Compliance needs driving new technology opportunities in the pharma market
London UK - 5th September 2006: HCL Technologies Ltd. (HCL), one of India's leading global IT services companies, today announced the launch of its Equipment Log Manager, a Web-based application built on the .NET technology. The application is designed for pharmaceutical manufacturers that are required to comply with the Current Good Manufacturing Practice (cGMP) guidelines mandated by the UK MCA U.S. FDA and the South African MCC.
Current Good Manufacturing Practice (cGMP) compliance is essential, since FDA approval for drugs are based on the final product quality, as well as audits and inspections of manufacturing facilities that prove the manufacturer's capability to produce drugs on a consistently high quality.
To comply with cGMP regulations, manufacturers are required to maintain standard operating procedures (SOPs) that detail every step of a drug's manufacturing process. In recent times, the Indian pharmaceutical industry has witnessed the emergence of a number of globally competitive, small and mid-sized pharmaceutical companies with high growth potential. Indian pharmaceutical companies are pursuing contract manufacturing and global sourcing for supply of bulk drugs and intermediates for multinational corporations. With an eye on the global outsourcing opportunity, a number of Indian companies have realized the need to upgrade manufacturing facilities, which are GMP compliant.
"Our ELM application will help Indian pharmaceutical companies that are aiming for GMP compliance," said Pradep Nair, head of the global life sciences and healthcare practice at HCL. "The application is part of HCL's evolutionary software development approach, which initially addresses the cGMP subpart dealing with equipment."
The ELM Web-based application specifically deals with the requirements related to the equipment cleaning and usage log for all major equipments. In the subsequent phases of the HCL's development project, other logs addressing features related to electronic signatures (21 CFR Part 11 Compliance) and validation system for procedures will be developed.
The ELM application has the following capabilities:
• Assign and operate tasks
• Manage users & roles, products, equipments
• Manage sop activities and intermediate materials
• Enforce job sequencing of activities in an sop
• Manage batches under production
• Maintain equipment cleaning and usage logs
• Maintain calibration, inspection and maintenance logs of equipments
• Print, view and export equipment logs to different file formats
• Alerts and notifications
• Support for localization and internationalization
HCL's Life Sciences and Healthcare practice provides composite solutions to customers in the areas of Biomedical Informatics, Clinical Pharmacogenomics, Clinical Trial Management Solutions, Medical Devices and Hospital Management Systems in compliance with FDA regulations, and enables customers and partners to enrich the quality of patient lives through HCL's innovative IT Solutions.
About HCL's Life Sciences & Healthcare Practice
Life Sciences & Healthcare practice at HCL delivers IT centric solutions across the pharmaceutical, medical device and hospital industries. The DNA of the practice lies in extension of this knowledge to provide focused IT services and solutions to the customers. HCL's investments have strong focus on regulatory compliance prescribed by FDA's CFR, CEC, ISO, HIPAA and meeting technology paradigms surrounding HL7, DICOM, and others. HCL continues to invest in providing tested solutions in thought leadership arenas like Pharmacogenomics, medical devices and diagnostics, contract manufacturing, and hospital information systems. The Life Sciences & healthcare team comprises 1200 people including regulatory experts, bio technologists, pharmaceutical industry experts etc. HCL is already working with 9 of the top 15 leading global pharmaceutical companies including Novartis, Aventis etc.
About HCL Technologies
HCL Technologies is one of India's leading global IT Services companies, providing software-led IT solutions, remote infrastructure management services and BPO. Having made a foray into the global IT landscape in 1999 after its IPO, HCL Technologies focuses on Transformational Outsourcing, working with clients in areas that impact and re-define the core of their business. The company leverages an extensive global offshore infrastructure and its global network of offices in 16 countries to deliver solutions across select verticals including Financial Services, Retail & Consumer, Life Sciences Aerospace, Automotive, Semiconductors, Telecom and MPE (Media Publishing & Entertainment). For the twelve-month period ended 30th June 2006, HCL Technologies, along with its subsidiaries, had revenues of US $976 million (Rs. 4,388 crore) and employed 32,626 professionals. For more information, please visit www.hcltech.com
About HCL Enterprise
HCL Enterprise is a leading global technology and IT enterprise with annual revenues of US $3.5 billion (Rs. 15,000 crores). The HCL Enterprise comprises two companies listed in India - HCL Technologies & HCL Infosystems. The 3-decade-old enterprise, founded in 1976, is India's original IT garage start-up. Its range of offerings span Product Engineering, Technology and Application Services, BPO, Infrastructure Services, IT Hardware, Systems Integration, and distribution of ICT products. The HCL team comprises 36,949 professionals of diverse nationalities, who operate from 16 countries including 300 points of presence in India. HCL has global partnerships with several leading Fortune 1000 firms, including leading IT and Technology firms. For more information please visit www.hcl.in
Forward Looking Statements
Certain statements in this release are forward-looking statements, which involve a number of risks, and uncertainties that could cause actual results to differ materially from those in such forward-looking statements. The risks and uncertainties relating to these statements include, but are not limited to, risks and uncertainties regarding fluctuations in earnings, our ability to manage growth, intense competition in IT services including those factors which may affect our cost advantage, wage increases in India, our ability to attract and retain highly skilled professionals, time and cost overruns on fixed-price, fixed-time frame contracts, client concentration, restrictions on immigration, our ability to manage our international operations, reduced demand for technology in our key focus areas, disruptions in telecommunication networks, our ability to successfully complete and integrate potential acquisitions, liability for damages on our service contracts, the success of the companies/ entities in which we have made strategic investments, withdrawal of governmental fiscal incentives, political instability, legal restrictions on raising capital or acquiring companies outside India, and unauthorized use of our intellectual property and general economic conditions affecting our industry. The company does not undertake to update any forward-looking statement that may be made from time to time by or on behalf of the company.
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