WHITE PAPER Build v/s Buy Laboratory Information Management System
Table of Contents 1. Introduction 3 2. A LIMS Primer 3 3. What is a COTS Solution? 4 4. 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 of in-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 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 their requirements? Undoubtedly the relevant insight will come when we understand Build vs. Buy LIMS. 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. Historically, LIMS vendors have designed their systems as generically as possible in order to appeal to as wide a market 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 3
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 working in 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. 3. What is a COTS Solution? 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. 4. Can a Pharmaceutical LIMS Really Be COTS? 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 pharmaceutical industry 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. 5. 100% is not possible 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 4
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 to find a 100% fit. 6. 5 Key Points for LIMS Assessment A realistic assessment will always identify some areas which represent gaps between user requirements and outof-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 the remaining 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. 7. Deciding on the Best Software System 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. 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. The key factors that determine the strength of a packaged solution are the solution's ability to address compatibility, flexibility and scalability issues. Given the rapid growth in 5
8. Conclusions The COTS philosophy has great appeal and provides tangible 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-ofthe-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. HIGH Operational Efficiency LOW HIGH 1 GL LIMS had higher operational efficiency but competitive advantage was less because of more COTS elements 1 GL LIMS Competitive Advantage 4 G L L I M S m i x e s C O T S components and Configurable Tools to help customer getting higher operational efficiency (through COTS) along with competitive advantage (through system configuration) 4 GL LIMS Home Grown LIMS has h i g h e s t O p e r a t i o n a l E f f i c i e n c y, b u t l e s s Competitive Advantage Home Grown LIMS LOW AUTHOR Somnath Mukherjee is head of LIMS Practice at HCL Technologies Ltd. He has over 18 years of experience in the development of LIMS, its implementation and support services. Somnath has worked in almost all areas of LIMS, and he specializes is in the area of interfacing LIMS with other software in an enterprise. Prior to joining HCL Technologies, he was with worked with LabVantage Solutions Inc. Somnath has a post graduation degree in Chemical Technology and has written in multiple research publications on system automation. Hello there. I am from HCL Technologies. We work behind the scenes, helping our customers to shift paradigms and start revolutions. We use digital engineering to build superhuman capabilities. We make sure that the rate of progress far exceeds the price. And right now, 53,000 of us bright sparks are busy developing solutions for 500 customers in 18 countries across the world. lifesciences@hcl.in 6