Team JamBuster is proud to share that our iLabs is selected to showcase at BioAsia 2016. Out of about 500+ healthcare start-ups in India, about 40 or so are being selected by BioAsia for this showcase. So we are humbled.
BioAsia (http://www.2016.bioasia.in/) is the most successful and widely attended annual international Bio-pharmaceuticals events in Asia. Startup Showcase is their initiative, working with the Government of India on its Digital India program with focus on technological innovations to improve Indian healthcare.
Genesis of our iLabs software goes back to one of our BOT contract, during which we developed an inventory software to track thousands of telecom testing equipment.
In 2012, the U.S. Food and Drug Administration (FDA) filed an injunction against an Indian generic drug manufacturer because they attempted to retest raw materials and finished APIs after the initial items had failed analytical testing. This might not have been so bad if the company didn’t also attempt to manipulate the electronic record to cover up the outcome of the first attempt. As penalty for the flagrant compliance violation and data manipulation, the FDA banned that company from manufacturing drugs for the U.S. market. This case illustrated the critical need of the digital records in the modern laboratory environment.
Both U.S. and European Union (EU) regulators recognize the growing importance of electronic submission and have created ways for digital transactions to occur. However, these regulators also maintain that good laboratory practices ((GLP) must ensure that submitted data is accurate, and free of errors and manipulation. Both U.S. and EU regulators have provided guidance regarding data integrity and the use of audit trails. The specific details can be found in in FDA 21 CFR 11 and EU GMP Annex 11.
Observing these headwinds, one of the Iconic Indian Pharma leader approached us to develop a Laboratory Asset Management software using our inventory software. Working with them and input from multiple Industry experts, iLabs was developed with first version distributed by October 2014. iLabs leverages the FDA 21 CFR 11 & EU GMP Annex 11 standards, which demands that an audit trail must be secure, timestamped, computer generated and must not delete or obscure previous data.
Recently, our software has gone through extensive validation testing at this iconic Pharma leader’s R&D Lab and is in commercial use over past three months. Kudos to JamBuster’s team members, Milind (Development), Nimisha & Anita (QA) who provided Developmental and Validation server testing support for this activity, before the Production Go-Live. Apart from digital audit-trail, another big advantage of the such digital system, is quick look-up of item(s), purchase triggers and ability to locate the corporate asset, all resulting into savings.
We are happy that our small Pune company is helping Indian Pharma Giants to go digital and provide complete traceability for their R&D and QA Laboratory Assets.
So we invite you all to come visit us at our booth at BioAsia, February 9-10, 2016 in Hyderabad, India. If you can’t make it to Hyderabad, just drops us an email for a demo at email@example.com