Overcome regulatory constraints with Paperless Manufacturing. FDA Regulated companies turn to CIMx Software for proven solutions to the challenges facing regulated industries. These companies benefit from the most secure system available for creating, maintaining and archiving interactive data required by regulated agencies, with a solution that meets all 21 CFR Part 11 requirements for electronic records.
In addition, the FDA requires specific data collected on medical devices, packaged goods, food or pharmaceuticals, to assure each lot meets quality control profiles and product specifications. The BPR data and laboratory test results are collected to support audits and traceability, minimizing the cost and complexity of audits through CIMx Software’s paperless manufacturing solution. A simple method of recording production samples and automatically maintaining records to meet FDA guidelines..
"I can't emphasize enough that CIMx's background in process planning really got us over the hump. We were actually going to go the route of having a system custom-developed for us..."
Close the production loop at a single location or across the entire enterprise while providing the foundation for Smart Manufacturing with Quantum MES.
For more than 20 years, CIMx has been a leading provider of innovative solutions for manufacturers. Quantum Paperless Manufacturing has the solutions your industry has been waiting for because Quantum was designed with the needs of the manufacturer at its core.
A government contracted manufacturer had a new plant opening in 5 weeks. There was an immediate need for distribution and management of work instructions. CIMx was also able to provide the ability to collect precision machining data on complex parts with support through a remote IT staff.
The new location opened on time. The manufacturing software was configured, installed and loaded in less than 5 weeks. With the rapid training and intuitive solution, the entire plant was operational and running at the opening.
“CIMx helped us create a world-class paperless facility”
A medical device manufacturer struggled to meet 21 CFR Part 11 regulations with paper-driven production processes. Mistakes in data collection and disparate manufacturing databases led to discrepancies and errors in production records. The error-prone paper-driven processes hindered production and led to costly quality escapes and repeated failed audits. With an upcoming serious audit fast approaching and the possibility of a partial shutdown, the manufacturer turned to CIMx early in January for a solution.
The customer achieved 100% improvement in compliance records, more than 30% reduction in quality escapes, and more than 10% increase in production volume.
A manufacturing company purchased a supplier providing components to their products. Integration into their company manufacturing standards was essential for record standardization, visibility and control of production between sites. The production records required rigorous accuracy and completeness to provide traceability of all parts on all orders.
The compatible information, data and production records between sites increased efficiency across the organization. The paperless solution has eliminated quality escapes and integrated traceability records. Operation across the sites and systems is now seamless, contributing an estimated annual savings far exceeding the one-time cost of the solution.
Paperless Manufacturing reduces waste,
Quantum provides complete control and visibility of your current processes. Quantum is a single, integrated source of manufacturing data. Identify issues before they affect your bottom line.
Data Migration Engine gives you secure access to old production records. Compare, complete and even correct data you can’t access reliably today. Build current production goals with prior performance metrics.