lims build

8/18/2019 Lims Build

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W H I T E P A

P E R

“Build v/s Buy”Laboratory Information Management System



T a b l e

o f C o n t e n t s

1.

2.

3. 4

4.

Introduction 3

A LIMS Primer 3

What is a COTS Solution?

Can a Pharmaceutical LIMS Really Be a COTS? 4

5. 100% is not possible 4

6. 5 Key Points for LIMS Assessment 5

7. Deciding on the Best Software System 5

8. Conclusions 6



1. Introduction

It wasn't until recently that pharmaceutical companies had

any option other than building their own infrastructure.

However, as companies moved along, internally developed

IT solutions no longer met requirements, and the company

fell into the information chasm. Management had two

simple choices: either continue to invest heavily in

internally-developed solutions, which dilutes the effort

required to focus on core competencies; or locate a

software supplier who has a solution with the flexibility and

adaptability needed to meet the changing business and

technical requirements.

This "build versus buy" scenario is an integral part of a

business life cycle. Scientific Information Production

bottlenecks occur when companies are unable to provide

their customers - both internal and external - with "product"

and service in a timely, cost effective manner. Now, two

years later, the world of pharmaceuticals has exploded into

a thriving, global business segment. Over this period of

time informatics software has matured to meet this market's

unique and continuously changing needs.

Today's informatics software must exceed the flexibility ofin-house development. The software also must provide a

scalable architecture that will not be outgrown. The

replacement solution must be configurable and adaptable

to the changing needs of the science and the business.

Once an application is shown to provide a superior level of

configurability and responsiveness to the changes in the

internal science practices, then customers should entertain

a purchased software solution. One final point about

outsourcing informatics software; time is of the essence.

Due to the rapid change in the science and the business,

implementations must be operational in less than 120 days.

Pharmaceutical Companies are spending huge time &

effort in developing home grown solutions to meet these

requirements. But the new buzzword in the pharmaceutical

industry is commercial-off-the-shelf (COTS) products and it

is being used frequently in reference to laboratory software.

COTS software is a hot topic because many companies are

hoping to significantly reduce the risk of laboratory

information management system (LIMS) implementations,

and subsequent validation processes. Companies are also

looking to COTS for reduced maintenance and training

costs, simplified upgrades, and much greater user

3

acceptance.

Pharmaceutical industry are today in a dilemma on how to

achieve faster ROI & lower TCO. Which approach – Home

Grown or COTS - will enable them to better address theirrequirements? Undoubtedly the relevant insight will come

when we understand “Build vs. Buy” LIMS.

Historically, LIMS vendors have designed their systems as

generically as possible in order to appeal to as wide amarket as possible across multiple industries. These

systems offered basic sample- and test-management

capabilities, but to meet industry- or application-specific

requirements, customizations were necessary. Vendors

provided tools that allowed the customer, the vendor, or

third-party consultants to extend the system and the

database.

In some industries, this approach was less problematic, as

the basic functionality was close enough to industry

2. A LIMS Primer

COTS FACTSHEET

COTS software is a hot topic because many

companies are hoping to significantly reduce the

risk of laboratory information management system

(LIMS) implementations, and subsequent

validation processes. Companies are also looking

to COTS for reduced maintenance and training

costs, simplified upgrades, and much greater user

acceptance.



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requirements that customization was not overly significant.

For the pharmaceutical industry, as well as biotechnology

and contract research organizations, however, life was not

quite that simple. Pharmaceutical researchers are workingin labs ranging from early stage drug discovery to

bioanalytical testing of drug candidates to manufacturing

development and quality control.

Applying one LIMS to those varying labs requires extensive

customization. Customization is also required due to the

batch- versus sample-oriented production processes,

complex specifications and test methods, and tight

regulatory requirements. Like a snowball, each additional

requirement would generate an avalanche of additional

work: specifications, design, development, testing and

validation, documentation, and more. Customers also ran

the risk of breaking their customizations when upgrading to

new releases.

The scenario increased the risk of failed or significantly

delayed deployments. From a timeframe perspective, past

experience with generic solutions has seen LIMS

implementations taking as long as 36 months and, in some

cases, dragging on for so long that the projects were

cancelled. It is little wonder, then, that COTS have

generated great interest in the pharmaceutical industry.

There are several interpretations for whether a software

system is COTS or not. The war of words often revolves

around “customization” versus “configuration.” Given the

challenges of our industry, and the extensive impact

associated with software customization, we define

customization as ANY manually written code that modifies

the system behavior. Whether the LIMS embeds a scripting

language or requires custom functionality to be written in an

external tool or environment, any written instructions to

create functionality represents customization – at

additional cost in time, money and resources to the

customer. This would include manually creating XML or

HTML for web-based user interfaces, or stored procedures

to automate workflow processes.

Configuration, on the other hand, offers control over the

software without requiring any additional code.

3. What is a COTS Solution?

4. Can a Pharmaceutical LIMS Really Be

COTS?

5. 100% is not possible

For years, pharmaceutical customers have been asking in

frustration why they must rebuild what they consider should

be standard functionality in their LIMS. Dissolution testing

procedures, for example, are clearly defined in the USP

and other pharmacopoeia, and have been for many years.

Yet vendors have resisted incorporating industry-specific

functionality. The commonly cited reason is that they

cannot incorporate industry-specific features into a product

that is designed to be generic enough to be sold across

industries. Currently, however, some vendors are

recognizing that solutions which satisfy the pharmaceuticalindustry’s unique needs can be mutually beneficial. After

all, the pharmaceutical industry is the LIMS industry’s

predominant market.

New COTS solutions, rather than trying to append stopgap

solutions to aging architectures, are meeting specific

business needs from scratch. Every feature that eliminates

the need for custom development work provides significant

savings during implementation and production use. Equally

important, the reduced customization allows a

pharmaceutical company to have a better grasp on actual

deployment costs and timelines, since there are far fewer

opportunities for delay when customization is minimized.

Given the current situation – pharmaceutical companies

are competing for sales in the same markets, they must

satisfy the same regulatory agencies, and they face

regulatory trends towards standardization as evidenced by

the success of the ICH -- COTS solutions do offer

multifaceted benefits. Not only do they greatly reduce

customization, COTS solutions place the burden of

following and implementing new regulatory and industry

developments and trends on the shoulders of COTS

providers. Domain expertise on the part of the vendor is

therefore critical.

There are several challenges that make a 100% COTS

solution impossible to attain, or expect, or even desire. The

sheer volume of tests and results that need to be

supported, the extensive calculations, and the wide variety

of reporting requirements are all areas of high variability



that seemingly do not mesh will with the COTS philosophy.

The objective is not to find a panacea that will meet 100% of

a company’s needs. The real objective is to minimize

customization to the maximum extent possible. The wide

variation in requirements and workflow between

companies working on small molecules or in biotech,

different routes of administration, differences between

research and development and the production world make

it virtually impossible to design a one-size-fits-all solution.

Customers should be wary of any vendor who suggests

they can provide the perfect solution with no customization

whatsoever. When examining a LIMS to assess the extent

to which they may meet your requirements, do not expect tofind a 100% fit.

A realistic assessment will always identify some areas

which represent gaps between user requirements and out-

of-the-box functionality available from the system. The

important thing, after reducing the gap as much as possible

by selecting a COTS solution, is to have a complete

understanding of the vendor’s strategy for closing theremaining functional gaps.

In addition, a COTS solution does not eliminate the burden

of responsibility on the part of the user. While the validation

effort may be greatly reduced, there will still be some effort

required to provide reassurance that the system, as

configured, is functioning according to expectations.

The past few decades have seen considerable

advancements in implementations of IT systems especially

in the extent to which such systems have evolved to ensure

21 CFR Part 11 compliance.

Change is particularly evident within the pharmaceutical

industry since drug manufacturers, more than anyone else,

require IT solutions that are increasingly responsive, less

complex and able to comply with government regulations.

The key factors that determine the strength of a packagedsolution are the solution's ability to address compatibility,

flexibility and scalability issues. Given the rapid growth in

6. 5 Key Points for LIMS Assessment

7. Deciding on the Best Software System

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heterogeneous data, the ability to organize and integrate

disparate data types is of vital importance.

LIMS ASSESSMENT KEY LIMS buyers who are promised a solution that

requires “no customization” should ask their vendor to

confirm that no additional code will need to be written.

Tools to extend the software must be available

The vendor should be able to provide experienced

analysts to assist in the deployment

The technology platform should use modern

architecture and open standards to facilitate the

required extensions.

It is also important to assess the levels of compliance

and flexibility inherent in the COTS solution.

Historically, despite extensively customizing generic

systems, pharma companies have been unable to

implement one solution to concurrently meet the

needs of the less regulated users, such as in

analytical R&D labs, and those working in tightly

monitored production laboratories. The configuration

of the system should include the definition of

compliance rules based on the type of data being

manipulated.



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Hello there. I am from HCL Technologies. We work behind the scenes, helping our customers to shiftparadigms and start revolutions. We use digital engineering to build superhuman capabilities. Wemake sure that the rate of progress far exceeds the price. And right now, 53,000 of us bright sparksare busy developing solutions for 500 customers in 18 countries across the world.

A

U T H O R

Somnath Mukherjee is head of LIMS Practice at HCL Technologies Ltd. He has over 18years of experience in the development of LIMS, its implementation and supportservices. Somnath has worked in almost all areas of LIMS, and he specializes is in thearea of interfacing LIMS with other software in an enterprise. Prior to joining HCLTechnologies, he was with worked with LabVantage Solutions Inc.

Somnath has a post graduation degree in Chemical Technology and has written inmultiple research publications on system automation.

8. Conclusions

The COTS philosophy has great appeal and providestangible benefits in the pharmaceutical world. While

pharmaceutical LIMS buyers should not seek out a 100%

off-the-shelf solution, a system that can provide as much as

85% of industry- or application-specific functionality out-of-

the-box will be a great boon to LIMS administrators, users,

and their pharmaceutical companies. The significant

reduction in deployment time and costs, as well as the

reduced risk associated with clearly defined pre-existing

functionality can change the nature of a LIMS from an

overhead expense implemented to provide regulatory

compliance to a truly effective business solution with

measurable gains in efficiency and timeliness. The LIMS

may not be a 100% COTS solution, but the drive towards

COTS is already bearing fruit, and will continue to do so as

more companies take advantage of solutions that address

the majority of their business needs, rather than requiring

customizations to do so. more companies take advantage

of solutions that address the majority of their business

needs, rather than requiring customizations to do so.

Competitive Advantage

Home Grown LIMS

1 GL LIMS

4 GL LIMS

O p e r a t i o n a l E f f i c i e n c y

HIGH

HIGH

LOW

LOW

1 GL LIMS had higheroperational efficiency butcompetitive advantage wasless because of moreCOTS elements

4 G L L I M S m i x e s C O T Scomponents and Configurable Toolsto help customer getting higheroperational efficiency (throughCOTS) along with competitiveadvantage ( through sys temconfiguration)

Home Grown LIMS hash i g h e s t O p e r a t i o n a lE f f i c i ency , bu t l ess

Competitive Advantage

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