CCE Software's Laboratory Information Management System (LIMS) has made its presence felt in the potential Indian and South East Asian markets since its launch in late 2001. Cashing in the demand for LIMS, the company has also introduced a new module titled Environmental Monitoring System, which is a valuable addition for the pharma-biotech and medical devices sector where it is particularly useful in the Quality Assurance (QA) and Quality Control (QC). It has also been doing validation assignments - Install Operational and Performance Quality for pharma companies as per US FDA (United States Food and Drug Administration).

LIMS is designed to offer 21 CFR Part 11, which is a validation to comply with US FDA norms. The use of the product by the Indian pharma-biotech sector would help achieve International Regulatory Compliance for the products to be marketed globally. The complete range of LIMS covers stability programme, raw material analyser, finished product analyser, preventive maintenance and calibration module and automated packaging component analyser. The primary focus of the CCE with LIMS is on lab automation and research & development and not manufacturing process as the entire audit by regulatory authorities takes place in QA and QC.

"Between late 2001 and now, we have been engaged in creating an awareness among the pharmaceutical companies on the importance of WTO (World Trade Organisation) and US FDA compliance. In fact it took quite a while for the sector to wake-up to this requirement, Ashis Dutta, director of CCE Software Group told Pharmabiz.com.

There has been a positive response over a period of time towards the need for compliance, which has resulted in investments by the pharma-biotech sector who are now approaching CCE for LIMS, said Dutta.

"We created an awareness and comprehension of the product among the industry to help compete in the WTO regime and we did not look at merely selling the product," informed Bharat Prabhu, business development manager, CCE Software Group.

LIMS is installed in India at Dr. Reddys Laboratories in Hyderabad and US Vitamins in Mumbai. The company is continuing dialogues with Ranbaxy and a host of others.

The new module on environment monitoring system was created as the pharma-biotech sector was hiring dedicated environmental engineers for whom the use module is essential.

One of the marketing strategies adopted by the company is to exhibit the product at trade shows where the regulatory officials from US-FDA and MCA, UK participated. The officials are impressed by LIMS and have recommended the product to pharma-biotech companies, said Prabhu.

India is a huge market for LIMS and Bangalore is the hub for the South East Asian markets, particularly Malaysia, Singapore and Philippines. "There is a lot of work to be done here in India itself as we are now in the process of getting orders from our business development efforts. We will slowly increase our presence to other parts of the world," informed Dutta.

A typical user of LIMS needs to invest to the tune of US$26,000 for the package, validation and user training programme although LIMS is priced at US$20,000. The cost is attributed to the development of the software to withstand the FDA audit. "Infact, the cost depends on the module and we call it a modular investment as it address each area of lab management in the module," said Prabhu.

CCE has competition in India from Lab Vantage and Labware. The only difference between LIMS and the competitor's offering is that we cover the total laboratory in design and development of the software in a modular fashion with a fully validated system, informed Dutta.

CCE is looking at investment in terms of manpower and infrastructure to be fully geared for the Indian market, informed Dutta.