software. It modifies
the ChemStation operator rights,
allowing to routinely operate the
ChemStation application in the
operator mode. For proper use and
to achieve the best data security
capabilities of Security Pack, all
users except those with administra-
tive functions should utilize the
ChemStation operator mode.
To achieve data integrity, all users
are required to log on to a single
database. This database (determi-
nation of the database connection
requires the log-on to the Windows
operating system with an adminis-
trator account) will store all raw
and meta data. In addition, any
recalculation of results in the
ChemStation will automatically be
recognized as a new result ver-
sion and will be transferred to the
database as a new version. This
versioning assures that no data is
ever lost or overwritten and that a
complete chain of events is docu-
mented.
To achieve data traceability, the
ChemStation Plus Security Pack
utilizes logbooks and audit trails
that document who did what,
when and why. These logbooks
and audit trails are user-indepen-
dent and cannot be modified or
deleted.
All data is in electronic format
and capable of long-term storage/
recall and printing in human read-
able format.
Key product features of the
ChemStation Plus Security Pack
include storage of all chromato-
graphic data in a relational data-
base, such as
• password protection to access
the data,
• full data protection using
Windows security and data-
base security tools,
• application protection with a
mandatory log-in,
• user management with indivi-
dual user profiles and privi-
leges for the application–
independent of the operating
system,
• an application-specific session
lock allowing to lock one
ChemStation session while
leaving a second instance
running on the same PC, and
• an automated time-based appli-
20
Product Description
The ChemStation Plus Security
Pack is a module of the Agilent
ChemStation Plus Series designed
to support the requirements of 21
CFR Part 11. In the Agilent
ChemStation the ChemStation
Plus Security Pack modifies data
analysis and provides advanced
data management with regard to
supporting the requirements for
electronic records. It also offers a
procedure to sign off runs with an
electronic signature. It offers an
easy upgrade for an existing
ChemStation installation.
The Agilent ChemStation Plus
Security Pack is compatible with
the following ChemStation
modules:
• Agilent ChemStation for GC,
LC, A/D, CE, CE/MS and LC/MS
for instrument control and data
analysis
• Agilent ChemAccess C/S
remote instrument control
• Agilent ChemStore C/S data
organization and data storage
module
• Agilent ChemStation Plus
Method Validation Pack
The UV-Vis ChemStation offers a
separate solution for 21 CFR Part
11. Please refer to the specifica-
tions of the UV ChemStation
Security Pack included in publica-
tion number 5980-0678E.
The ChemStation Plus Security
Pack is available as a standalone
solution or in a fully integrated
client server network connected
to the ChemStore C/S server
Oracle database. It provides full
support of 21 CFR Part 11 by
Agilent ChemStation Plus Security Pack
3.