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Agilent ChemStation Plus Method Validation Pack — Data Security

• Report section—all reports are

stored as doc files that have

been printed for the validation

database.

Each section offers a full revision-

ing of the data. Whenever a new

entry in the DMS is made, a new

revision is created. The revision is

uniquely identified through contin-

uous version numbers, the time-

stamp of creation along with the

user name, the database name and

the PC host name. Each revision

of each file can be recreated and

reopened for later review. All DMS

entries are displayed in a hierar-

chical list. Entries can be selected

to view all properties. Additional

information that is stored with

each revision includes:

• name of entry,

• original path,

• label,

• purpose of entry (manual

revision, automatic revision),

• version,

• document type,

• size,

• checksum,

• status (normal, checked-out

and finalized),

• login of user, user domain and

user computer,

• real name of user (display

name),

• reason for check-in,

• check-in date, and

• date of parent entry (i.e. base

node entry).

A click in the checkbox of this

revision offers review of any doc-

ument revision. Clicking a version

child node once displays its prop-

erties. Double-clicking a valida-

53

User authorization

As mentioned under “User man-

agement”, only users with a valid

ChemStation Plus user ID and

their actual password can logon to

the Method Validation Pack soft-

ware. The user management

includes a password policy for

regular password renewal and

user lockout after unsuccessful

password entries. For details,

please refer to ChemStation Plus

Security Pack specifications.

Document management system

Method Validation Pack comes

with a full document management

system DMS storing all data in a

relational Oracle database. For

standalone systems, all data are

stored in a VDB file, a database

file that adheres to a common file

format as used by MS Access.

DMS stores important informa-

tion, which is validation raw data,

such as configuration and plan-

ning, along with the analytical

results and the meta data.

The document management sys-

tem DMS stores all data under the

validation name. It creates a vali-

dation document for each valida-

tion. The validation document has

three subsections as shown in fig-

ure 38.

• VDB section for validation data

base—all data from planning,

configuration, setup and

analytical results.

• MVS section for method

validation sequences—all

ChemStation method validation

sequences that have been

created from a validation data

base.

Figure 38

Method Validation Pack document management system DMS

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