HCL Launches Application For Pharma Sector
HCL Technologies has recently announced the launch of Equipment Log Manager (ELM), a .NET based application that will enable pharmaceutical companies to comply with the Current Good Manufacturing Practice (cGMP) guidelines of the FDA.
The ELM is designed specifically for Indian pharma companies looking to get their manufacturing facilities GMP complaint. The web-based application addresses the cGMP subpart of the FDA guidelines pertaining to equipments i.e. equipment cleaning and usage log of all major equipments.
The cGMP regulations require drug manufacturers to maintain standard operating procedures (SOPs), which detail every step of a drug’s manufacturing process.
The ELM offers following capabilities to users:
* 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 is also working on other Logs addressing features related to electronic signatures (21 CFR Part 11 Compliance) and Validation System for Procedures to offer a more comprehensive set of solution for the pharma industry in the compliance space.
The recent rise in the number of small and mid-sized pharmaceutical companies pushing for contract manufacturing and global sourcing for supply of bulk drugs for multinational corporations, has meant that local drug manufacturers need to upgrade their manufacturing standards and conform to cGMP guidelines.
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