CHAPTER – 1

AN OVERVIEW OF THE INDUSTRY

 1.1 Brief History of the Industry

Wipro Ltd., the flagship company of the Azim H Premji group was incorporated in the year
1945. The company started off originally as a manufacturer of vegetable ghee/vanaspati,
refined edible oils etc. Gradually the company has diversified into various other businesses.

Today Wipro Limited is the first PCMM Level 5 and SEI CMM Level 5 certified IT Services
Company globally. Wipro provides comprehensive IT solutions and services, including
systems integration, Information Systems outsourcing, package implementation, software
application development and maintenance, and research and development services to
corporations globally.

In the Indian market, Wipro is a leader in providing IT solutions and services for the
corporate segment in India offering system integration, network integration, software
solutions and IT services. Wipro also has profitable presence in niche market segments of
consumer products and lighting. In the Asia Pacific and Middle East markets, Wipro
provides IT solutions and services for global corporations.

Wipro's ADSs are listed on the New York Stock Exchange, and its equity shares are listed in
India on the Stock Exchange – Mumbai, and the National Stock Exchange, among others.

Wipro is the leading strategic IT partner for companies across India, the Middle East and
Asia–Pacific – offering integrated IT solutions. They plan, deploy, sustain and maintain your
IT lifecycle through their total outsourcing, consulting services, business solutions and
professional services. Wipro InfoTech helps you drive momentum in your organisation – no
matter what domain you are in.

Backed by their strong quality processes and rich experience managing global clients
across various business verticals, they align IT strategies to your business goals. Along with
their best of breed technology partners, Wipro InfoTech also helps you with your hardware
and IT infrastructure needs.

The various accreditations that they have achieved for every service they offer reflect their
commitment towards quality assurance. Wipro InfoTech was the first global software
company to achieve Level 5 SEI–CMM, the world's first IT Company to achieve Six Sigma, as
well as the world's first company to attain Level 5 PCMM.

Their continuing success in executing projects is a result of their stringent implementation

of quality processes. Deploying quality frameworks to align with your business will give
you the benefit of a smooth and transparent transition while providing complete IT
lifecycle management. Reliability and perfection are a result of their adherence to these
quality benchmarks and this has been their key differentiator, while helping drive the
business momentum.

The company’s experience and expertise are measured against globally recognized
standards to ensure their commitment in delivering competitive solutions to their
customers. Wipro InfoTech optimises quality by maintaining high standards in service
offerings and products, as well as internal processes and people management. They believe
in constantly scaling quality standards by expanding our efficiency in all areas beyond their
basic IT offerings.

Different people perceive innovation in various ways. At Wipro InfoTech, their innovative
thinking helps them adopt newer business lines and offerings based on your business
expectations. They have adapted to the changes brought about by technology and business
and this has helped us improve customer experience through service delivery and process
optimisation.

In 2013, the company decided to shut down its hardware manufacturing business because
it offers no competitive advantage. It would no longer build Wipro–branded desktops,
laptops, and servers, including the Super Genuis line of PCs and Net Power servers. It
would now look to beef up its footprint as a systems integrator and increase its focus on IT
services. 

Different divisions of the company:

Wipro Technologies – Wipro Technologies is the global IT services business division of

Wipro Limited. With over 20 offices around the world, Wipro Technologies is the No.1
provider of integrated business, technology and process solutions on a global delivery
platform.

Wipro Infotech– Wipro Infotech is the leading strategic IT partner for companies across
India, the Middle East and Asia–Pacific – offering integrated IT solutions. We plan, deploy,
sustain and maintain your IT lifecycle through our total outsourcing, consulting services,
business solutions and professional services.

Wipro Consumer Care and Lighting– Wipro Consumer Care and Lighting, a business unit of
Wipro Limited, has a profitable presence in the branded retail market of toilet soaps, hair
care soaps, baby care products and lighting products. It is also a leader in institutional
lighting in specified segments like software, pharma and retail.

Wipro Infrastructure Engineering – Wipro Infrastructure Engineering was Wipro Limited’s

first diversification in 1975, which addressed the hydraulic equipment requirements of
mobile original equipment manufacturers in India. Over the past 25 years, the Wipro
Infrastructure Engineering business unit has become a leader in the Hydraulic Cylinders
and Truck Tipping Systems markets in India, and intends growing its business to serve the
global manufacturing requirements of Hydraulic Cylinders and Truck Tippers.

Wipro GE Medical Systems – Wipro GE Medical Systems is a joint venture between Wipro
and General Electric Company. As a part of GE Medical Systems South Asia, it caters to
customer and patient needs with a commitment to uncompromising quality. Wipro GE is
India’s largest exporter of medical systems, with unmatched distribution and service reach
in South Asia. Wipro GE pioneered the manufacture of Ultrasound and Computed
Tomography systems in India and is a supplier for all GE Medical Systems products and
services in South Asia.

Products and services offered by the company:

Wipro was having its presence across various verticals viz;(it decided to shut its hardware
business in 2013)

 Wipro Personal Computing Products  

 Enterprise Products
 Software Products and Licences

Milestones  

 2012:                                                                                                                  

           Wipro – Australia–based MMG Selects Wipro as Strategic Partner

           Wipro – Wipro Acquires L.D.Waxson with Skincare brands Bio–essence & Ginvera
           Wipro Tech joins Car Connectivity Consortium (CCC) to develop smartphone–based
connected–car solutions
           Wipro Technologies, Oracle joined hands to offer next gen Oracle Fusion HCM
solution 

           Wipro Infotech, the India and Middle East, IT Business unit of Wipro launched the
e.go aero range of ultraportable notebooks

           Wipro Wins NASSCOM Corporate Award for Excellence in Diversity and Inclusion
2012

 2011: Inaugurated its first rural BPO at Manjakkudi village in Tamil Nadu to
capitalize on literate talent pool available in the region.
 2011: Wipro has signed an agreement to acquire majority stake of Brazil based
hydraulic cylinder manufacturer R.K.M. EQUIPAMENTOS HIDRAULICOS.
 2010: Wipro Infotech –– the India, Middle East and Africa, IT Business of Wipro––
has been awarded a 5–year IT outsourcing contract by Vasan Eye Care – one of
India's largest network of eye care centers and a unit of Vasan Healthcare Group.
 2010: Wipro Technologies, the global IT services business division of Wipro, has
jointly with Citrix Systems entered into an agreement with Microsoft.
 2008: Launch of Wipro Egypt Development Center
 2008: Launch of Wipro GSMC in Kuala Laumpur
 2007: Wipro Arabia Joint Venture found
 2006: Acquisition of 3D networks
 2006: Launch of GSMC– Global Service Management Centre for remote service
delivery
 2004: Start of Total Outsourcing business
 2002: Start of Consulting business unit
 2001: Launch of Wipro Infotech Middle East & Asia–Pacific operations
 1998: Mission Quality journey started with focus on Six Sigma
 2000: Wipro Listed on NYSE
 1998: Re–launch of Wipro branded PC
 1995: Wipro–BT joint venture started
 1995: Joint Venture with Acer started
 1995: Partnership with Cisco announced
 1995: Off shoring services started
 1992: Launch of global R&D services
 1990: Launch of global software services business
 1988: Partnership with Sun Microsystems announced
 1986: Manufacturing tie–up with Epson for printers
 1986: Start of Wipro PC manufacturing (with India's first surface mounted
technology)
 1984: Start of Wipro Systems – focus on software products (Wipro branded as well
as distribution business)
 1981: Manufacture of mini computers started at the Mysore factory
 1980: Birth of IT business under banner of Wipro Information Technology Ltd.
focused on hardware manufacturing and R&D
 1945: Manufacturing of edible oils
 1.2 Business Process of the Industry

A consolidated strategy is required to improve manufacturing process efficiency by

harmonizing processes for electronic batch records (EBR) and electronic device history
records (eDHR) for pharmaceutical and medical devices plants. This can help improve real-
time visibility, data integrity and enhance data quality besides ensuring compliance and
traceability. This article provides an overview on a case study for electronic batch records
and electronic device history records process harmonization strategy.

The life sciences and medical devices industries are currently facing many challenges in a
competitive global market. To maintain market position and meet customer demands, the
organizations are under pressure to introduce new products early to the market with
optimized costs. There is another challenge to conform to evolving local and global
regulatory guidelines for ensuring manufacturing quality and minimizing product recall,
which can be achieved by keeping track of batch records (BR) and device history records
(DHR). Regulatory agencies emphasize keeping track of production details for each product
manufactured by organizations, which is a cumbersome process, as management of BR and
DHR is largely paper based, people dependent process in many organizations.

The manual processes take a lot of time and efforts and are often error prone, impacting
overall costs and operations. Incorrect entries, unclear documents, rounding and
calculation errors can significantly affect approval processes. Industry is exploring an
efficient process to generate electronic, digitized batch record and device history records.

BUDINESS NEEDS

Data level

Improving manufacturing processes by replacing paper based mechanism with electronic

data capture is utmost important.

Typical outcome at data level is:

1. Reduction of paper and human errors

o An operator will work more effectively with all the process data to-be
captured electronically, as he/she is experiencing time-consuming, error-
prone data re-entry, resulting from multiple, disparate, and paper-based
systems. Moreover, the operator will look for ways to minimize or eliminate
human errors.
2. Assurance of Manufacturing Compliance
 Quality management teams need to have a quick and efficient way to trace
o
and review records for timely release of products. EBR/eDHR enforces the
consistent execution of manufacturing steps while providing an accurate,
real-time view of processes and deviation data. Apart from saving time
associated with enforcing procedural compliance, an electronic system
would streamline detecting, tracing, monitoring, closing, and documenting
deviations in the manufacturing processes.
3. Improvement in Data Integrity and Process Verification
o Plant manager needs to focus on overseeing daily operations of the plant and
ensuring consistent production of high quality products. Plant manager role
also entails improving productivity to reduce costs. Data captured in an
electronic system will have the highest level of data integrity and enable
automated review, shortening the cycle time for product release and
preparation of batch records. Furthermore, electronic data would enable the
formulation of strategies for improving product quality and process
efficiency.

Plant level

Due to the unique nature of production processes across various manufacturing plants,
data capture processes and compliance needs are inherently complex. Examples of these
complexities include:

1. Different system requirements across various plants owing to legacy systems

inherited from individual subsidiaries post mergers and acquisitions, with little
corporate standardization.
2. Process similarities across different products and process variations between
similar products
3. Historical process consistencies such as downtime trends, past deviations
4. Manual processes cause difficulties in traceability
5. Most of the data capture is either paper-based or manually entered into the
electronic system.

Need Of The Hour – Best Practices

EBR/eDHR implementation for batch records and device history records automation has
become paramount and this can serve as a springboard for connecting the stakeholders for
governance, data capture, and quality as well as providing a platform for manufacturing
process improvement.
It is recommended that process mapping should be performed to identify and eliminate
waste before the EBR implementation.

Industries are adopting some of the best practices to move towards digitization and
automation of EBR and eDHR, which are discussed below.

1. Integration of EBR across systems such as manufacturing execution systems (MES),

laboratory information management systems (LIMS), process control systems (PCS),
quality management systems (QMS), ERP system and any solutions where data is
recorded during batch manufacturing.
2. Deploy EBR as process engine to guide tasks and instructions for operations, also as
a data hub for automated, real time data capturing for testing procedures,
environmental monitoring, quality parameters, product life cycles and
manufacturing automation data
3. Deployment of track-and-trace capability for eDHR regulatory. (Regulatory
requirements for electronic batch records extend beyond manufacturing plant to
the supply chain. The challenges create a need for more sophisticated and robust
eBR capability)
4. Integration with quality management systems (QMSs) for corrective and preventive
action (CAPA) and non-conformance workflows are required to be inextricably
linked to the production process, in conformance with industry specific regulations
5. Weigh and dispense — build and implement capability for support of weigh and
dispense, even before moving to electronic batch records
6. Enterprise-level reporting for serialized events, digital signatures, transaction
datasets, mandated data standards and links to central regulatory and government
repositories
7. Data management solutions for governance, randomization, storage and encryption
8. Dedicated workstations and functionality for serial number management,
configuration and electronic packaging aggregation
9. Synchronization and harmonization across established ERP, automation and
operational systems such as MES, transportation management systems (TMSs) and
warehouse management systems (WMSs) with an extending visibility at edge
processing transactions for managed efficiency of serialized transactional events.
10. Operational-line-level configuration for material flow, automation, scanning, routing
and data capture through vision, inspections systems and high-speed camera
technology
11. Interactive dashboards for serialization line and network planning
12. Manufacturing execution — process monitoring, in-process quality, the ability to
dispatch, manage and control work based on global instructions from ERP, and
supply chain planning/ execution suites
 13. Warehouse management — raw material, work in process, finished goods, directed
put-away and picking for make to order and ship from stock, remote warehouse
support, vehicle pool management, and automated dock assignment
14. Equipment for scanning and data capture — integrated, fixed mount and handheld
mobile devices
15. Data capture, physical interfaces such as RFID chips, pre-coded labels, packaging
and substrates
16. Integrated inspection machines, line control and management systems often
configured or customized (E.g., bottles, vials and secondary packages, serialized
event capture reconciliation and reporting)
17. Specialized check weighing machines and packaging automation machines

Elements of Electronic Batch Records

Key enablers of EBR/eDHR for each benefit area and specific examples of improvements
that will be realized when manufacturing execution and data capture moves from
manual/paper based to automated/electronic are depicted in figure 1.

 Electronic Work Instructions / Data Entry à Reduction / Elimination of Paper

Records
 Interface Source Data with SAP à Improvements in Data Integrity and Process
Verification
 Interface Support Systems with Execution & SAP à Assurance of Manufacturing
Compliance 
The technology layer in the figure 1 provides general descriptions of the types of
applications cutting across multiple benefits “pillars” to enable EBR creation.

These descriptions are generic as there could be multiple technical pathways to achieve the
endpoint. For instance, the requirements for a digitization solution can be met by
applications with custom PI sheets in SAP or electronic work instructions and data capture.

Key Business Benefits

Manufacturing process harmonization and digitization benefits business with:

1. Digitization by reducing the use of paper-based data capture and eliminating human
errors
2. Right First Time (RFT) time savings by reducing records review time of QA and
supervisor
3. Enhanced data integrity, data quality, compliance traceability and conformance
4. Real-time, electronic data capture and review of process data
5. Improve batch release cycle time and reduction in production timelines
6. Automatic calculations for reconciliation and electronic management of audit trail
7. Increased compliance by reduction in deviations, non-conformances and associated
investigations

Digitization of EBR and eDHR coupled with manufacturing process standardization can
help improve compliance, data quality and data integrity, and enhance operational
excellence and global collaboration.

1.3 Market Demand And Supply – Contribution to GDP – Revenue Generation

In today’s era of high customer expectations, businesses naturally aspire to the highest
levels of service, from order confirmation to guaranteed delivery dates.  At the same time,
it’s imperative that they develop the ability to secure business continuity—to anticipate
and mitigate possible supply chain disruptions, both local and global, that can range from
political to environmental to economic and can seriously disrupt operations without
warning. 

Yes, most companies have invested in sophisticated enterprise resource planning (ERP)
systems within the confines of their own organization; and many have gone further,
expanding to include point-to-point connections with external partners. But if businesses
are to succeed in both quality customer service and business continuity, they must take a
new approach to supply chain management—specifically, the ability to orchestrate
suppliers, assemblers, and distributors to a level of accuracy unheard of just a few years
ago. Achieving that requires a shift to a singular view of goods and services among all
entities that touch the supply chain. 

From Insularity to Integration

Only a few years ago, companies were busily drawing up policies around how to close off
and protect their supply chains. Now, to beat the competition it’s all about collaboration.
Indeed, in a recent supply chain trend analysis, Gartner took it a step further, focusing on
the concept of “co-opetition”—the idea that partnering with potential competitors can be a
transformational differentiator.

Yet, many companies are still using specific and limited point-to-point connections.
Certainly that insular approach had value in its day. You could protect the integrity of your
company’s system while selectively sharing information with your supply partners as
needed. But taking this approach today makes little sense. Each dedicated connection point
requires its own contractual framework, information exchange protocol, systems, and data
security arrangements—essentially a new wheel must be reinvented every time another
connection needs to be made. It’s a high maintenance model with limited flexibility,
especially in the current business environment.

At the highest level of collaborative maturity we see organizations taking full advantage of
today’s communications and analytics technologies by fully integrating suppliers and
customers into the core supply chain through a common architecture, such as a portal via
Cloud technologies or rolling out a standard interface to suppliers and customers. 

This full integration and collaboration allows all parties to enjoy seamless end-to-end
visibility of relevant supply chain processes and movements, and facilitates the collection
of data that can be used for after-event reporting and management, forward-looking
predictive analytics, and, of course, smarter supply chain decision-making. 

It appears to be an obvious solution, so why aren’t more businesses adopting it? Although
the technologies are there, most organizations have to radically re-think their policies and
business processes. But, consider how a collaborative approach could enhance your
success if your plan is to expand your business into new markets, whether geographical or
product-related. In either case, expansion requires significant upfront investments and a
strong network of local support which could take years to establish. Now imagine you
could “set up shop” through integration and collaboration with suppliers and customers,
and have the ability to instantly add or remove capabilities based on an agreed global
standard. The potential pitfalls of expansion begin to diminish.
Preparing for an Integrated, Collaborative Supply Chain 

One of your initial steps in laying the foundation for a more integrated, collaborative supply
chain should be engaging with suppliers and customers to make sure everyone is ready and
eager to participate. 

With buy-in from all parties, begin to modularize each component of the supply chain. A
good starting point would be something as basic as agreed-upon definitions. “Open
purchase order” can mean different things to different suppliers, for example. Same with
“late delivery,” “damaged goods,” or “stock  replenishment.” Speaking the same language as
your partners is a first step toward standardizing and integrating.

Building on this, you’ll want to consider rules that lay the foundation of the overall
orchestration. So, for example, a rule could determine that if stock is not available at one
supplier there’s a hierarchy that would automatically route the request to the next
available supplier—even if it’s more costly—and charge the difference back to the first
supplier. 

On the customer side, start by thinking about your readiness for modern e-commerce best
practices. Is your organization ready to commit to a delivery date, regardless of product,
geographical distance, component requirements, and order size? If not, what would it take
to move you toward this vision? Where does your value chain have its weakest links and
what can be done to strengthen them?

Putting Technology to Work in Transforming Your Supply Chain

One of the goals in establishing this new collaborative, integrated supply chain is efficiency
in the face of hyper agility and uncertainty. We’re living in a volatile business environment.
Assuming you are aggressively addressing the management side of supply chain, there are
three disruptive technologies that can assist you in establishing an efficient, seamless
collaborative supply chain.

The first is Cloud computing. Over the past five years, Cloud has matured significantly, and
increasing numbers of businesses are taking advantage of the “utility” aspects of using and
paying for IT infrastructure services as and when required—without traditional upfront
investments and multi-year deployment timeframes. So, the user would pay the Cloud
solution service provider by transaction or by connection. With Cloud middleware,
collaborating with other parties becomes truly plug and play.

Advanced analytics—or “big data analytics”—used to interpret large swathes of structured

and unstructured data is accelerating to the point where rule-based decision-making is
replacing what was previously a long-term process of data extraction, compiling reports,
and implementing decisions. Affordable “in-memory” computing and faster network
connections make it possible to interpret and respond to events with tremendous speed
and efficiency.

Finally, we have mobility. Information and analytics can now be accessed anywhere at any
time—by a sales rep in the field, for example—enabling quick decision-making with better
information. So, if you are traveling and receive information on your tablet about a
significant increase in demand and you don’t know where to supply it from, you can run a
scenario across your network to determine where to source it, and then write that scenario
back into your supply network planning and production systems.

As an example, consider the Cloud-enabled supply chain architecture shown below:

Suppose one of the customers is experiencing volume reductions due to the economic situation in
a particular market. As the demand signals reduce and customer stock increases, the core
enterprise is able to react instantly by reducing production, re-assigning manufacturing capacity
to alternative products, or alerting its suppliers of the expected demand reduction. Similarly
when demand picks up again, the customer side pull will be immediately visible through
customer stock reductions and increased order frequency. 

While the majority of the day-to-day decisions would be hard-coded within the rules of the
system, human interaction is also important if, for example, certain thresholds are exceeded. In
the event of an unexpected factory shut-down or major environmental event, a user alert would
be created through, say, a mobile device to which key people involved in the supply chain can
respond

. The business benefits of this model span the entire supply chain. As demand is constantly
anticipated and fulfillment is monitored, inventory levels are reduced, from components and 
 

raw materials through finished unsold products and into sold products in customer
warehouses. Service levels are increased, and resilience is strengthened without the need
to create excessive buffering of products. Supply chain operating costs are reduced, and
assets are better utilized as a result of the increased speed of decision-making and capacity
prioritization

Collaboration-Enabled Orchestration

Technology has made our world an incredibly interconnected “system of systems” and
enabled a new age of multi-modal boundless collaboration that opens up almost endless
possibilities across the entire supply chain. 

In the future, we will see more and more supply chains operating with a minimum of
human direction. Similar to information networks such as the Internet, they’ll be able to
automatically reconfigure themselves. Forward-looking enterprises that take advantage of
this will dominate tomorrow’s market place.  

In order to differentiate and reach previously impossible levels of efficiency and speed,
supply chain strategists need to radically re-think their businesses and decide which
markets, operating models, and value creation approaches they want to embrace in order
to stay competitive. 
1.4 Level and Type of Competition – Firms Operating in the Industry