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Data Integrity C
ompliance in the A
nalytical Laboratory
C191-E047
Solutions Offered by Shimadzu Corporation
Data Integrity Compliance in the Analytical Laboratory
© Shimadzu Corporation, 2019First Edition: February 2019, Printed in Japan 3655-02902-20AIT
Reducing Potential Risks in Analysis/Postrun Work�ow - LabSolutions DB/CS Report Set
It is impossible to determine from looking at a chromatogram or other analytical data obtained whether or not the data was acquired using
correct test parameter settings (such as instrument or data processing parameter settings). Furthermore, the possibility of test parameters being
tampered with cannot be ruled out. However, LabSolutions DB/CS Report Set can be used to link analytical data with metadata (results from
parameter settings, data analysis, and other processes that involve human intervention) and with the entire series of actions recorded in the
operation log, so that the data can be reviewed in an electronically managed state. In other words, metadata and operation records are
displayed in a visible form, so that they can be reviewed together with the analytical data.
LabSolutions is a trademark of Shimadzu Corporation.
Windows and Excel are trademarks or registered trademarks of Microsoft Corporation in the USA and other countries.
Preparation ofsamples
Implementation ofanalysis
Analysis conditionssettings
Instrumentparameters
Peak integrationparameters
Batchsettings
Breakdown of Other Reports• Instrument parameter reports• Data processing parameter reports• Calibration curve reports
Generation and storageof analytical data
Checker
Approver
Link(Between data to the Report Set)
Report Set
Operational log reports
Other reports
Chromatographyreports
Breakdown of the Report Set
Login
Inside the LabSolutions Database
Logout
Logout
Login
Logout
Login
Batch reports
Electronic signature
Electronic signature
Process Flowchart for Using LabSolutions DB/CS Report Sets
Note: LabSolutions DB/CS Report Set functionality is compatible with HPLC, GC, LCMS, UV, FTIR, and RF devices.
Note: Contact Shimadzu separately about the speci�cations and functionality of speci�c instruments related to strengthening data integrity.
For more information about Shimadzu solutions for strengthening
data integrity, go to the following website.
https://www.shimadzu.com/an/industry/pharmaceuticallifescience/fda.html
• Searches of reports and report generation
can be performed for each batch or each
data set, with reports saved in PDF format
in a database.
• Collecting the information automatically
helps avoid arbitrary report gathering and
operating errors.
• Data can be locked at the point it is
created to ensure the Report Set
includes the most recent data.
Check
Approval
Data integrity means the completeness of data. It expresses an assurance that all the data is included and that there are no inconsistencies.
LabSolutions DB/CS software enables compliance with data integrity requirements by providing a total system for managing analytical instruments
and test information in a single location. It not only improves the ef�ciency of testing processes, but also prevents data tampering.
Strengthen Data Integrity with LabSolutions™ DB/CS
Data integrity can be improved not only for chromatography and spectroscopy instruments, but also for analytical balances and various other
devices used in analytical laboratories.
Data Integrity for Various Analytical and Testing Instruments
From small standalone systems (devices and computers) to networked or cloud-based systems of large numbers of analytical and measuring
instruments, LabSolutions DB/CS can provide systems optimized for the given laboratory scale and form of operation.
Build a System Optimized for Each Specific Laboratory
Automate Report Creation
Excel® is often used for quantitative calculation of analytical data, but that could prevent obtaining correct results due to errors or alterations,
such as when transcribing analytical results, creating or storing Excel® �les, or printing or storing Excel® reports.
The multi-data report function in LabSolutions DB/CS can automate such processes and reduce the risk of errors and other problems. It can
also consolidate the data from different instrument types into a single report.
Manage Data Securely
Storing data �les, method �les, etc. in Windows® folders labeled with the
analyst's name or arranged by date can result in the following.
• Files could be deleted, copied, moved, or renamed.
• Original data or data from postrun analysis could be overwritten.
• Identically named �les could be saved in separate folders.
A system that provides highly reliable data, and prevents data tampering,
can be built by centrally managing the various data obtained from the
various analytical instruments in the laboratory in a LabSolutions DB/CS
database.
• Use a database to manage instruments, users, and analytical data.
• Projects can be created in the database, based on given operations.
Outline of the Multi Data Report Function
Using Projects to Manage Data More SecurelyUsing Projects to Manage Data More Securely
Management can be suited to tasks!
LabSolutions server
Project A
Access OKProject
Adata
Project B
Access OK
Project
Bdata
Authorization
Makes it more convenient to search for data,because only data from related projects is visible.
Managing User Operations (Processes) Appropriately
Data integrity requires not only restricting access to laboratory analytical instruments, but also assigning speci�c user privileges to analytical
laboratory personnel.
To ensure user privileges are speci�ed appropriately, visualize the work�ow by creating a process �ow chart and then use LabSolutions DB/CS
to register users and specify user privilege settings for implementing that work�ow.
Mr. A Mr. B Mr. C Ms. D Mr. E Ms. F
Routine Analytical Processes
Not received(returned)
Received(approved)
Not received(non-conforming)
ISystem Owner
IIProcess Owner
IIITest Manager
IVTest Assistant
VOperator
In Charge of InstrumentOperation and Testing
CoordinatesTesting Processes
ManagesTesting Operations
Manages SystemOperation
(manages LabSolutions)
Manages SystemInfrastructure
(manages computers)
Management Processes
Check and change operatingsystem settings
Check and adjust operatingsystem clock setting
Check and changeoperating system usersand user privileges
Check and changesecurity
Check and change usersand user privileges
Instrument connectionsettings
Backing up and restoring
Check and change projects (location for saving data)
Create report formats for Report Set
Create method �les
Create batch �les (sequence �les for executing a continuous series of analyses)
Repeat operations (postrun analyses, etc.)
Review Report Set
Start up instruments
(Make slight adjustments to methods)
Execute analyses
Con�rm analyses are �nished
Example of User Privilege Groups and Work�ow Recommended by LabSolutions DB/CS
Standardizing User Management and Deploying User Privileges for Other Instrument Types
In addition to LC and GC systems, analytical laboratories use UV, FTIR, ICPMS, and other types of instruments. However, the process of
managing the users of those instruments and assigning user privileges for each instrument type is extremely tedious and time-consuming. If
LabSolutions DB/CS is used, user management operations can be standardized for all instruments and user privileges speci�ed for LC or GC
systems can also be deployed for other types of instruments.
LC LCMSGC FTIRUV ICPMS
Chromatography-speci�c IR-speci�cUV-speci�c ICPMS-speci�c
CommonLabSolutions DB/CS
User Privileges
Contact Shimadzu separately about instruments not shown here.
LabSolutions DB/CS User Privileges
Data
Data 1 Data 2 Data 3
Conc.(mg/L)
Ave.(mg/L)
Report Template
Data 1 Data 2 Data 3
Conc.(mg/L) 3.019 2.998 3.011
Ave.(mg/L) 3.009
Create ReportLabSolutions DB
• Standard Function Support
• Create Reports
• Audit Trail Support
Template Editor
LabSolutions Database
Work�ow Example
Create and check Report Set
Data integrity means the completeness of data. It expresses an assurance that all the data is included and that there are no inconsistencies.
LabSolutions DB/CS software enables compliance with data integrity requirements by providing a total system for managing analytical instruments
and test information in a single location. It not only improves the ef�ciency of testing processes, but also prevents data tampering.
Strengthen Data Integrity with LabSolutions™ DB/CS
Data integrity can be improved not only for chromatography and spectroscopy instruments, but also for analytical balances and various other
devices used in analytical laboratories.
Data Integrity for Various Analytical and Testing Instruments
From small standalone systems (devices and computers) to networked or cloud-based systems of large numbers of analytical and measuring
instruments, LabSolutions DB/CS can provide systems optimized for the given laboratory scale and form of operation.
Build a System Optimized for Each Specific Laboratory
Automate Report Creation
Excel® is often used for quantitative calculation of analytical data, but that could prevent obtaining correct results due to errors or alterations,
such as when transcribing analytical results, creating or storing Excel® �les, or printing or storing Excel® reports.
The multi-data report function in LabSolutions DB/CS can automate such processes and reduce the risk of errors and other problems. It can
also consolidate the data from different instrument types into a single report.
Manage Data Securely
Storing data �les, method �les, etc. in Windows® folders labeled with the
analyst's name or arranged by date can result in the following.
• Files could be deleted, copied, moved, or renamed.
• Original data or data from postrun analysis could be overwritten.
• Identically named �les could be saved in separate folders.
A system that provides highly reliable data, and prevents data tampering,
can be built by centrally managing the various data obtained from the
various analytical instruments in the laboratory in a LabSolutions DB/CS
database.
• Use a database to manage instruments, users, and analytical data.
• Projects can be created in the database, based on given operations.
Outline of the Multi Data Report Function
Using Projects to Manage Data More Securely
Management can be suited to tasks!
LabSolutions server
Project A
Access OKProject
Adata
Project B
Access OK
Project
Bdata
Authorization
Makes it more convenient to search for data,because only data from related projects is visible.
Managing User Operations (Processes) Appropriately
Data integrity requires not only restricting access to laboratory analytical instruments, but also assigning speci�c user privileges to analytical
laboratory personnel.
To ensure user privileges are speci�ed appropriately, visualize the work�ow by creating a process �ow chart and then use LabSolutions DB/CS
to register users and specify user privilege settings for implementing that work�ow.
Mr. A Mr. B Mr. C Ms. D Mr. E Ms. F
Routine Analytical Processes
Not received(returned)
Received(approved)
Not received(non-conforming)
ISystem Owner
IIProcess Owner
IIITest Manager
IVTest Assistant
VOperator
In Charge of InstrumentOperation and Testing
CoordinatesTesting Processes
ManagesTesting Operations
Manages SystemOperation
(manages LabSolutions)
Manages SystemInfrastructure
(manages computers)
Management Processes
Check and change operatingsystem settings
Check and adjust operatingsystem clock setting
Check and changeoperating system usersand user privileges
Check and changesecurity
Check and change usersand user privileges
Instrument connectionsettings
Backing up and restoring
Check and change projects (location for saving data)
Create report formats for Report Set
Create method �les
Create batch �les (sequence �les for executing a continuous series of analyses)
Repeat operations (postrun analyses, etc.)
Review Report Set
Start up instruments
(Make slight adjustments to methods)
Execute analyses
Con�rm analyses are �nished
Example of User Privilege Groups and Work�ow Recommended by LabSolutions DB/CS
Standardizing User Management and Deploying User Privileges for Other Instrument Types
In addition to LC and GC systems, analytical laboratories use UV, FTIR, ICPMS, and other types of instruments. However, the process of
managing the users of those instruments and assigning user privileges for each instrument type is extremely tedious and time-consuming. If
LabSolutions DB/CS is used, user management operations can be standardized for all instruments and user privileges speci�ed for LC or GC
systems can also be deployed for other types of instruments.
LC LCMSGC FTIRUV ICPMS
Chromatography-speci�c IR-speci�cUV-speci�c ICPMS-speci�c
CommonLabSolutions DB/CS
User Privileges
Contact Shimadzu separately about instruments not shown here.
LabSolutions DB/CS User Privileges
Data
Data 1 Data 2 Data 3
Conc.(mg/L)
Ave.(mg/L)
Report Template
Data 1 Data 2 Data 3
Conc.(mg/L) 3.019 2.998 3.011
Ave.(mg/L) 3.009
Create ReportLabSolutions DB
• Standard Function Support
• Create Reports
• Audit Trail Support
Template Editor
LabSolutions Database
Work�ow Example
Create and check Report Set
Data Integrity C
ompliance in the A
nalytical LaboratoryC191-E047
Solutions Offered by Shimadzu Corporation
Data Integrity Compliance in the Analytical Laboratory
© Shimadzu Corporation, 2019First Edition: February 2019, Printed in Japan 3655-02902-20AIT
Reducing Potential Risks in Analysis/Postrun Work�ow - LabSolutions DB/CS Report Set
It is impossible to determine from looking at a chromatogram or other analytical data obtained whether or not the data was acquired using
correct test parameter settings (such as instrument or data processing parameter settings). Furthermore, the possibility of test parameters being
tampered with cannot be ruled out. However, LabSolutions DB/CS Report Set can be used to link analytical data with metadata (results from
parameter settings, data analysis, and other processes that involve human intervention) and with the entire series of actions recorded in the
operation log, so that the data can be reviewed in an electronically managed state. In other words, metadata and operation records are
displayed in a visible form, so that they can be reviewed together with the analytical data.
LabSolutions is a trademark of Shimadzu Corporation.
Windows and Excel are trademarks or registered trademarks of Microsoft Corporation in the USA and other countries.
Preparation ofsamples
Implementation ofanalysis
Analysis conditionssettings
Instrumentparameters
Peak integrationparameters
Batchsettings
Breakdown of Other Reports• Instrument parameter reports• Data processing parameter reports• Calibration curve reports
Generation and storageof analytical data
Checker
Approver
Link(Between data to the Report Set)
Report Set
Operational log reports
Other reports
Chromatographyreports
Breakdown of the Report Set
Login
Inside the LabSolutions Database
Logout
Logout
Login
Logout
Login
Batch reports
Electronic signature
Electronic signature
Process Flowchart for Using LabSolutions DB/CS Report Sets
Note: LabSolutions DB/CS Report Set functionality is compatible with HPLC, GC, LCMS, UV, FTIR, and RF devices.
Note: Contact Shimadzu separately about the speci�cations and functionality of speci�c instruments related to strengthening data integrity.
For more information about Shimadzu solutions for strengthening
data integrity, go to the following website.
https://www.shimadzu.com/an/industry/pharmaceuticallifescience/fda.html
• Searches of reports and report generation
can be performed for each batch or each
data set, with reports saved in PDF format
in a database.
• Collecting the information automatically
helps avoid arbitrary report gathering and
operating errors.
• Data can be locked at the point it is
created to ensure the Report Set
includes the most recent data.
Check
Approval
