C191-E047A

Solutions Offered by Shimadzu Corporation

Data Integrity Compliance

in the Analytical Laboratory
 Strengthen Data Integrity with LabSolutions™ DB/CS
Data integrity refers to maintaining data completeness, consistency, accuracy, and reliability throughout the product life cycle.
LabSolutions DB/CS software offers powerful support for ensuring compliance with data integrity requirements by
comprehensively managing analytical instrument information.

Strengthen Data Integrity for Various Instruments

LabSolutions DB/CS software enables stronger data integrity for all types of instruments in analytical laboratories, such as LC,
GC, LC-MS, GC-MS, UV, FTIR, spectrofluorophotometers, protein sequencers, ICP-MS, AA, EDX, thermal analyzers, particle size
analyzers, AG, TOC systems, Rigaku X-ray diffractometers and analytical balances.

Configure Systems Optimized for the Given Laboratory Size

LabSolutions DB/CS systems can be optimized for a wide range of laboratory sizes and operating styles, from small standalone
systems (with an instrument and computer) to networked or cloud-based systems with many analytical or measuring
instruments.

Managing Data Securely Commonizing User Management and User

Systems can provide highly reliable data, including preventing Privilege Settings for All Instruments
data falsification by using a LabSolutions DB/CS database to A wide variety of instruments other than LC and GC systems, such
centrally manage the data obtained from various analytical as LC-MS, GC-MS, UV, and FTIR systems, are also used in
instruments in the laboratory. analytical laboratories. Managing the users and user privileges for
all those instruments to ensure they are used appropriately is
• Instruments, users, and analytical data are managed in a
extremely tedious and time-consuming. LabSolutions DB/CS can
database.
reduce the time and trouble required for user management by
• Projects can be created in the database based on operating
commonizing the user management system for all instruments
practices.
and specifying all user privilege settings.

Security Policy Project A Project B Project C

Instruments
Security Policy

Instruments Users

LC01 LC02 GC03 UV01

Users User A User B User C

LC01 UV01
Group 1

User A User B User C User D User E

Database

Privilege Group User Group

Administrator Group 1

QC manager
Operator
 Managing User Operations (Processes) Appropriately
Data integrity requires not only restricting access to laboratory instruments, but also assigning specific user privileges to
laboratory personnel.
To ensure user privileges are specified appropriately, visualize the workflow by creating a process flow chart and then use
LabSolutions DB/CS to register users and specify user privilege settings for implementing that workflow.

Mr. A Mr. B Mr. C Ms. D Mr. E Ms. F

I II III IV V
System Owner Process Owner QC Manager Test Assistant Operator

Manages System Manages System Manages Coordinates Instrument

Infrastructure Operation Testing Operations Testing Processes Operation and Testing
(manages computers) (manages LabSolutions)
Management Processes Routine Analytical Processes
Workflow Example
Check and change Check and change Check and change projects (location for saving data)
OS settings security
Create report formats for Report Set
Check and adjust Check and change users
OS clock setting and user privileges
Create method files
Check and change Instrument connection
operating system users settings Create batch files
and user privileges (sequence files for executing a continuous series of analyses)
Backing up and restoring

Start up instruments

(Make slight adjustments to methods)

Execute analyses

Repeat operations Confirm analyses are finished

(postrun analyses, etc.)

Create and check Report Set

Review Report Set

Not accepted Not received Received

(returned) (non-conforming) (approved)

Example of User Privilege Groups and Workflow Recommended by LabSolutions DB/CS

Automating Report Creation

Spreadsheet software is often used, such as for quantitative LabSolutions Database
calculations of analytical data, but that can prevent obtaining Step 1 Select analytical results Step 2 Select template

proper results due to errors or alterations, such as when

transcribing analytical results, creating or storing files, or printing
or storing reports.
The multi-data report function can create reports for the selected
analytical results using the selected report template and then
Step 3 Create report
automatically create and save the report in the database. That
eliminates the need to transcribe data, reduces the risk of errors,
and can prevent data alterations or falsification. It also means
reports with a combination of LC, GC, MS, FTIR, UV, analytical
balance, and other instrument data can be created more
PDF

efficiently using three easy steps.

 Data Integrity Compliance in the Analytical Laboratory
Reducing Potential Risks in the Data Acquisition/Analysis Workflow - LabSolutions DB/CS Report Set
It is impossible to determine from simply looking at an acquired chromatogram or other analytical data whether the data was acquired
using correct test parameter settings (such as instrument or data processing parameters) or rule out the possibility of the test parameters
being falsified. Furthermore, log reviews are required to guarantee that electronic records do not include any fraudulent or suspicious data.
By using LabSolutions DB/CS report sets, analytical data can be electronically managed and linked to metadata (results from processes that
involve human intervention, such as specifying parameter settings or data analysis) and to the entire series of corresponding log data. In
other words, metadata, log data, and analytical data can all be reviewed within a single report. In addition, by specifying all log events that
should be reviewed in advance, all log events that need to be reviewed can be automatically extracted to enable efficiently checking for
fraud or suspicious content in log data. Additionally, when review records are signed, they can be linked to data as a log review report.
That means the entire series of process steps from data acquisition to data log reviews can be managed electronically.

LabSolutions Database

Generate/save
Execute analyses analytical data
Prepare samples

Login Logout

Link
Reviewer
Specify analytical (between data and the report set)
• Reports can be searched, created, and conditions
saved in PDF format in a database for Report set
PDF Login

Review
Instrument Electronic
individual batches or data sets. parameters signature
Report set contents Logout
• The information is gathered automatically
Peak Analysis list Approver
to help avoid report data from being integration Data reports
(batch report)
gathered arbitrarily and to avoid parameters

operating errors.

Approval
Log extraction Login
Log report Electronic
report signature
• Data can be locked at the point it is Batch
Logout
settings
created to ensure report sets include the
Other reports
most recent data. PDF

• Log review criteria can be specified to Contents of other reports Log review
• Instrument parameter reports report
eliminate dependence of review • Data processing parameter reports
standards on individual reviewers. • Calibration curve reports

• All log data that should be reviewed can

be reviewed at the same time to Proposed Process Flowchart for Using LabSolutions DB/CS Report Sets
significantly shorten review times.

Note: LabSolutions DB/CS report set functionality is compatible with all Shimadzu LC, GC, LC-MS, GC-MS, UV, FTIR, RF, SALD, TA, AG, TOC-L systems and Rigaku X-ray diffractometers.
Note: Contact Shimadzu separately about the specifications and functionality of specific 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/industries/small-molecule-pharmaceutical/data-integrity/index.html

LabSolutions is a trademark of Shimadzu Corporation or its affiliated companies in Japan and/or other countries.

For Research Use Only. Not for use in diagnostic procedures.

This publication may contain references to products that are not available in your country. Please contact us to check the availability of
these products in your country.
Company names, products/service names and logos used in this publication are trademarks and trade names of Shimadzu Corporation,
its subsidiaries or its affiliates, whether or not they are used with trademark symbol “TM” or “®”.
Third-party trademarks and trade names may be used in this publication to refer to either the entities or their products/services, whether
or not they are used with trademark symbol “TM” or “®”.
Shimadzu disclaims any proprietary interest in trademarks and trade names other than its own.

www.shimadzu.com/an/ The contents of this publication are provided to you “as is” without warranty of any kind, and are subject to change without notice.
Shimadzu does not assume any responsibility or liability for any damage, whether direct or indirect, relating to the use of this publication.

© Shimadzu Corporation, 2023 / First Edition: February 2019, 3655-02313-PDFIT, C191-E047A