InstantGMP™ provides opportunities for shorter manufacturing lead times, fewer transcription errors, improvements in productivity and reductions in overall costs.
Cary, NC (PRWEB) February 28, 2012
InstantGMP is an electronic batch record software system that is specifically designed for small to mid-size pharmaceutical operations. It is the only EBR system that comes with a complete set of standard operating procedures (SOPs) that govern the end to end process of manufacturing GMP products or other regulated materials. The requirements of the quality system and the SOP requirements are hard coded into the database application to make transition from paper based manufacturing easy and to improve compliance and productivity.
InstantGMP was originally designed by a team of manufacturing and quality experts in 2004. Version 1.0 was released in 2005 as a client/server application. Three years later, the development of web-based version 2.0 that would improve user-friendliness and visibility was begun. This version allows anyone to view their data and statuses from any internet connection which allows companies to stay virtual and still be in control. At the same time, the Standard Operation Procedures that govern manufacturing were updated and their new requirements were incorporated into the application. This approach allows new users to quickly implement the application at their manufacturing site with a minimum of disruption and transition.
While the electronic batch records are at the heart of this system, it provides the functionality of a manufacturing execution system. Inventory control as well as equipment and room logs, and purchasing functions are included. Version control is provided for materials, specifications and Master Batch Records. Project definitions, team assignments and security control are also incorporated. The software is 21 CFR Part 11 compliant and test scripts are available for user validation.
The entire InstantGMP system upgrade to makes it easy for small and mid-size pharmaceutical operations to get started and to take advantage of the productivity enhancements that electronic batch record systems can provide.
Instant GMP™ is a web-based Part 11 compliant manufacturing execution system for that streamlines the entire process of pharmaceutical manufacturing. It simplifies the documentation and approval procedures to reduce production times. Its hard coded quality assurance procedures are built in to prevent errors and to maximize quality and to assure GMP compliance. It can be accessed remotely from any location and has security settings on each screen that let it be viewed by anyone while maintaining full data protection.