LIMS: From Laboratory to Management

Pharmaceutical companies need tools that help them to improve enterprise-wide communications, reach critical decisions faster and produce timely, accurate reports on how compounds are progressing. These goals need to be achieved while maximizing return on investment, shortening the pipeline life cycle and cutting costs.

System Integration

The challenge is to successfully streamline and integrate the flow of data so that management has the information that they need to make timely decisions. Pharmaceutical companies should not delay the implementation of next generation tools to help them to manage the increasing amount of data that is generated by their organizations. The solution begins with a purpose-built, enterprise-level Laboratory Information Management System (LIMS). Working with multiple, disparate systems with minimal to no integration is not a viable option.

Historically, industry standard LIMS have only delivered 30-40 percent of specific functionality that is targeted to each user’s needs, requiring extensive customization to make that LIMS function in that particular setting. Such customization is commonly only possible through the use of proprietary programming languages that are developed and provided by the vendor.

The combination of minimal industry-specific functionality and often out-dated and/or costly proprietary languages has been particularly troublesome in the pharmaceutical industry. In addition, pharmaceutical laboratories normally create their own user documentation, design documentation, validation scripts, and help files. As a consequence, the implementation of LIMS in various laboratory settings has often been a long, costly and painful process not only during installation, but also in operating and maintaining the system over the years.

The growing mandates of global regulatory compliance and long-term data traceability, as well as the complexity of laboratory testing and emphasis on batch versus sample management, have forced pharmaceutical manufacturers into lengthy, expensive adaptations of generic LIMS to meet their specific requirements.

Extensive and costly customization, validation and implementation periods, in many cases lasting 36 months or more, have become routine, resulting in decreased productivity. However, with the increasingly higher costs of bringing a new drug to market, pharmaceutical manufacturers cannot afford delaying the implementation of next generation tools that will increase productivity.

The Business Challenge

With drug development times of approximately 15 years and subsequent costs approaching US$2 billion by 2010, pharmaceutical companies are increasingly in search of processes that can help them to consistently deliver a return on investment during the patent life of a drug.

Enterprise-level LIMS are key contributors in this effort. Delivering functionality that is specific to each stage of the drug development process, purpose-built LIMS streamline processes help to reduce costs, and present organizations with unique integration opportunities.

Such systems deliver real-time analysis and reports, and facilitate regulatory compliance and product quality. They also integrate with the company’s broader network and provide secure access to key data throughout the organization.

Purpose-built LIMS for pharmaceutical applications are particularly relevant. According to the 2008 “Strategic Analysis of the US Laboratory Information Management Systems Market” by Frost & Sullivan, preconfigured solutions with test methods for specified industries will drive growth across all markets.

Greater functionality in the out-of-the-box core product means less risk, lower costs and less time involved in the implementation, validation and support of the applications. The objective of purpose-built LIMS solutions is to deliver as much domain-specific functionality as possible that addresses the critical needs of the laboratory and delivers the increased enterprise-level access that multi-site/ multi-user organizations are looking for.

According to the same report, market growth indicators for solutions providers are focused on providing customers not only with purpose-built systems that are fully integrated with other laboratory equipment, but also with LIMS that easily align with global enterprise solutions.

Facilitating Data Management

A coherent strategy that can integrate data from a LIMS, Chromatography Data System (CDS), Enterprise Resource Planning (ERP), Manufacturing Enterprise System (MES), Electronic Laboratory Notebooks (ELN), and other sources across the enterprise is a key business driver.

Modern LIMS serve as common platform frameworks that other informatics solutions, instrumentation, enterprise systems and enterprise communications tools can plug into to share common functions, without having to build them from scratch for each product.

Seamless enterprise-wide integration is a necessity because it enables key knowledge originating in the laboratory to be available to management in real-time. Integrating the enterprise will facilitate better planning, data quality, collaboration and end-to-end report generation, all with the goal of providing management dashboard views of key business metrics – which are essential to effectively run operations, and thereby enabling management to have the critical data they need before, not after, any point of crisis.

The world of laboratory informatics is changing to meet the needs of pharmaceutical companies, which are continually searching for ways to reduce costs, accelerate time-tomarket and respond to increasing regulatory requirements. LIMS can help pharmaceutical companies to respond with greater certainty to the unforeseen challenges that can often make or break a company.

Enterprise level integration is particularly relevant in today’s business climate where near instantaneous response is required by pharmaceutical companies to protect the public and the environment. LIMS can help to bring key business knowledge originating in the laboratory to management at all levels of the enterprise.