HCL Technologies has launched 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 US FDA. 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 realised the need to upgrade manufacturing facilities, which are GMP compliant and have approvals from US FDA, the UK MCA, and the South African MCC.

"Our ELM application will help Indian pharmaceutical companies that are aiming for GMP compliance," said Pradep Nair, head Global Life Sciences and Healthcare practice at the company. "The application is part of HCL's evolutionary software development approach, which initially addresses the cGMP subpart dealing with equipments."

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 company'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 capabilities such as assign and operate tasks; manage users and roles, products, equipments; manage SOP activities and intermediate materials; enforce job sequencing of activities in a 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; and support for localisation and internationalisation.

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.

The company's life sciences and healthcare division 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 US FDA regulations, and enables customers and partners to enrich the quality of patient lives through the company's innovative IT Solutions.