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Caliber iLIMS-Features Flipbook PDF
Caliber iLIMS-Features
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CaliberiLIMS Laboratory Information Management System
For a Laboratory Par Excellence
About iLIMS ❑ Caliber iLIMS Seamless integration of Sample Workflow and Various Laboratory Instruments. ❑ This System is designed as per 21 CFR Part 11 Guild lines and other regulatory bodies. ❑ Digital signatures with date and time stamp for all registrations, review and approvals. ❑ Password policy and Role-based security configurations. ❑ Audit trail of all transactions with instrument usages and metadata.
❑ Instrument Interface with Port Based Systems (Balances , pH Meters) , File based Systems (UV , FTIR , AAS ) and CDS (Empower , Chromeleon, Lab Solutions and Open Lab). ❑ Electronic Worksheet and Online Results Recording. ❑ In-built Sample Management and OOS Workflows. ❑ Generation of Reports like COA , Raw Data , Investigation Log and Log reports.
❑ Instrument Management Module will tighten the Calibration Schedule , Recording and Instrument Usages. ❑ Configured COA Module Enables Users to generated the Market / Customer Specific COA’s. ❑ Reference Documents can be uploaded.
High Level Design (HLD)
Sample Login
Sample Acceptance
Sample Allotment
Analysis & Result Entry
Review & Approval
COA & Raw Data
Core Sample Life Cycle
Instrument Management
Caliber iLIMS
Masters (Central Master Preparation for all Products) System Manager (All Admin and Configuration Activities)
Salient Features Configured COA
Sample Management with built-in OOS Flow
Interface with Various Instruments Calibration Control
100 % Web Technology
iLIMS
21 CFR Part 11 Compliance
Object Model Workflow
Integration with Instruments
Autotitrators, AAS, ICP, Non-CDS Systems Etc
HPLC, GC & UPLC Integrated to CDS System
RS232 Port / TCP IP Monitoring File Parsing & Methods File Based Instruments
CDS System Direct Integration
SDK Integration Engine
Instrument Interface Table
Balance , pH Meter & Conductivity
Port Based Interface ❑ Port Based Instruments that outputs in a non-
RS232 Port to Ethernet Conversion
Central LIMS Server CaliberEDAP Web Service
file-based format through RS232 port.
CaliberEDAP Client Service
❑ These instruments can have the single value
Router Plant Specific – EDAP Service 1. EDAP Client 2. Device Installer 2. Com Port Redirector
Ethernet LAN
RS23 Port to Ethernet Convertor
❑ Port Based instrumentation is interfaced to
LAN Port
LAN Port LAN Connection
like pH meter or report attachment like dissolution apparatus.
Switch
LAN Connection
Power Unit for Convertor
RS23 Port to Ethernet Convertor
Switch
output like balance or multiple value output
Power Unit for Convertor
LIMS via a standard RS232 – TCP/IP connection through Ethernet convertor. ❑ The Ethernet Convertor is used to allow the
End User
PC-CaliberLIMS Balance Instrument Data Collection
pH Meter PC-CaliberLIMS Instrument Data Collection
End User
network connections to its ports to which the instruments can be connected via RS232 cable.
File Based Interface ❑ File Based Instrument Interface is a unidirectional PC Program Based Instrument Interface – Central Client
integration, with individual instrument interface
PDF Creator Service
of the file or PC program instruments and
PC Program Based Instrument LAN Connection
Central LIMS Server CaliberEDAP Web Service
Lab User Router
PDF Creator Server Instance
provide an option to pull the quantification values with the .pdf print Report.
PC Program Based Instrument
LAN Connection
Ethernet LAN
PDF Creator Service
❑ Instrument which is operated through computer LAN Connection
program (Non-CDS) and generates an output
Lab User
as a file or report falls under this category.
PDF Creator Service PC Program Based Instrument
❑ Examples of File Based Instruments are:
LAN Connection LAN Connection
Lab User
CaliberLIMS Client Review & Approval
❖ UV (Ultra Violet Spectrometer) ❖ FT-IR (Fourier Transform Infrared Spectroscopy) ❖ AAS-Atomic Absorbance Spectrometer
CDS Interface ❑ CDS Interface is a Uni-directional integration.
CDS Based Instrument Interface HLD
This interface shall provide an option to publish
Central LIMS Server CaliberEDAP Web Service
CaliberLIMS Access
the sample set from LIMS to CDS system and
Router CaliberLIMS Client Review & Approval
Switch
Ethernet LAN
❑ The CDS output results captured as a package
Switch
of both results data and report (as per
Network Network
CaliberLIMS Client Review & Approval
Network
Network
then pull the results from CDS to LIMS.
CaliberEDAP Interface Client *Dedicated CDS Client
template). Interface solution requires a single point integration with CDS (Through one of the
Network
Client). ❑ CDS (Empower & Chromeleon) interface is with Lab User
UPLC System
Lab User
HPLC System
Lab User
GC System
the SDK (Software Development Kit) toolkit, provided the system is in Client-Server model.
Object Model Workflow ✓ Configurable Electronic Signatures ✓ Number of Review/Approvals ✓ Transfer of Task ✓ Configurable levels of Review/Approval ✓ Built in Change management ✓ Audit Trails ✓ This object enables the auto-adherence to 21CFR Part 11 and cGMP needs.
Sample Workflow Sample Login
Samples can be logged as per User Sample Acceptance
requirement. All the Sample Details can be entered as
Sample Allotment
Analysis & Result Entry
per the Sample Type Configuration. Sample Inward Report and other reports
Review & Approval
COA & Raw Data
will be generated.
Sample Workflow Sample Login Sample Acceptance
Sample Allotment
Analysis & Result Entry
Review & Approval
COA & Raw Data
Tracking of the Sample with the details of who have received and when it has been received Sampling Rules, E-Sampling and Reduced Testing Rules will be available.
Printable reports and exportable to excel
Sample Workflow Sample Login Sample Acceptance
Sample Allotment
Analysis & Result Entry
Review & Approval
COA & Raw Data
Sample Assignment can be done based on the availability of the analysts. Configurable “Due Date for Analysis” during Allotment for each sample and Lab Performance reports
Sample Workflow Sample Login
Results Recording completely automated Sample Acceptance
by interfacing with the analytical instruments.
Sample Allotment
Analysis & Result Entry
Based on the calibration Status , the data can be collected from instruments. Easy to build validated formulae for
Review & Approval
COA & Raw Data
calculation.
Sample Workflow Thorough review process with detailed
Sample Login Sample Acceptance
Raw data which gives the complete information of
Sample Allotment
Analysis & Result Entry
analysis
including
the
usages performed Provision for sending back the data for Re-Analysis and Rechecking
Review & Approval
COA & Raw Data
Multiple levels of reviews, addressing OOS, OOT
Sample Workflow Sample Login Sample Acceptance
Controlled Copies of COA’s with electronic signatures Configurable templates for COA’s based on the material
Sample Allotment
Analysis & Result Entry
Review & Approval
COA & Raw Data
COA logs with detailed information on 4W’s(Who When Why What)
Instrument Management Instrument Management is crucial activity for any laboratory. This facilitates the asset management, calibration schedules, and maintenance of the calibration records with auto generated Reports. ❑ Instrument Registration with details like Make , Model , Serial No. , Expiry Date and Reference document upload related to instrument. ❑ Calibration Data Sheets and Types can be generated with calibration parameters, settings and the frequency of calibration for each instrument and module. ❑ All Calibration Schedules can be recorded for all Instruments and modules and monitored for failsafe implementation. ❑ Instruments will be available for Usage only after Calibration is completed ❑ Problem and Service Reporting, breakdowns and linked service reports can be formed.
Instrument Management If Calibration is pending / Under approval , the Instrument usages cannot be submitted.
Data Collection via Inst. Conn. Data Transfer Mode
Configured COA Configured COA Module Enables Users to generated the Market / Customer Specific COA’s. Generation of Configured COA and Compiled COA ❑ A Configured COA can be generated for an A.R. No. (whose Basic COA has already been generated), with the help of a selected Alias COA Template and Alias Test Plan, with an option to use a pre-registered Alias for the Product / Material. The fields concerned with the sample may be edited as desired. ❑ Test(s) may be deselected from appearance on the Configured COA. ❑ A Complied COA is a merged document, of several Configured COAs, that displays a combination of the selected test results that had 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 may 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 – COA Preview
❑
Configurable Task alerts Panel
❑
Configurable Quick Access Menu
Dashboards
Test Trend Analysis
❑ Calculation of Minimum Maximum and Average. ❑ Selection of Chart Type as per the need. ❑ Click on the Export To Excel to push the information into Excel Sheet. ❑ Print provision to print the Trend reports.
Object Model Workflow – Configurations
Object Model – Review and Approvals
Object Model – Modification Approvals
Electronic Worksheet or Test Data Sheet
Test Plan Controls & Configurations
Data sheet – Controls & Configurations
Audit trails & Data capturing
Raw data
Certificate Of Analysis - COA
Object Model workflow
Print Controls and logs
Upgrade path of Caliber iLIMS Enterprise
Standard Caliber iLIMS • Full Featured Sample Management • 21CFR Complaint
• Expandable to higher Version • Sample manger, system admin,
•
Full Featured Sample Management
•
Full Featured Sample Management for enterprise
•
21CFR Complaint
•
21CFR Complaint
•
Expandable to higher Version
•
Expandable to higher Version
•
Sample manger, system admin, Column, instrument module, Inventory, Stability
•
Enterprise architecture multiple plants
•
Centralized masters
instrument module
•
ERP integration
CaliberLIMS Standard Modules ❑
System Manager
❑
Configured COA
❑
Sample Manager
❑
Control Samples
❑
Reference Standards
❑
Label Management
❑
Working Standards
❑
LDMS
❑
Instrument Management
❑
Stability Management
❑
Column Management
❑
Analyst Qualification
❑
Volumetric Solutions
❑
Application Integration
❑
Chemical Management
THANK YOU
Caliber Technologies Pvt Ltd www.caliberuniversal.com