CaliberiLIM

ForSa Laboratory Par

Laboratory Information M a n a g e m e n t System
Excellence
 About iLIMS
 Caliber iLIMS Seamless integration of Sample Workflow a n d Various Laboratory Instruments.
 This System is designed as per 21 CFR Part 11 Guild lines a n d other regulatory bodies.
 Digital signatures with date a n d time stamp for all registrations, review a n d approvals.
 Password policy and Role-based security configurations.
 Audit trail of all transactions with instrument usages a n d metadata.
 Instrument Interfac e with Port Based Systems (Balances , pH Meters) , File b a s e d Systems (UV , FTIR , A A S
) a n d C D S (Empower , Chromeleon, Lab Solutions a n d O p e n Lab).
 Electronic Worksheet a n d Online Results Recording.
 In-built Sample Management a n d OOS Workflows.
 Generation of Reports like C O A , Raw Data , Investigation Log a n d Log reports.

 Instrument Management M o dule will tighten the Calibration Schedule , Recording a n d

Instrument Usages.
 Configured COA M od ule Enables Users to generated the Market / Customer Specific COA’s.
 Reference Documents c a n b e uploaded.
High Level Design (HLD)

Sample Sample Sample Analysis & Review & COA &

Login Acceptance Allotment Result Approval Raw Data
Entry
Core Sample Life Cycle

Instrument Management

Caliber Masters (Central Master Preparation for all

iLIMS
Products)
System Manager (All Admin and Configuration
Activities)
 Salient Features

Configured COA 100 % Web

Technology

Sample Management 21 CFR Part

with built-in OOS iLIM 11
Flow Compliance
S

Interfac e with Various Object Model

Instruments Workflow
Calibration Control
 Integration with Instruments

Balance , pH Meter
RS232 Port / TCP IP
& Conductivity
Monitoring

Instrument Interface Table

File Parsing
&
Autotitrators, AAS, Methods
ICP, Non-C D S File Based
Systems Etc Instruments

HPLC, G C &
CDS System
UPLC Integrated SDK Integration
Direct Integration
to C D S System Engine
Port Based Interface
RS232 Port to Ethernet
Conversion
 Port Based Instruments that outputs in a non-
Central LIMS Server file-based format through RS232 port.
CaliberEDAP Web CaliberEDAP Client
Service
Service
 These instruments c a n ha ve the single value
Router
Plant Specific – EDAP
Service
1.EDAP Client
2.Device Installer
output like balance or multiple value output
2. Com Port
Redirector like pH meter or report attachment like
Ethernet
Switch
LAN
Switch
dissolution apparatus.
LAN
Port
LAN
Port
 Port Based instrumentation is interfaced to
Power Unit
R S 2 3 P or t to Ethernet

Power Unit LAN

RS 2 3 Por t to Ethernet
LAN
LIMS via a standard RS232 – TCP/IP connection
for Connection for
Connection Convertor
C o nv e r t o r

Convertor

C o n v e rt o r
through Ethernet convertor.
 The Ethernet Convertor is used to allow the
pH
End
User
PC-CaliberLIMS
Instrument Data
Balance End User PC-CaliberLIMS
Instrument Data Meter network connections to its ports to which the
Collection Collection

instruments c a n b e connected via RS232

cable.
 File Based Interface
 File Based Instrument Interface is a unidirectional
PC Program Based Instrument Interface – Central Client

PDF Creator Service

integration, with individual instrument interface
PC Program Based Instru

LAN
of the file or P C program instruments a n d
Connection

Lab User
Central LIMS Server
CaliberEDAP Web Service provide an option to pull the quantification
Router PDF Creator Server Instance values with the .pdf print Report.
PDF Creator Service

PC Program Based Instrument

Ethernet LAN  Instrument which is operated through computer
LAN
Connection LAN

program (Non-CDS) a n d generates an output

Connection

Lab User

PDF Creator Service

as a file or report falls under this category.
PC Program Based Instrument
LAN
Connection
 Examples of File Based Instruments are:
LAN

 UV (Ultra Violet Spectrometer)

Connection

Lab User
CaliberLIMS Client
Review & Approval

 FT-IR (Fourier Transform Infrared

Spectroscopy)
 AAS-Atomic Absorbance
Spectrometer
 C D S Interface
CDS Based Instrument Interface  C D S Interface is a Uni-directional integration.
HLD

Central LIMS Server

This interface shall provide a n option to publish
CaliberEDAP Web CaliberLIMS
Service Access
the sample set from LIMS to C D S system an d
Router
CaliberLIMS Client
Review &
Approval
then pull the results from C D S to LIMS.

Switch Ethernet Switch

 The C D S output results captured as a p a c k a g e
LAN

Network
Network Network
of both results data and report (as per
CaliberLIMS Client
Review & Network CaliberEDAP Interface Client
template). Interface solution requires a single
Approval *Dedicated CDS Client

point integration with C D S (Through one of the

Network

C lie nt).
 C D S (Empower & C hromeleo n) interface is with
Lab User Lab User Lab
User the SDK (Software Development Kit) toolkit,
UPLC HPLC System GC
System
provided the system is in C lie nt-Server model.
O b jec t Model
Workflow
 C o nfig ura ble Electronic Signatures

 Number of Review/Approvals

 Transfer of Task

 C o nfig ura ble levels of Review/Approval

 Built in C h a n g e m a na g em e nt

 Audit Trails

 This o b je c t enables the auto-

adherence to 21CFR Part 11 a n d c G M P

needs.
Sample Workflow

Sample
Login  Samples c a n be logged as per User
Sample
Acceptance
requirement.

Sample
Allotment
 All the Sample Details c a n be entered as
Analysis
& Result
Entry per the Sample Type Configuration.

Review &  Sample Inward Report a n d other reports

Approval

COA &
Raw will b e generated.
Data
Sample Workflow

Sample
Login  Tracking of the Sample with the
Sample details of who h a v e received a n d
Acceptance
when it has been received

Sample
Allotment
 Sampling Rules, E-Sampling a n d
Analysis Reduced Testing Rules will
& Result
Entry available. b e

Review &  Printable reports a n d exportable to

Approval
excel
COA &
Raw
Data
Sample Workflow

Sample
Login  Sample Assignment can be done
Sample based on the availability of the
Acceptance
analysts.

Sample  Configurable “Due Date for Analysis”

Allotment
Analysis during Allotment for e a c h sample
& Result
Entry
a n d Lab Performance reports

Review &
Approval

COA &
Raw
Data
Sample Workflow

Sample
Login
 Results Recording completely automated
Sample
Acceptance
by interfacing with the analytical

Sample
instruments.
Allotment
Analysis  Based on the calibration Status , the data
& Result
Entry
c a n b e collected from instruments.
Review &  Easy to build validated formulae for
Approval

COA & calculation.

Raw
Data
Sample Workflow

Sample
Login  Thorough review process with detailed
Sample
Acceptance Raw data which gives the complete
information of analysis including the
Sample
Allotment usages performed
Analysis
& Result
Entry  Provision for sending b a c k the d a t a for

Review &
Re-Analysis a n d Rechecking
Approval
 Multiple levels of reviews, addressing
COA &
Raw
Data OOS, OOT
Sample Workflow

Sample
Login  C o ntrolled Copies of C O A ’ s with
Sample
Acceptance
electronic signatures

 C o nfig urab le for C O A ’ s

Sample
Allotment templates
Analysis
& Result b a s e d o n the material
Entry
 C O A logs with detailed information
on 4W’s(Who When Why What)
Review &
Approval

COA &
Raw
Data
 Instrument M a n a g e m e n t
Instrument M a n a g e m e n t is crucial activity for any laboratory. This facilitates the asset management,

calibration schedules, a n d maintenance of the calibration records with auto generated Reports.

 Instrument Registration with details like M a k e , Model , Serial No. , Expiry Date a n d Reference

docum ent upload related to instrument.

 Calibration Data Sheets a n d Types c a n b e generated with calibration parameters, settings and

the frequency of calibration for e a c h instrument a n d module.

 All Calibration Schedules c a n b e recorded for all Instruments a n d modules a n d monitored for fail-

safe implementation.

 Instruments will b e available for Usage only after C a libra tio n is completed

 Problem a n d Service Reporting, breakdowns a n d linked service reports c a n b e formed.

Instrument M a n a g e m e n t

If C a libra tio n is
pending / Under
approval , the
Instrument usages
cannot b e submitted.

Data C o lle c tio n

via Inst. Conn.
Data Transfer M o d e
 Configured C O A
Configured C O A M od ule Enables Users to generated the Market / Customer Specific COA’s.

Generation of Configured COA and Compiled COA

 A Configured C O A c a n b e generated for an A.R. No. (whose Basic C O A has already been
g e ne ra te d ), with the help of a sele c te d A lia s C O A Tem pla te a nd Alia s Test Pla n, with an
o p tion to use a p re -re g iste re d A lia s fo r the Pro d uc t / M a te ria l. The fields c onc e rne d with the
sam p le m a y be e d ite d as d e sire d .
 Test(s) m a y b e deselectedfrom a pp earance on the Configured C O A.
 A C om plie d C O A is a merged document, of several Configured COAs, that displays a
combination of the selected test results that h a d appeared on the constituent Configured COAs,
generated for the A.R. Nos. of samples of the same Batch No. of a Product / Material, on which
different tests m a y have been conducted individually or independently, but under the same Test
Reference.
Caliber iLIMS – Home
Screen

 Dashboards

 Quick Essentials – Results Entry

 Quick Essentials – Sample Status

 Quick Essentials – C O A Preview

 Configurable Task alerts Panel

 Configurable Quick Access M e nu

Dashboards
Test Trend Analysis

 C a lc ula tio n of Minimum

Maximum and
Average.

 Selection of Chart
Type as per the need.

 C lic k on the Export

To Excel to push
the information into
Excel Sheet.

 Print provision to print

the Trend reports.
O b je c t Mo d e l Workflow –
Configurations
O b ject Model – Review a n d
Approvals
O b ject Model – Modification
Approvals
Electronic Worksheet or Test Data Sheet
Test Plan C o ntrols &
Configurations
Data sheet – C o ntrols &
Configurations
Audit trails & Data capturing
Raw data
Certificate Of Analysis - C O A

O b je c t Model
workflow
Print Controls a n d
logs
 Upgrade path of Caliber iLIMS

Enterprise
Standard
Caliber  Full Featured  Full Featured Sample
• iLIMS
Full Featured Sample Mana geme nt for enterprise
Sample Management  21CFR C o mp la int
Management
 21CFR C o mp la int  Expandable to higher
• 21CFR C o mp la int
 Expandable to Version
• Expandable to higher  Enterprise architecture
higher Version Version multiple plants
• Sample manger,  Sample manger, system  C entralized masters
system admin, admin, C olumn,
instrument module instrument module,
Inventory, Stability
 ERP integration
 CaliberLIMS Standard Modules

 System Ma n a g e r  Configured C O A

 Sample Ma n a g e r  Control Samples

 Reference Standards  Label M a n a g e m e n t

 Working Standards  LDMS

 Instrument Ma n a g e m e n t  Stability M a n a g e m e n t

 Column Ma n a g e m e n t  Analyst Qualification

 Volumetric Solutions  Application Integration

 Chemical M a n a g e m e n t
THANK
YOU

Caliber Technologies Pvt

Ltd
www.caliberuniversal.com