2019/9/24

LABSOLUTION CS

Alfian Mauluddin
Sales Engineer
PT DITEKJAYA
SHIMADZU

Industry Key Focus - Today

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Data Integrity & Compliance

 Laboratory Workflows (Samples, Analysis, Reports & Approvals)

 Standard Operating Procedure (Every activity in the laboratory)

 Equipment Management (Calibrations, Maintenance, Usage Log, etc..)

 Accuracy of Data & Results

 Data Life Cycle (Protection & Retention)

 Quality Assurance Management

 Training Management

 Computerized System Validation (CSV)

Pharmaceuticals – Regulations & FDA

U.S Food and Drug Administration

Pharmaceutical Inspection
Co-operation Scheme

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SHIMADZU
Informatics Solutions

LabSolutions Product Series & LIMS Connectivity

LabSolutions Workstation LabSolutions Database LabSolutions Network

 Stand-alone Software  Stand-alone Software  Client/Server Software

 Flat-File System Storage  Database Storage in Local  Database Storage in Server

PC PC
 Windows File/Folder
Security  Project/User Level Security  Project/User Level Security

 Results export to  File/Folder Sharing for LIMS  File/Folder Sharing for LIMS
ASCII/TEXT Formats Connectivity Interface

 File/Folder Sharing for LIMS  SDK Interface for LIMS  SDK Interface for LIMS
Interface Connectivity (Optional) Connectivity (Optional)

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Shimadzu Informatics Solutions

Business Partnership

LabSolutions CS LIMS | QMS | DMS | EBR

Universal Network Platform End-To-End Laboratory Solutions

SHIMADZU – THE DIFFERENTIATOR

LABSOLUTIONCS SHIMADZU
Chromatography, Spectrometry & Mass
Spectroscopy Data System

Controls HPLC, GC, UV, FTIR, RF, LCMS, ICP-

MS, PPSQ Instruments & Data Management of
other Shimadzu & other vendor Instruments

Agilent LC/GC Control (Multi Vendor Control)

A Complete LIMS System with Easy

Expandable Options

Seamless Interface with LabSolutions CS,

Business Partnership Empower, Chromeleon & OpenLab Software

Enterprise-wide Paperless Laboratory Solutions

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LabSolutions CS – Total Laboratory Network

Client PC Client PC Native LabSolutions: Direct Connection:

LabSolutions
Server
Operations from Client PC Operations from Instrument’s
are available. PC are available.

RF
UV
PPSQ TA

LCMS LC GC Agilent LCAgilent Thermo Thermo

GC LC GC ICP-MS FTIR Balance

GCMS TOC SALD AA Other

EDX CBM-
Company’s
201ｍ
LC ＆ GC
Will support native mode Indirect Connection Via Text file:
Only for Data Management in server
Only for Data and User Management in server

Spectro Networks – Latest Demand

World’s only network for Spectroscopy & Chromatography Systems

 Peringatan FDA pada

instrumen Non-
Chromatography

 UV & FTIR dianggap sistem

yang kritis

 Mudah dimanipulasi dan

kontrol yang kurang

 Permintaan yang tinggi dari

pharmasi

 Data integrity alat non

kromatografi

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LabSolutions CS Improvements in 2019

LabSolutions CS Stability Improvements

300 Instruments - 5000 Projects - 1000 Users - 25Million Data Files - 65Million Logs

Direct Connection of Instruments

[LC-40 / SCD-2030 / DSC / AIM / SALD]
LabSolutions AA – Sep’19 | LabSolutions GCMS – Feb’20

Automated IQOQ [A-IQOQ]

Load and record E-format IQ/OQ inspections
Execute automatic OQ inspection
Transcript OQ inspection results
Register inspection reports with database
eIQOQ License for each PC is necessary

Part 11 Criteria & Controls

 Functional Specifications
 Design Specifications
 Data Availability  IQOQ
 Automatic Backups Validation
 PQ/Challenge Tests
 Easy Retrieval
 Disaster Recovery Management
Human
Backup &  PC Controlled Instruments
Readable
Restore  RAW Data
Output
 Replacement for handwritten sign  Meta Data
 Multiple Levels of Authorization  Reports
 Signature Controls
 Paperless Environment
Part 11  Password Policies
 User Policies & Rights
ER/ES Security &  Security Controls
Electronic  PC Controls
Access
Signatures
Controls

 Prevents Overwriting  Capture every change in Data

 Availability of Raw Data Version  Who-When-What-Why
 Capture data for every change Audit Trails  Analysis Operations
Controls
 File History  Instrument Activity Logs

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eIQOQ for LabSolutions CS Validation

 eIQOQ License is necessary for each PC [Server-Acq-Client]

 Additional License from Instrument for CS Connectivity

LabSolutions CS – Data Integrity Attributes Validation

 Functional Specifications
 Design Specifications
 IQOQ
 PQ/Challenge Tests

Print System Information window Print Computer Information window

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Access
LabSolutions CS – Data Integrity Attributes
Controls

 Access to System is controlled by User Operation Authority.

Strong security by Access Control
 Password Policies
 User Policies & Rights
 Security Controls
 PC Controls

Audit
LabSolutions CS – Data Integrity Attributes Trials
 Capture every change in Data
 Who-When-What-Why
 Analysis Operations
 System Records Automatically Who, What, When did.  Instrument Activity Logs
 Change Parameter and Reason of Change are Recorded when Parameter is changed.

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Audit
LabSolutions CS – Data Integrity Attributes Trials
Security Policy Settings – Version Controls & Audit Trails

LabSolutions CS – Data Integrity Attributes

Audit Trail Review – Log Browser Enhancements
 Easy to search of “Audit Trail Reason” in Log
Brower

 Audit Trail Review has became important for

Pharma customer

 Possible to search by Data/Batch/Method/System

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Version
LabSolutions CS – Data Integrity Attributes
Controls

Version
LabSolutions CS – Data Integrity Attributes Controls

 Audit trail for Data, Method, Batch, Report files

 Audit trail for System Configuration, System Policy, User Administration
 Versions for Data, Method, Batch, Report Data Versions

Audit Trails

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LabSolutions CS – Data Integrity Attributes

 LabSolutions gives an ID for uniquely identifying to all methods.
 The ID used throughout the sample set is able to confirm on the same window

This is an ID for specifying

integration events. This integration
events include parameters such
as “Width” , “Slope”, and “Time
Program” etc. This ID is updated
when each parameter is changed.

“M” mark is displayed in the

column of “Manual Integration” for
the data with manual peak
integration. It is easy to find the
data with manual peak integration.

* The title name of the column can be

customized

Electronic
LabSolutions CS – Data Integrity Attributes Signatures

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Electronic
LabSolutions CS – Data Integrity Attributes Signatures

 Multiple Levels of E-Sign & Data/Method/Batch Locking Mechanism

 PDF Signature & Link with Electronic Data

LabSolutions CS – Data Integrity Attributes

- It is possible to set up anywhere on the report
- It is possible to reconfirm the confirmation result at any time.

Report Confirmation Signature

 Since confirmation result record is recorded

in PDF, the stricter confirmation than paper
based operation is possible.
 By using with Report Set, the paperless
operation can be performed smoothly.

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LabSolutions CS – Data Integrity Attributes Data

Security

Security, data management by Project Environment

Projects-Users-Groups-Rights-Instruments
the whole system User
Security Policy Setting of Project
User A User B User C User D
Project
User E User F
Project registered user
User groups 1 Data
User groups 1
User A User B User C User D
User E Reviewer User A User B User C User D
Operator Operator Operator Operator Reviewer Reviewer Reviewer
Operator Operator Operator Operator

Security Policy
Instrument
Setting of Project
LC1 LC2
LC1 LC2 LC3 LC4

LabSolutions CS – Data Integrity Attributes Data

Retention
 Easy Operation by Backup and Restore tools
 Not only Analytical Data but also Log are Backed up.
 Backup Data can be Referred directly by Data Browser.

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LabSolutions CS – Data Integrity Attributes

 Single Report with Data, Method and Sequence Logs
 1 Click – 1 Document – 1 Print – 1 Signature
Report Set
 Auto-Lock of Data Files after report generation

Shimadzu LabSolutions CS Features

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LabSolutions CS Features
 The operating status of all instruments on the network can be confirmed.
⇒ Information such as system status, operator name and the analysis
end time are displayed in LabSolutions Launcher

LabSolutions CS Features
LabSolutions Server: Correspondence at failure
Analysis instrument room or cabin

Terminal Server
Client PC LabSolutions Server PC

LAN Connection

Possible to analyze it by the

acquisition PC.

Acquisition PC

GC LC GC LC

LC LC LC LC

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Enhanced Functions for UV/FTIR/RF

LabSolutions CS Balance Driver

 Create a template file for weighing

 Connect to balance and start weighing

LabSolutions Balance Weighing screen

 Weight data would be registered to

LabSolutions database automatically.
 The results could be also confirmed
on DataManager application.

LabSolutions DataManager

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LabSolutions CS Balance Driver

 Calibration starts by clicking “Calibrate”

button

 Calibration results would be registered to

LabSolutions Database

 Logs are registered to LabSolutions

LogBrowser application

LabSolutions LogBrowser

LabSolutions CS Balance Driver

Editing batch table screen on LabSolutions

Clicking ‘Balance Weight Setting’ button and then weight results list on LabSolutions
database would be displayed.

The list of Weight Data Weight Data could be imported into batch table

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LabSolutions UV
 Seamless connection to LabSolutions
 Integrated Data & User Management

LabSolutions IR
 Seamless connection
 Integrated Data & User Management

LabSolutions Main

Login

Launcher

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Column Management Features

Multi Data Report

 Automatic Custom Calculation Reports

 Feature of Multi Data Report

 Easytemplate creation and mitigation of the effort at Excel use
 Report of various equipment is possible only at LabSolutions

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Multi Data Report

 No external software, No Copy & Paste
 Change control of report template is easy.
 Report using various equipment’s data
 HPLC, GC, MS, FTIR, UV, and balance etc.

Client Client
LabSolutions
Server

Acquisition Controller Acquisition Controller

(ACQ) (ACQ)

LC GC LC LC UV Blance

Agilent LC/GC Control

 Mutual control based on driver exchange agreement with
Agilent Technologies Inc.

Select Edit method

Agilent LC/GC

Edit batch
table

Monitorin
g

Main

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LabSolutions CS - Analysis Automation

Automatic Smart
System Preparation Automation Kit

Auto Startup QC Automation

Auto Purge 4-Solvent, 6-column switching
Multi-method walk-away
Baseline Check automation
Sample Measurement R&D Automation
Auto Shutdown 7-Solvent, 6-Column Switching
Method Scouting

CSV (Computerized System Validation) Support

 GAP Analysis & URS

 Server, PC & Network Requirements

 Whitepaper on LabSolutions CS

 Qualification Documents (DS/IQ/OQ/PQ)

 Compliance Certificates

 SOP Documents

 User Trainings

 Regular Maintenance

We are not only providing network system

but also giving all services to be necessary
for regulatory compliance

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Advanced & Affordable IT Solutions

 Windows Terminal Services & Thin Clients

 Launch LabSolutions from Web Browsers (IE, Chrome, Firefox)
 VMWare & Citrix Platform to use IPad, Apple & Android Mobiles
 Disaster Recovery Tests

Advanced & Affordable IT Solutions

CS Server
Client PC Client PC Client PC Client PC

VPN

Acquisition Controller PC REMOTE

LOCATION
Acquisition Controller PC
Data Review Only

LC LC LC GC UV FT-IR

LCMS/MS AA Testing TOC Balances

Machine

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Advanced & Affordable IT Solutions

CS Server Remote Desktop
Client PC PC Client PC Client PC

Remote
Desktop

Acquisition Controller PC
REMOTE
Acquisition Controller PC LOCATION

LC LC LC GC UV FT-IR

LCMS/MS AA Testing TOC Balances

Machine

Shimadzu Biosphere

LIMS QAMS DMS Training BRMS

iLIMS

Caliber eDashboard

CLASS CLASS

3rd Party
Empower Software
Non-PC
Chromeleon
Instruments

LabSolutions CS

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SHIMADZU

ESTEEMED CUSTOMER BASE

Thank you

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Brand Statement "Excellence in Science"

We in the Shimadzu Group have delivered products and services to enable our customers around the world to develop a diverse
range of new products, to protect and improve the environment, and to improve the health and lives of mankind. This brand
statement represents our sense of pride in this endeavor. It is our commitment to society and ourselves that Shimadzu remains
dedicated in our pursuit of technology and accumulation of knowledge, so that we can offer even more outstanding technologies,
products, and services, so as to be recognized for excellence in the field of science.

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