IIHMR Oasis Group of Companies New 1

63
Role of information technology in pharmaceutical industry 

Transcript of IIHMR Oasis Group of Companies New 1

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Role of informationtechnology inpharmaceutical

industry 

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The Oasis group

Oasis one of the leadingnames in Indian

pharmaceutical sector

Serving the industry

for over 3 decades

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Valued clientele

Johnson and JohnsonFulford-Schering, Wyeth

Micro, gsk, Neon

Elder, IPCA, IngaRusan, Bayer, Mankind

RDPL (Jaipur), Indoco

Cosmos (Nairobi)

LaGray (Ghana)

Astron Research (U.K.)

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The Oasis group

Software development and its services

Oasis Infotech, Jaipur

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Oasis Test House Limited

Reputed commercial testing laboratory

approved by the Drugs Controller,

Rajasthan

Serving over 500 clients across India

as their preferred partner for quality

Analytical & research services

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Oasis Test House Limited

Providing GLP compliant testing services

to the pharmaceutical industry,

government and academia

Group unit at Ahmedabad,

Oasis Test House

Analytical & research services

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Oasis Test House Limited

Testing services against the laid down

standards / specifications (including

BIS, IP, BP, USP, JP, EP etc.) for variousmaterials, like:

Pharmaceutical formulations

Tablets, Capsules, Liquid oralsInjectables, Ointments etc.

and API/Bulk drugs

Analytical & research services

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Software development services 

Oasis Infotech, Jaipur

Serving the pharma industry for over

21 years with its innovative

high end software solutions

Successful in undertaking varied

assignments of software development,

implementation and consulting services

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Software development services 

Oasis Infotech, Jaipur

Offers industry specific solutions with

Domain and technology expertise

Over 100 installations, nation wide

and also overseas implementations

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Software development services 

In India,Oasis has given

a new dimension

in implementation of 

software solutions in

pharma industry

keeping in view

the Indian regulationsas well as the practices

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 The birth of an innovative software

LabmasteR 

Laboratory Information

Management System

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Typical manual working in the lab … 

details of sample received for testing

entered in sample register, manually

preparation of under test labels, hand

written, repeated parameters

on sample issuance, analysts used to refer

pharmacopoeia etc. to see specifications /testing procedures, lengthy and time

consuming step

Way back in 1988

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Typical manual working in the lab … 

analysis carried out as per the

specifications, note books

maintained to record readings /observations;

chances of test omission

calculations were

done manually,

chances of error

Manual procedure

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Typical manual working in the lab … 

results were manually compared with

standard limits,

possibilities of mistakes

decision about sample passing / failing:

taken by analysts

individual report checking by senioranalyst for its correctness and

completeness

Manual procedure

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Typical manual working in the lab…

 

CoA (certificate of analysis) written /

typed using a typewriter or an editing

software: laborious job

CoA re-checking by senior analyst before

signing up, approval/rejection labels,

hand written

recording of final result, in sample register

Manual procedure

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Consider the time, effort and complexityinvolved e.g., if lab had about 100 samples

to be processed every day

The question was

how to

… handle sample volumes

… avoid errors and repeated calculation

mistakes

Manual procedure: limitations

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how to

… avoid referring specifications / test

procedure and comparing results,

manually

… organize and maintain

documentation up-to-date to face

effortless FDA inspections /auditing

OasisLIMS

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The answer was one:

Automation of the activities

Oasis employed a team of subject

experts and programmers to develop

a software program in-house in 1987

How Oasis dealt with the situation?

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after many months of efforts, the

software was ready for

basic operations

Finally, it went LIVE successfullyin the Lab

How Oasis dealt with the situation?

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Within few months of its operations,it was found thatthe output from existing manpowerimproved dramatically

by over 40%resulting in increasein productivity and efficiency

… quality in service to the customers wasalso improved

Improvement in productivity

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Oasis visualized its great potential,future prospects and commercial viability

Floated this idea in the benefit

of the industry:it was a new idea of its kind in India

Finally,

the whole concept was given a shape of a

software solution

Spotted the opportunity

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1988

Launched elementary LIMS at IPC Calcutta

Oasis was the fist company to introduce

LIMS concept in India

Initially, it was concept selling

Dabur, Merind, Johnson & Johnson were

amongst few implementations

OasisLIMS: the journey

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OasisLIMS: the journey

Milestone 1: 1994

Upgradation for network environments

Multiple user support

common database access

Computer user community was

growing slowly

Still difficult to sell such a software

in India their was slow adoption

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OasisLIMS: the journey

Milestone 2: 2000

Windows as preferred operating system,

Graphical User Interface (GUI) mania was

spreading all overPharma industry was taking a

new shape, LIMS started picking up,

but gradually

Now, LabmasteR became a stronger

software, functionally & technically

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OasisLIMS: the journey

Milestone 3: 2004

US FDA 21 CFR Part 11 compliance, to

address security and authenticity issues

Introduced Enterprise LIMS

in multi location environment, WAN

New add-on modules and

improvements to enhance utility of the software

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Milestone 4: 2007

Advent of Internet technology changed

the way people work

Seamless reach with24x7 data accessibility, anytime, anywhere

New launch, Web based Enterprise edition

Improvements in user friendliness

OasisLIMS: the journey

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Milestone 5: 2009Intel software partner,Intel software partner programfor collaborative development

Working with SAP Labs onLIMS SAP R/3 integrationfor acquiring PBNW(Powered by Net Weaver)

To offer integratedquality management systemsacross the globe

OasisLIMS: the journey

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2006: Another endeavorFocus: Small and medium Enterprises

Parallel success with LIMS, oasis

developed new software for pharma

industry in the year 2006

With Govt. of India calling for

mandatory GMP compliance since 2005,

pharma industry was finding it difficultto adhere to Schedule M norms without

a software system in place.

CrisCon for SMEs

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Another endeavor

There was always a need for domain

specific software solution for

the pharma industry

Oasis developed and implemented

CrisCon at its group unit

Cris Pharma India Limited

Dehradun

CrisCon for SMEs

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Another endeavor

After one year of successful run,

Oasis implemented CrisCon

at 10 clients,to make it more matured

through standardization to make

it widely acceptable software

in the market

CrisCon for SMEs

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The Oasis group

Contract analytical and research services

Oas is Test Hous e Ltd, Jai purOasis Test House, Ahmedabad

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Effective MIS toolsusing pharma specificsoftware solutions..

OasisLIMS

CrisCon

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OasisLIMS

Sample login /Registration

Work sheets /Protocol sheetsCalculation of Test Methods

Certificate of Analysis

Specification Maintenance

MIS: OasisLIMS

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Some MIS reports

Sample register (category wise)

Labels (under test, approved, rejected, etc.)

Lab performance report

Samples pending for sampling

Sample approval status

RMs due for retest

MIS: OasisLIMS

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Some MIS reports

Trend Analysis

Stability studiesVendor rating

Equipments calibration

management

MIS: OasisLIMS

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Some MIS reports

Control / reserve samplesmanagement

Reagents, standard solutionsmaintenance

Reference and working standardsmanagement

MIS: OasisLIMS

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Saves valuable man-hoursof technical staff 

Saves time spent on calculations

and in writing and checking reports

The time saved – utilized for otherimportant / productive tasks

Reduces operational costs

Documents & data –better organized

MIS tool: Benefits

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OasisLIMS coversabout 70%of the activities /requirements laid down in GLP

About 30% requirementsare relating topremises,infrastructure,manual working etc.

GLP vs. LIMS

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The Oasis group 

Pharma Production and

Contract Manufacturing Services

Jaipur Pharmaceutical Works, Jaipur

Cris Pharma (India) Ltd, Dehradun

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360° visibilityOffers 360° visibilityacross enterprisefor strategic decision making

Business visibility

Purchase of critical items

Sales to major clientsStatus of high value orders

Status of important sales orders

MIS: CrisCon

360°visibility

MIS C i C

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360° visibility

Cash flow statements onday-to-day basis

P&L statements, when required

MIS: CrisCon

360°

visibility

i

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Operations visibility

What is happening across theplants?: overall status

What is happening at distribution

points in supply chain

Production batch status, output

MIS: CrisCon

360°

visibility

MIS C i C

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Cost controlling

Product costing

Batch by batch tracking andprofitability

Variable cost analysis on various

parameters

MIS: CrisCon

MIS C i C

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Material Resource Planning

Production planning in consonancewith sales

Avoidance of unnecessary capitalin material’s inventory

Avoidance of storage problems dueto excess inventory

MIS: CrisCon

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MIS C i C

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Documentation management

Audit ready for approvingauthorities

Trouble shooting

Better trouble shooting

Better tracking and identificationof problem area

MIS: CrisCon

O i ft A

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Oasis software: Awareness

User Community … 

Direct exposure to the product:by over 20000 technocrats

Over 100 implementation sites.

O i ft A

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Oasis software: Awareness

User Community … 

More than 2000 end userslog-on to work on

oasis software solutionseverydayto meet the diverse challenges of the world’s highly competitive

industry: pharmaceutical and lifesciences

S ft d O i fl hi

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Software under Oasis flagship

OasisLIMSLaboratory Information ManagementSystem

CrisCon

Pharma Enterprise solution

Enterprise Resource Planning forsmall and medium enterprises(SMEs)

S ft d O i fl hi

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OasisCMS

Change Management Systemfor enterprises

CrisSmart 

SFA/CRM

Sales Force Automation System

Software under Oasis flagship

The Oasis g o p

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The Oasis group 

Education & Training Services

B r i d g i n g a g a p o v e r A c a d e m i a & I n d u s t r y

Oasis Edutech, Jaipur

P fil

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Profile 

To bridge the gap between industry andacademia, Mr. Vinod Kalani has recently

established the education and training

division, Oasis Edutech, to provide themuch needed technical manpower trained

on pharma specific solutions, for

computerization of pharma industry and

even SMEs.

B idging o e Academia & Ind st

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Bridging over Academia & Industry 

Mission

 To contribute significantly, in bridging the

pharmaceutical industry-academia fordeveloping and matching the skills of passing out

students with current industrial practices

To provide the much-needed technical

manpower trained on pharma specific

solutions, for automation of pharma industry /

trade, R & D labs, CROs, Analytical Labs

Oasis Edutech programmes

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Oasis Edutech programmes 

• To get well versed with the current

industry practices and understandingMIS tools

• To obtain practical knowledge in GMP,GLP, QA, QC activities at a manufacturingunits, Testing Lab and Software

development division by the industryexperts, bridging the gapbetween theory and the reality

Oasis Edutech programmes

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Oasis Edutech programmes 

• Preparation for the latest trends andterminology used in Industry

•To become a key role player in rolling outcomputerization projects in theorganization

To have an edge over other studentshaving similar qualifications

Oasis Edutech programmes

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Oasis Edutech programmes 

• To cater the industry more competently

• To get a specialist status in the industry

• To have better career prospects in theindustry by getting considered for thebetter placements and faster promotions 

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Profile

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Profile 

Besides being efficient in managementMr. Kalani has been an active member of 

various associations such as

Indian Pharmaceutical Association,Indian Pharmaceutical Graduates Association

His efficiency and credibility is acknowledged

equally by the professionals, the industry andthe Government.

Profile

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Profile 

President, Rajasthan Pharmaceutical

Manufacturers Association

Vice Chairman, Confederation of Indian PharmaIndustry (CIPI)

Gen Sec, Federation of Pharma Entrepreneurs

(FOPE)

Senior Gen. Secretary, Trade & Industry Cell,

Rajasthan Pradesh Congress Committee

Associations

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 President, RPMA

R ajasthanPharmaceuticalMfg. Association

Vice Chairman, CIPI (North)

Confederation of IndianPharmaceutical Industry

Associations

Member, Central Executive Committee, IPA

Indian Pharmaceutical Association

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Award function - 2008

Receiving the IPA Fellowship Award

FOPE Summit Dehradun 2009

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FOPE Summit, Dehradun, 2009

Receiving the award for

outstanding performance

from Dr Rajiv Bindal,

Health Minister, H.P.

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