HP LC2000r - NetServer - 128 MB RAM Specifications download pdf (Page 35)

Data management and audit-

trails

All configuration and result data

along with the MVS files and vali-

dation reports form the "validation

database". Each validation has its

own database. It is stored in a

relational database for full data

integrity and to ensure data secu-

rity. Every validation modification

or configuration change is stored

in the database as a new version

of the existing validation. All

changes and modifications are

documented either in the program

audit-trail (for program related

events such as logon) or in the

validation audit-trail.

35

Result data entry and statisti-

cal calculations

After completion of the analytical

experiments the results can be

uploaded from the ChemStore

database into Method Validation

Pack. The upload from ChemStore

is an active and automated direct

database data access. The transfer

is executed as defined in the plan-

ning of the validation experiments.

The analytical results are con-

tained in the ChemStore database

whereas the validation results are

contained in Method Validation

Pack. Traceability of results is

achieved with unique run-IDs in

ChemStore for each result version.

The ChemStore run-IDs are also

transferred and displayed along

with the analytical results in the

Method Validation Pack.

When all result data is imported,

the validation report can be print-

ed. This report displays all data

related to the validation as defined

in the top-level validation configu-

ration. This includes the compo-

nents, their planning and result

data as well as the calculation

results and conclusions, for exam-

ple, "outliers [not] detected" along

with result representation in

charts.

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