Page 72 - LC-SFC_Pharma_Brochure

The visibility of computer operations refers to retaining the results of
INPUT OUTPUT
operations that require human intervention, such as setting analytical
conditions or analyzing data, and presenting them in a form that is
Instrument Analysis data easily visible. Visibility makes it possible to provide evidence that no
Instrument
parameters (electronic data) improper operations were performed, such as modifying or replacing
parameters
data.
Peak
Peak
integration
integration 8. LabSolutions DB/CS Report Set
8. LabSolutions DB/CS Report Set
parameters
parameters
Implementation of Fig. 3 shows such computer operations presented in a visible form
analysis using the Report Set function in LabSolutions DB/CS version 6.50. The
Batch
Batch Implementation of
settings
settings postruns Report Set function converts a set of reports, such as batch analysis
reports, operation log reports, and chromatogram reports, to PDF
format and then digitally consolidates the reports into a single PDF
file. This report set, which includes the results of operations involving
Security managed by
computer software human intervention, provides visibility of the software operations,
and makes it easy to provide evidence that no improper operations
Manual entry operation were performed, such as modifying or replacing data.
The following are three key features of the report sets.
Fig. 2 Relationship Between Inputs and Outputs for HPLC Analysis
«Feature 1»
Therefore, even if security is strengthened in the computer, it is diffi- Visibility of the Series of Analysis Operations Reduces the Work
cult to prevent improper operations for processes that require human Involved in Checking Results and Ensures Reliability
intervention (such as specifying analytical conditions or analyzing
analysis data). The newly included Report Set function digitally converts
batch analysis reports, operation log reports, chromato-
PDF
gram reports, and other reports into a single PDF file. In this
7. Achieving Visibility for
7 . Achieving V isibility for case, batch analysis reports do not refer to the batch analy- .pdf
Computer Operations
Computer Operations sis schedule but rather to an analysis ledger that summarizes (lists) the
actual series of analyses and the corresponding postrun analyses per-
Consequently, what techniques should be used to provide evidence formed. The operation log report consists of an analysis (and postrun
that no improper operations were performed with regards to analysis analysis) computer operation log that records all analysis operations
results?
(and a postrun analysis) performed between the start and finish of
This can be accomplished by ensuring that computer operations are the analysis processes.
easily visible.
Inside the LabSolutions Database
Implementation of Generation and storage of
Preparation of analysis analytical data
samples

Login Logout
Link
(Between data to the report set) Breakdown of other reports
Analysis conditions settings • Instrument parameter reports
• Data processing parameter reports
Report Set
PDF • Calibration curve reports Checker
Instrument
Instrument
parameters
parameters
Breakdown of the report set
Login
Check Electronic signature
Peak
Peak Logout
Batch reports
Batch r
eports
eports
eports
Other r
Other r
integration
integration Batch r eports Other reports
parameters
parameters
Approver
Chromatogram
Chr
Operational Chr omatogram
Operational
Operational
omatogram
log reports
log r
eports
eports
eports
Batch log r eports r r reports Login
Batch
settings
settings Approval Electronic signature
Logout
Fig. 3 Data Integrity Compliance Using LabSolutions DB/CS Report Set
3