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TCS Assurance and Compliance Solution (TAnCS) Flyer_A4_091012

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<strong>TCS</strong> <strong>Assurance</strong> <strong>and</strong><br />

<strong>Compliance</strong> <strong>Solution</strong> (<strong>TAnCS</strong>)<br />

Life Sciences<br />

The life sciences industry is required to be compliant with multiple regulatory requirements. Pharmaceutical<br />

companies are required to focus on proper implementation of quality systems, <strong>and</strong> regulatory compliance<br />

requirements to ensure business continuity <strong>and</strong> achieve optimal quality. Conforming to multiple regulatory<br />

st<strong>and</strong>ards in such a scenario can be a challenge. Organizations can benefit using an independent view leading to<br />

unbiased quality assurance, improvement in product <strong>and</strong> process quality <strong>and</strong> reduction of cost overheads,<br />

testing efforts, <strong>and</strong> IT compliance gaps.<br />

Tata Consultancy Services (<strong>TCS</strong>) brings to you the <strong>TCS</strong> <strong>Assurance</strong> <strong>and</strong> <strong>Compliance</strong> <strong>Solution</strong> (<strong>TAnCS</strong>) offering to<br />

help address these needs. The solution creates a seamless synergy between the various assurance activities such<br />

as testing, validation <strong>and</strong> quality assurance for the system life cycle, <strong>and</strong> relies on a holistic approach to deliver<br />

quality. <strong>TAnCS</strong> not only improves the cost of quality <strong>and</strong> audit readiness, but also ensures optimized costs <strong>and</strong><br />

efficiencies, <strong>and</strong> hassle-free IT compliance governance.<br />

Overview<br />

Our commitment to quality <strong>and</strong> quality models with a focused<br />

approach to Life Sciences industry <strong>and</strong> its business processes has<br />

helped us underst<strong>and</strong> your challenges better. Our comprehensive<br />

solution delivers across the quality life cycle from process definition<br />

to deployment <strong>and</strong> assessment. What's more, <strong>TAnCS</strong> ensures that<br />

the systems are audit-ready by means of periodic reviews, audits,<br />

deviation management, etc.<br />

<strong>TCS</strong> <strong>Assurance</strong> <strong>and</strong> <strong>Compliance</strong> <strong>Solution</strong> strives to integrate testing,<br />

validation <strong>and</strong> quality assurance together for delivering Quality as a<br />

whole, thereby ensuring business continuity. This integrated<br />

solution offers to bring the synergy in process definition, adoption<br />

<strong>and</strong> execution enabling better efficiency <strong>and</strong> effectiveness leading<br />

to holistic assurance.<br />

<strong>TAnCS</strong> brings the power of <strong>TCS</strong> 3-D validation methodology to<br />

integrate with the Software Development Life Cycle (SDLC) phases.<br />

TM<br />

3-D effectively defines the approach <strong>and</strong> implements the<br />

processes to provide a high degree of assurance across processes,<br />

people, <strong>and</strong> systems. This enables us to address any compliance or<br />

validation engagement in a successful manner irrespective of the<br />

size <strong>and</strong> the nature of technology.<br />

Benefits<br />

Besides increased <strong>and</strong> consistent quality of the product <strong>and</strong> process<br />

deployment, <strong>TAnCS</strong> increases productivity through knowledge<br />

banks <strong>and</strong> reusable assets. Similarly, <strong>TAnCS</strong> brings the following<br />

benefits:<br />

Integrated<br />

<strong>and</strong> cost-efficient assurance <strong>and</strong> compliance solution<br />

for continuous process improvement<br />

Improved<br />

IT compliance Governance<br />

Total<br />

ownership of quality & compliance services<br />

Reduced<br />

cost of quality owing to an integrated model of<br />

delivering quality services<br />

A<br />

risk-based approach throughout the SDLC.<br />

The <strong>TCS</strong> Advantage<br />

We cater to the testing, validation <strong>and</strong> quality assurance<br />

requirements of a large number of global life sciences companies.<br />

We have the capabilities <strong>and</strong> the framework to deliver to your needs.<br />

Our key differentiators include -<br />

The<br />

iQMS process framework, which has been tailored for life<br />

sciences industry. This helps meet the CSV requirement of IT<br />

Systems in the regulated environment covering different value<br />

chains.


www.tcs.com<br />

Meeting the <strong>Compliance</strong> &<br />

Validation Requirements<br />

Validation Services include<br />

Risk<br />

Assessment<br />

Validation<br />

Consultancy<br />

Validation<br />

Project<br />

Management<br />

<strong>Compliance</strong><br />

Program<br />

Implementation for:<br />

*Risk * Privacy *ER:ES<br />

Document<br />

Management<br />

Periodic<br />

Reviews<br />

System<br />

Retirement<br />

Continuous<br />

<strong>Compliance</strong><br />

Management<br />

A<br />

domain-proficient talent pool that includes a dedicated<br />

assurance workforce, as well as regulatory IT compliance CoE<br />

experts across areas like pharmaceutical/biotech/medical devices<br />

regulations across various geographies<br />

An<br />

integrated solution that brings in the best of independent<br />

verification services wrapped in our trademark <strong>Compliance</strong> Office<br />

TM <strong>Solution</strong>, ensuring quick delivery of end-to-end quality &<br />

compliance<br />

Assets<br />

<strong>and</strong> accelerators such as:<br />

Inspections<br />

Reviews<br />

CAPA<br />

Tracking<br />

Validation<br />

<strong>TCS</strong><br />

<strong>Compliance</strong> Office <strong>Solution</strong> is a centralized <strong>Compliance</strong><br />

Services framework that is used for the execution of the<br />

compliance services<br />

Reusable<br />

CSV templates/checklists, <strong>and</strong> <strong>Compliance</strong><br />

Assessment framework<br />

Requirement/design<br />

inspection methods <strong>and</strong> structural quality<br />

measurement tools for early defect detection<br />

SmartTest<br />

Manager, a test process management tool<br />

customized with electronic signatures for life sciences<br />

TM<br />

TIARA<br />

, A comprehensive assessment framework to assess<br />

assurance process maturity<br />

Test<br />

automation tools for accelerated test cycles <strong>and</strong> faster<br />

time to market <strong>and</strong> Performance testing tools for production<br />

stability <strong>and</strong> scalability.<br />

<strong>TAnCS</strong><br />

Quality <strong>Assurance</strong><br />

An overview of our offering<br />

Contact<br />

To know more about <strong>TAnCS</strong>, contact lshcip.pmo@tcs.com<br />

About Tata Consultancy Services Ltd (<strong>TCS</strong>)<br />

Tata Consultancy Services is an IT services, consulting <strong>and</strong> business<br />

solutions organization that delivers real results to global business,<br />

ensuring a level of certainty no other firm can match.<br />

<strong>TCS</strong> offers a consulting-led, integrated portfolio of IT <strong>and</strong> IT-enabled<br />

infrastructure, engineering <strong>and</strong> assurance services. This is delivered<br />

TM<br />

through its unique Global Network Delivery Model , recognized as<br />

the benchmark of excellence in software development. A part of the<br />

Tata Group, India’s largest industrial conglomerate, <strong>TCS</strong> has a global<br />

footprint <strong>and</strong> is listed on the National Stock Exchange <strong>and</strong> Bombay<br />

Stock Exchange in India.<br />

For more information, visit us at www.tcs.com<br />

IT Services<br />

Business <strong>Solution</strong>s<br />

Outsourcing<br />

Providing Unbiased &<br />

Independent View of Testing<br />

Testing Services include<br />

Test<br />

Process Consulting<br />

Test<br />

Strategy Consulting<br />

Test<br />

Planning & Test Design<br />

Functional<br />

Testing<br />

Beyond<br />

Functional Testing<br />

Specialized<br />

Testing<br />

Test<br />

Automation<br />

Test<br />

Management & Closure<br />

All content / information present here is the exclusive property of Tata Consultancy Services Limited (<strong>TCS</strong>). The content / information contained here is correct at the time of publishing. No material from here may be copied,<br />

modified, reproduced, republished, uploaded, transmitted, posted or distributed in any form without prior written permission from <strong>TCS</strong>. Unauthorized use of the content / information appearing here may violate copyright,<br />

trademark <strong>and</strong> other applicable laws, <strong>and</strong> could result in criminal or civil penalties. Copyright © 2012 Tata Consultancy Services Limited<br />

Testing<br />

Providing wholesome <strong>Assurance</strong><br />

Audits<br />

Deviation<br />

Management<br />

Policies<br />

& SOP Management<br />

Quality And <strong>Compliance</strong> aspects under one roof for Better Efficiency <strong>and</strong> Effectiveness<br />

<strong>TCS</strong> Design Services I P I 10 I 12

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