Value Add

Value Add

LabWare begins to reap the rewards for five years of investment in India

Dr Bob Hillhouse, Managing Director, LabWare, discusses Laboratory Information Management System (LIMS) and LabWare’s approach towards the Indian and global market

The early years

My love affair with India goes back to the 1970s when I lived in Mumbai for a period during my research days. Many colleagues became lifelong friends and they followed me back to Europe and the USA. Our children have grown up together and it is great to see many of them beginning to return back to India to enjoy their roots and culture.

My love affair with LIMS started in the early 1980’s when I successfully persuaded the British government (National Computer Centre) to fund the development of a LIMS. At the time I was the managing director of a VG Instruments mass spectrometry company and had been asked by the group to take a look at the software informatics division that had developed an enterprise level chromatography data system. Following ten highly successful years this group was acquired by a large US instrument company. Leveraging my entrepreneurial roots, I looked for new challenges and decided to join forces with the best software developer in the Informatics business. LabWare LIMS was developed in the early 1990s and was introduced into Merck Pharmaceuticals and Kraft Foods in 1995. In the last ten years LabWare LIMS has gone on to become the most successful LIMS product and become the global standard for LIMS.

Evolution of the laboratory

LIMS has evolved a lot in the last 20 years. It used to be that labs were a separate part of the business, an island within the business. Laboratories were generally considered as internal services, which generated no money and were run by scientists in white coats. In this environment, a main business objective associated with the lab was to control costs, so luxuries such as a dedicated LIMS software was not a priority. Today, the lab has become an integral part of the whole business. Laboratory managers tend to have business backgrounds (or at least an understanding of the bigger picture) and one can even find labs that generate money as external labs.

LIMS has evolved in tandem with the labs. In the days when the lab was an island, LIMS was also an island. LIMS would usually not communicate with other business systems (such as Material Requirement Planning and Process Control Systems) and the end users of LIMS were normally just the chemists and other lab personnel. Nowadays, a mainstream LIMS should offer a variety of interfaces, and LIMS is used by many people who are not working in the lab. LIMS has become part of the enterprise.

One example of this change is that LIMS is one of the few business systems that is used from the very beginning to the very end of a product’s life cycle, the so called ‘cradle to grave’. For example, when a company is developing a new product, LIMS is used to test the prototype materials. When the product development is complete, LIMS will be involved in the testing the scaling up of the manufacturing. As the product is manufactured, LIMS will manage the testing and release to market. Later on, LIMS can be used to test any complaints samples. In fact, in some industries, LIMS is used for testing samples for many years after the product was made and shipped, generally as a legal requirement.

LIMS Product

Many LIMS products have not stood the test of time because either a failing of flexibility, poor technical architecture and/or lack of investment. Indeed many large corporations have attempted to develop LIMS and there are numerous examples that can be quoted. LIMS is a deceptive technology that requires cross discipline knowledge to address in comprehensive manner. In addition, regulatory and business requirements require the storage of historical data over long periods of time.

Upgrade of new software versions has become a hot potato in the LIMS industry. Historically, many LIMS products have required massive upgrade efforts and associated validation costs. This has resulted in many LIMS not being upgraded in a timely manner and often not at all. In fact, LabWare specialise in the replacement of legacy LIMS and we have an extensive reference list of replacements of all of the major competitive LIMS.

LabWare revolutionised the LIMS industry back in the mid 1990s with the introduction of a configurable LIMS where the data and configuration is stored in the LIMS database. At the same time, the core LIMS code was separated from the configuration layer so that every customer had the same version of software worldwide. The core code is isolated from the configuration and allows systems to be implemented without modification of the core product code. Not only does this reduce validation efforts but it also allows LabWare to provide upgrade tools to convert systems to the new version with a few man days of effort. For example, McNeil Pharmaceuticals in Sweden installed LabWare LIMS in 1996 and are still running the latest software, all with a few days upgrade effort.

LabWare LIMS is a scaleable architecture and has a proven track record both in decentralized and centralized, global enterprise installations. This architecture simultaneously encompasses diverse requirements, multi-lingual support, and high level security across many different time zones and applications. The LabWare LIMS client runs on any contemporary Windows version or in a browser including Safari, Mozilla FireFox, Opera or Internet Explorer. Our web server component may be any J2EE web server, including those available as open source. The database server component may be installed on anything from Windows to UNIX to Linux, and may utilize any relational database from Oracle to SQL Server to DB2.

Hundreds of customers are operational in both highly regulated and non-regulated environments. LabWare LIMS meets all GLP requirements by providing full sample tracking, user certification, instrument and calibration management, standards & reagents management, full auditing, CFR21 Part 11, report and sample scheduling, bar coding, on-line help, and many other functions. LabWare provides an unparalleled range of standard functionality to all users and delivers comprehensive capability and compliance, with no compromise.

Routine management reports, secure reports, data mining and fingertip production of graphical reports allow many type of users easy access to information. Over many years LabWare has worked in partnership with both their customers and best-of-breed suppliers, to deliver the paperless laboratory environment. Sophisticated bi-directional integration to the Waters Empower CDS, the NuGenesis SDMS, SAP and the NWA Quality Analyst show the ongoing level of commitment of LabWare towards this challenging goal.

LabWare LIMS wins many industry awards for not just LabWare LIMS but also Instrument Interfacing and Networking using the integrated LabStation technology that allows any analytical instrument to acquire data easily into the LIMS database.

http://www.scientificcomputing.com/2008_Readers_Choice_Awards.aspx

Included in the LabWare pricing policy is access to all LabWare modules including LabStation, every module mentioned above and many more. Customers who started out using client server using Oracle can switch to Microsoft SQL Server, or vice versa, integrate to SAP, integrate to NuGenesis or switch to Web 2.0 using a full function browser without any additional license cost implications.

LabWare’s upgrade record is unique among the major LIMS vendors and is a major reason why LabWare LIMS is the best selling LIMS in the pharmaceutical industry and why LabWare has more momentum than any other vendor. Please visit our website and see the list of customers which is published online.

http://www.labware.com/l
wweb.nsf/lp/en090604

LIMS Implementation & Support

Successful LIMS implementations require more than a great product. LabWare offers a full complement of services to support customers throughout the project life cycle and have staff based in India.

Another important part of our growth strategy has been the development of industry template solutions that build pre-configured applications on top of our highly flexible, acclaimed LabWare LIMS product. There are a number of industry templates and the LabWare pharmaceutical template includes QA/QC manufacturing, stability testing and environmental monitoring.

Manufacturing has been moving off-shore to lower cost locations worldwide. European and US locations have been under pressure to add value higher up the delivery chain and manufacturing has grown in the tiger economies, Latin America, North Africa and Eastern Europe. LabWare have a large global userbase that includes many of the world’s leading pharmaceutical companies such as Wyeth, Schering Plough, Teva, AstraZeneca, Pfizer, McNeil, Merck, GSK Biologicals, Sanofi Pasteur, Novartis, Zentiva, Hoffman La Roche, Bristol Myers Squibb, Boehringer Ingelheim, CSL, Takeda, Genentech, UCB, Astellas, Watson, Cephalon, Forest Laboratories, Gilead Sciences, Allergan, Biogen Idec, Lundbeck, Shire, Solvay, Shionogi, Eisai, Sankyo, Nycomed, Mylan Laboratories, to name but a few of our extensive corporate userbase.

In India our pharmaceutical customers include Lupin, Strides Arco, Johnson & Johnson and Apotex. Our Indian staff has been involved in the installation of LIMS both in India and other worldwide sites.

In addition to support provided directly by LabWare, we enable sharing of expertise between our customers. Since LabWare LIMS is configuration driven and includes all functionality in the base product, our customers can relate to each other from a common point of reference. This philosophy of transparency, with free flow of knowledge, truly empowers users, and makes them part of a global community. This has been a very successful part of LabWare’s growth strategy.

The following chart gives an indication of the main business systems used during the phases mentioned above.

Product Phase

Main Business System(s)

LIMS used?

Development Electronic Document Management Systems (EDMS) Yes
Pilot Plant/Scale up Project Management (PM) Yes
Raw Materials Purchasing Material Management Planning (MRP) Enterprise Resource Planning (ERP) Yes
Production Manufacturing Execution System (MES). Process Control System (PCS), Electronic Batch Record (EBR) Yes
Distribution Enterprise Resource Planning (ERP) Yes
Complaints/Retesting Customer Relationship Management (CRM) Yes
Long Term Several (often paper!) Testing/Stability/Shelf-Life Yes

Regulatory Compliance

LabWare LIMS is designed from the ground up with the regulated industries in mind, such as the Pharmaceutical and Environmental industries. In order to achieve this, LabWare LIMS has needed to comply with all applicable regulatory guidelines and rulings, such as GMP, GLP, GCP and others (generally grouped together as GxP). In addition, we have ensured that requirements in other regulations such as 21 CFR Part 11, ISO 17025 and various national rulings are completely covered within LabWare LIMS.

LabWare has taken all of the applicable requirements and made sure that all of the possible technical controls are included within LabWare LIMS. For example, 21 CFR Parts 11, 50, 58, 210 211 and 820 are fully addressed within the LabWare LIMS solution. This is also the case with regional bodies such as Europe’s EMEA and national bodies such as the Japanese MHLW.

A key element to regulatory compliance is that LabWare LIMS is a fully validated system within our customers’ sites. We accomplish this by adhering to the concepts within Good Automated Manufacturing Practices (GAMP). GAMP defines categories of software that affect the amount and depth of validation work that the customer should perform. LabWare LIMS qualifies as a Category 4 application, as it is a configurable system, where customization is not necessary.

In order to help our customers reach the right level of validation, LabWare provides extensive material such as:

  • Example Validation Plans

  • Automated Installation Qualification (IQ)

  • Operational Qualification (OQ)

  • Examples of Performance Qualification (PQ)

  • Examples of System Administration SOPs

LabWare will remain at the forefront as new regulations emerge, by having a very active involvement with both customers and regulators. LabWare frequently presents at international conferences and runs training seminars on the issue. LabWare LIMS includes several features designed for regulatory compliance, such as Analyst Certification and Business Rules. These features have value even for customers who are not regulated, because it introduces useful security concepts for any lab.

Taking a long term view

Initially LabWare LIMS was introduced into India as part of global roll outs and there is still an element of this from our large global installed base. In 1999 GE Plastics in Bangalore (The John F. Welch Technology Centre) installed LabWare LIMS and we believe that this site is still the largest LIMS installation in India. In 2003 VIMTA Laboratories installed a LIMS in Hyderabad and purchased a LabWare LIMS to replace a previous commercial LIMS. LabWare employed a team of three staff to nucleate our Indian business and it soon became obvious that the Indian market was at an early stage of development and that regulatory requirements would take time to become important in India. Following the adoption of the World Trade Organization (WTO) in 1995 it has taken some time for the Indian market to react. TRIPS has generated a huge controversy in India and abroad. However, things are beginning to change and LIMS is now a hot technology in India.

LabWare decided to take a long term view and build a world class LIMS facility in India. Although a number of new LIMS were installed in the metals and petrochemicals industry, the pharmaceutical industry in India was sluggish to invest in new LIMS technology. LabWare established a 6,000 sq ft office in Saltlake, Kolkata and pre-sales staff in Mumbai. In addition to Indian sales & implementation staff, the Indian team provides documentation and testing support to the US development team and also provides a knowledge centre for LabWare’s global operations. During the last five years LabWare have built and established a team of LIMS professionals that have been involved in the development of our business in both Europe and the Middle East. We are now well positioned to take advantage of our investment.

In Saudi Arabia LabWare have dominated the LIMS industry and since 9/11 we have replaced the majority of commercial LIMS installed in the Kingdom’s petrochemical industry. This includes all of Saudi Aramco’s refineries and gas sites and every SABIC manufacturing site. Outside the Kingdom our Indian team has installed systems in Dubai, Oman and Abu Dhabi. They have contributed to our global success in the region.

The corporate LIMS at Lupin and Strides Arco have been driven and installed by our Indian team and both LIMS integrate to SAP using QM-IDI. LabWare have a full suite of Web Services that integrate with SAP Netweaver. LabWare are working with SAP Americas to provide an ES Bundle for QM-IDI functionality. Expertise for both LIMS and SAP integration exists within our existing team.

The immediate future

LabWare also supplies LIMS into the CRO market and Covance, Quintiles and Sonic Healthcare are among our corporate customers. Other users of our Clinical Trials software (phase1, 2 & 3) include Pfizer, GSK Biologicals and Mayo Clinic.

The Indian pharmaceutical industry, with US$4 billion in domestic sales and over US$3 billion in exports, is growing in terms of infrastructure development and technology. The industry now produces bulk drugs belonging to all major therapeutic groups requiring complicated manufacturing processes and has also developed excellent ‘good manufacturing practices’ (GMP) compliant facilities for the production of different dosage forms. The strength of the industry is in developing cost-effective technologies in the shortest possible time for drug intermediates and bulk actives without compromising on quality. This is realized through the country’s strengths in organic synthesis and process engineering. LabWare LIMS is a key technology that can help Indian companies in their quest for growth and access to international markets. Proven LIMS technology combined with local resources and support provides a unique opportunity for the Indian pharmaceutical industry.

During 2008 LabWare are running LIMS Seminars in Mumbai, Hyderabad, Bangalore, Delhi and Chennai in October and December. I look forward to meeting new contacts and friends during these seminar events.

For more information please visit our website or contact India Sales at +91 9930121612.