Medical Device Manufacturing Software
Medical Device companies are required to produce products using Good Manufacturing Practices. InstantGMP™ QSR is a Cloud based Manufacturing Execution System for medical devices that makes manufacturing and regulatory compliance easy.
InstantGMP™ QSR provides a complete GMP manufacturing solution throughout your facility, across multiple functional divisions and across all sites. Standardized Manufacturing SOPs and policies that support the QSR system are available on our site so creating your completely documented quality system can be accomplished in weeks instead of months. Validation is done to meet the FDA's standards for producing medical devices. All other requirements for manufacturing medical devices are programmed into the application so GMP compliance is automated, taking the strain off of Quality Assurance personnel. The application effectively manages all of your electronic Device Master Records and Design History Files. These capabilities when combined in our application can make responding to a compliance letter or audit a routine process. Additional benefits are:
- Cloud computing allows access to your records anytime from any place
- Get immediate access to inventory and manufacturing information
- Shorten timelines in production
- Create easy to follow manufacturing processes
- Make quality assurance reviews effortless
- Connect Design History Files to Master Device Records
- Reduce errors in production
- Eliminate software validation at your site because cloud application is already validated
To summarize, InstantGMP™ QSR is a part 11 compliant Manufacturing Execution System with electronic batch records that streamlines the entire process of manufacturing medical devices made under Good Manufacturing Practices (GMP). It simplifies the documentation and approval procedures to reduce production times. The Device Master Records and the Device History Files are managed within the software to prevent errors, maximize quality and assure GMP compliance. All data can be viewed remotely from any location and has individualized security settings on every screen. The net result is better efficiency and higher quality than can be achieved with paper based systems.
Compliance with GAMP 5, 21 CFR Part 11 and Part 820 makes this manufacturing software ideal for producing finished medical device products.