Ocimum unveils new software product to manage quality processes in biopharma industry

PharmaTracker supports exhaustive tracking and robust management of quality control and assurance process and the data generated in an API or drug manufacturing environment

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Hyderabad: Ocimum Biosolutions, a leading provider of life sciences Laboratory Information Management Systems (LIMS), has announced the release of PharmaTracker, which supports QA/QC process and data management in pharmaceutical companies for regulatory markets.

According to Mr Subash Lingareddy, President, Ocimum Biosolutions, “PharmaTracker is our software offering to serve Pharmaceutical companies in managing their quality control procedures across the process of API and drug manufacturing. This software also serves the regulatory needs of data capturing and management and is available on a private or hosted cloud.  The software is priced under Rs 100,000(US$ 1,500) per site per month for unlimited licenses for Indian companies and can be accessed on the cloud enabling senior managers to keep control of the system remotely”.

Mr Sridhar Reddy, Senior Vice-President, Bio-IT said, “We are excited about the release of PharmaTracker and are confident of its capabilities in meeting all the requirements of a regular QA/QC lab. We have designed  PharmaTracker based on our 14+ years of experience in handling lab data management, process automation and analytics”.

How does the product work?  

PharmaTracker supports exhaustive tracking and robust management of quality control and assurance process and the data generated in an API or drug manufacturing environment. The system allows creation and maintenance of master records including material masters and test masters, registration of new lots/batches of raw-materials, intermediate and finished products, sampling procedure, test execution, handling OOS, stability tests management, task scheduling and management, review & approval routing, inventory and instrument management, etc., in addition to maintenance of complete audit trails, electronic signatures and role based access to users, the features that make this system compliant with US FDA 21 CFR Part 11 regulations.

Ocimum Biosolutions is known as a comprehensive Integrated Life Science Informatics solutions provider with service offerings that span across Sample and Data Management (LIMS, Biologics Data Management), Data Analysis Services, Databases (BioExpress®, ToxExpress®) and Bio-IT consulting services.