Transcript Caliber Pet
Deliver More … Deliver Excellence!
Pittsburgh, PA. USA
About Caliber
Caliber is a company focused on IT
solutions for Laboratories Specially
GLP/GAMP compliant.
Established in the year 2001
Global Marketing HQ at Pittsburgh USA
ISO 9001-2000 Certified
Well organized Development process
Absolute leadership in Indian Pharma
Industry
Best Product Award winner--- from HYSEA
CIO 100 Asia, best project award winner
CaliberLIMS® Industry Verticals
Pharmaceuticals Manufacturing QC
Research & Drug Development
Petrochemicals
Water & Environment
Food Testing
Public health
Training Management in GMP
Recognition
Product — Hysea & Site approvals
Project Management- CIO Asia
Award
Company- Deliotte Asia Award
Team -- Entrepreneur of the year
More important than all the above:
Repeat orders
A Few of Our Valued Customers…
CaliberLIMS®
Wyeth
Mylan India (Matrix)
Fresenius
Dr. Reddy’s Ltd (5)
Aurobindo (3)
Unichem
Medicap - Thailand
Panacea
BPCL (25)
Dabur UK
JBCPL (8 Plants)
Zydus Hospira
Sanofi Aventis
Divis Laboratories Ltd
Ajanta Pharma
Repeat Orders Speak Volumes!!
Pharma Industry
……. The Journey
Pharma Industry Journey !
Safe Medicine
Final Drug
Testing
1960
Testing every
component in the
process
ICH
Harmonization
2003
PAT
Future
More controls & Huge data
Increased work load
V1
•100X analysis
RM2
V2
V3
•Vendor audits
V1
Final
drug
testing
Final
drug
Release
RM2
V2
•Process audits
•Validations
V3
•Qualifications
V1
RM2
V2
V3
•Annual reports
•OOT
FDA 483s - Quality and
Laboratory
Observation Rates
483Issues
for ALL Systems
Feb. - July, 2002: 216 inspections: 2,221 observations
Other
3%
Quality
20%
Laboratory
21%
Packaging/
Labeling
5%
Production
18%
Facilities/
Equipment
21%
Material
12%
Common Lab Errors, Common
Root Cause
Transcription Errors-- Major
Contributor
Calculation errors Lack of Information
Insufficient Training
Improper Review
Lack of Controls
FDA 483s –
Quality and Laboratory Issues
LABORATORY System
483 Observation Rates:
Inadequate
Records/SOPs
27%
Feb.- July, 2002: 216 inspections; 477 observations
Controls General
35%
Training/Qual.
4%
Stability Program
21%
Methods
Validation
13%
How will LIMS help you!!
What is in it for Me??
Clear job Description
Great reduction in errors, LIMS is
Error prevention system !!
Quicker completion of the job..
- Deliver More!
Automatic Adherence to the Quality
System like ISO17025
- Deliver Excellence!
Front Desk:
Chemist
•No Registers
•My jobs- List
Lab Head
Management
•On-line Review •On-line
of result & raw approval
•Click &
•Clear worksheet
data
Select Sample
• Sample
•No Calculations
Registration
•Lab Sample
Status of all
•All Support
Status
the labs
•Automatic
Documents
Costing /Billing
•Work load
•Risk
available on click
Calculation
Management
•Sample Status
•Lab inventory
•Various
report
Solution … CaliberLIMS
Fully web-based, .NET technology
N-tier architecture, modular design
Easy integration with ERP (certified SAP
integration)
Easy to implement, Easy to use
Requires minimal customization, out of
the box
Model based: Requires minimal training,
Meets/exceeds Regulatory requirements
of FDA/ MHRA
Webservices & XML based engines
Why CaliberLIMS ?
Why Caliber LIMS
Technology: On web technology since
Year 2001
Good value proposition
Robust Framework
GAMP compliant implementation process
Short Learning Curve
Proven Track record through successful
international regulatory audits
Product Technology - Benefits
CaliberLIMS 3.X.X is built on Microsoft .Net
Technology Built on n-tier Technology web Technology.
Choice of DB MS SQL or Oracle
100 % Browser based client operations
Specially designed OOPS model for regulated
industry.
Highly stable and leading Microsoft
Architecture.
Technology Benefits
Highly scalable application.
Lesser maintenance.
Lesser Validation burden.
Lower cost of ownership.
Easier Upgrades.
Shorter Learning curve.
Quick ROI.
…… Hence it is a preferred product!!
CaliberLIMS Features
End- to - End Lab Management Solution
Easy to Master configurable workflows
Shorter Learning Curve
Highly modular, hence implementation can
be staggered, if desired.
Comprehensive functionality to address all
common lab practices, see it to believe it !
Configurable enforcement of GLP/FDA
norms
Reports to address all needs of Lab
Management
Compiled
COA
Configured
COA
Working
Standards
Media
Management
LDMS
Control
Samples
Sample
Scheduler
Inventory
Management
Columns
Management
Culture
Management
Application
Integration
Instrument
Data
Acquisition
Competency
Management
Label Prnting
Instruments
Manager
Training
Scheduler
Market
Complaints
Change
Management
Messaging
alert Services
Independent
functional
Modules
Quality
Assurance
Audit
Management
ERP
Sample
Management
Deviations
Active
Directory
SDMS/ECM
Extended
Sample
Management
Chemical
Manager
Volumetric
Solutions
Report
Builder
Analyst
Qualification
Environment
Management
Stability
Manager
Application
Admin &
Security
Man
4 M Rule
Machine Material Method
Sample Manager
……..Workflow
Sample Allotment :
•Can assign all tests in
a sample to one person
(SI, Sample in-charge)
• Allotment by Test
category (TCI) to more
than one analyst
• Allotment by Test
(TI) to more than one
analyst
•SI TCI TI
Approval Process:
TITCISIMGR
more levels of
approvals on
Demand:
Task Center….One click approach
Sample Status
------- Dash boards
---- Status at a glance
…… Click on the desired segment to see further information .
Configurable Home page analytics
•Dashboards
•Quick Sample status
•Quick result entry page
•Quick COA view page
•Configurable Task alerts panel
Trends of any test.. On click
Analyst Performance
& Service levels
Sample Manager Demo
Configurable Print Controlled
worksheets.
Configurable & version controlled COA
•Easy point and click
design
•Version controlled and
old reports are not
affected by the current
changes
•Print control available
•COA compliant to ER
& ES rules.
Technical Benefits
CaliberLIMS Framework
CaliberLIMS has been repositioned as
an Enterprise Quality Management
Frame work rather than just a LIMS
It is a one place to manage all
laboratory functions sitting right at
one desktop
Application integration is an
important aspect of LIMS 3.x.x
Integration is everything !!
Flexible Framework for an integrated approach !!
Application integration
CaliberLIMS can be integrated with
applications like:
ERP like SAP
MES
Historians
Instrument Interface tools
Report Generators
Functional Benefits
High Value addition optional Modules
1.
2.
3.
4.
5.
6.
7.
8.
Chemicals Management
Working Standards
Ref. Standards
Volumetric Solutions
**Analyst Qualification
Training Management
Column Management
**Instrument Calibration
Mgmt.
9. **Stability Management
9. Microbiology Culture
Management.
10.Media Management
11.Label Printing.
12.Lab DMS.
13.Market Complaints.
14.Change Management.
15.Deviation Management.
16.**Outsourcing/ Reduced
testing.
17.Lab Costing Module
Just Not Inventory Modules…
….Much more than that !!
Working Standards
1. Get the material Get it analyzed by 3-4
analysts check RSD if OK approve the
material
2. Distribute the material in to bottles (may be one
every month)
3. Use bottle after bottle
4. Usage tight integration. i.e unless the usage is
recorded, result confirmation is not possible
5. Maintain consumption records for all the bottles
(stock cards)
Instrument Management :
Asset information like..
History
Calibration scheduling, Calendar
Calibration Certificate generation
Maintenance tracking, trend analysis.
Problem reporting
Service logs
Internal,external calibration tracking
Calibration data storage
Hyperlinks to Validation or SOP docs
Volumetric Solutions:
Prepare- by using Templates for the
variable quantity
Standardize
Schedule a re-standardization time
Get alerts
Record Usage
Usage throuh tight Integration
Chemical Reagent Preparation and Inventory
Template for Reagent Preparation for
a standard volume of reagent
Prepare reagent within tolerance
limits
Record the usage
Get Stock cards, inventory alerts and
validity alerts
Configured COA: Unique Feature !
Problem: You have tested a material batch with in-house
specifications and you want to release the COA with a
different specifications with the same test results.
Solution: Release differently configured COA without
altering the results and AR no under strict regulatory
guidelines
Analyze the batch (Bulk FP)
Release with
Different Spec Description
Different Customers
Different Packing types
May be Different Language
…..Everything Under strict regulatory guidelines and audit
trails.
Compiled COA : Unique Feature !!
Problem: You have analyzed a batch earlier with
10 tests, now customer wants one more test to
be conducted and a new COA released.
Solution: Just conduct the new test and combine
the earlier test results and the new one and
release COA within regulatory guidelines
Do additional testing
Add additional testing to the existing analysis
Release the COA
Keep track of all such releases
Control Sample Management
Keep track of the samples which need to
stored.
Record: Storage place, Quantity,
conditions.
Pull the sample through a Requestapproval process
Re-keep the un-used sample
Get alerts for Sample disposing
Reports: Stock, withdrawal, distruction
Stability Studies Management
Stability Protocol
Dedicated Module to Manage complete
Stability Studies.
A stability Protocol can be registered with
all the necessary details like:
Different Conditions with independent set
of tests.
No. of Pulls per condition.
Associated details of a condition and
study.
Can be implemented as Stand alone
stability Management System
Stability Protocol Registration
A Product/ Material can have multiple
storage conditions
Each Storage Condition can have
multiple Sample pull frequencies
registered
For Each condition tests to be carried
out can be selected.
Up on completion of the sample
approval, trends can be obtained
Stability Protocol
Stability protocol registration is highly
configurable to have various input fields
relevant to the study.
User configurable to all types of
products/Materials like: Finished Products.
Raw Material, Packing Material
Dynamic conditions and pulls at the time of
Protocol registration
Configurable Protocol Approval Process
Once a protocol is approved, changes can be
made as per the present stage of the protocol.
All such changes are tracked and maintained
in a audit trail.
Pull 1
1 month
Pull 2
2 months
Storage
Condition 1
Pull 3
3 months
Pull 1
1 month
Pull 2
3 months
Product /
Specification
Storage
Condition 2
Pull 3
6 months
Pull 1
3 months
Pull 2
6 months
Storage
Condition 3
Pull 3
12 months
Pull 4
24 months
Configurable, Stability Protocol
registration.
Other Supporting features
Stability study specific Worksheet
generation.
Copy control of the worksheets
Stability specific COA header and
footer configuration
Stability specific test trends
Automatic Sample Login as per Calendar
Stability Sample Chambers (Optional)
Define a chamber with all attributes
with Storage positions defined.
Stability chamber is assigned to
Condition
Sample storage along with Quantity
stored
Sample withdrawal with Quantity
withdrawn
Stock inventory reports
Sample Storage in the
chambers
Stability Studies reports
Reports on click of the mouse:
Sample Analytical Test report (COA) for
each sample
Very comprehensive , comparative report for
one product, different batches, Selected
condition, selected Tests.
Trend graphs
Annual calendar
Reports as per protocols
Result compilation
Stability Sample pull list for a
period
Stability Sample Calendar
LIMS Configuration
Configuration
Objects
There are in excess of 100 Objects in
CaliberLIMS 3.0 and every object
has inherent capability /
configurability to include activities
like:
Initiation, Approval and E-sign challenge
and generation of Audit Trails.
Object configuration
----You can decide how you want LIMS to be!!
Architectural details !
Application Architecture
Developed on MS ASP.net
CaliberLIMS 3.XX versions are
developed on specially designed
OOPS model to suite the regulated
industry practices. (GLP)
More than 100 objects to make the
system highly configurable.
Increased configurability of the
objects
Technical Benefits
DB (SQL/ ORACLE)
services
Status
query
services
Mail
Response
Services
SOA Layer
Messaging
Data Access Layer
Business Logic
ASP.net
User Interface Layer
IE5.5
Transaction interface
Layer
N-tier Web Architecture.
Highly scalable architecture
Orion
Instruments
Interface
MES
Software Environment
Application server: Windows 2003
Front End: User Interface: IE 5.5
Back end:
1. SQL 2000 Above
2. Oracle 9i & above
Web server: IIS 6.0
Regulatory Compliance
Regulatory/ Quality Standards
21 CFR Part 11 Code for Electronic
Signatures and Electronic Records
GLP Good Laboratory Practices
ISO 17025
NABL
GAMP compliant documentation
Electronic Signature
Deliver More… deliver excellence !!
Caliber Infosolutions, Inc.
100, Technology Dr.
Suite 400
Pittsburgh. PA 15219
[email protected]
www.caliberinfosolutions.com
Caliber Technologies Pvt. Ltd.
401,406, Bhanu Enclave, Model Colony,
Hyderabad-500038, INDIA
Tel :91 40 23811322,
[email protected] URL:
www.caliberindia.com