Cary, NC (PRWEB) February 28, 2013
InstantGMP-Lite EBR is an electronic batch record software system for cGMP manufacturing that has been in a beta testing phase for the past 4 months. That phase has now been completed and a thoroughly revised version will now undergo additional validation testing before being released next month.
Multiple manufacturing sites were involved in the evaluation of this electronic batch record software. The beta sites ranged from manufacturers of dietary supplements to OTCs to drug/device combinations. Each site was able to provide valuable feedback that was adopted in the updated design of the system. The result is a cloud-based software that is focused on making manufacturing of dietary supplement and pharmaceutical products easy.
One of the primary features that was designed into the application is the compliance with FDA regulations such as Good Manufacturing Practices and 21 CFR Part 11 electronic records. The required quality checks that are necessary to be in compliance are programmed into the software to make compliance easy.
The majority of the feedback received was on the Master Manufacturing Records and Batch Production Record functions. The users liked the ability to record master manufacturing formulas easily and to have them under version control. They also appreciated that they could fill out the batch production records in real time and add digital signatures that recorded the date and time when each activity was completed. Most of all they were impressed that it was easy to keep their GMP information securely stored in the cloud where it was assessable remotely from any location.
A new product launch of InstantGMP-Lite EBR is scheduled for March, 2013. The updated version will be offered as SaaS (Software a
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