FDA REGULATED SOLUTIONS

FDA REGULATED COMPANIES


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.

100% Traceability on All Products

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..

FDA REGULATED INDUSTRIES

TRACK THE LIFECYCLE OF SERIALIZED PARTS


FDA REGULATED
UDI Tracking
The US FDA (Food and Drug Administration) requires a UDI (Unique Device Identification) for medical devices.  The system helps identify products after distribution and use. Quantum ensures you comply with these regulations with process enforcement and comprehensive production management.
 
The UDI is a unique numeric or alphanumeric code consisting of two parts – the Device Identifier (DI), which identifies the specific model of the device, and the Production Identifier (PI) that identifies specific details related to the manufacturing of a device.
 
Control engineering changes Ability to meet FDA requirements faster with less effort and cost
 
Automatic generation of Batch Processing Records (BPR)
 
Automatic collection of complete, accurate lab test results
 
 
Stay On Schedule
A finite scheduler in Quantum ensures you meet scheduled ship dates through the complex medical device manufacturing process. Identify potential problems early, and re-route work as needed without sacrificing quality or stringent regulations or traceability requirements.
 
When combined with the Global Unique Device Identification Database (GUDID), the FDA will be able to identify problems with a device and track defects to more effectively issue recalls. 
 
Complete and accurate device assembly records with specifications validated Elimination of paper forms
 
Real time processing records, discrepancy reports and safety profiles
 
Real time CAPA information
 
Elimination of errors (wrong data, transcription errors, and others)
 
Procedural enforcement of process to ensure consistency
 
 
Accurate Data Collection
Fulfilling the UDI requirements means real-time data collection, accurate archiving of manufacturing data, and shop floor control – standard functionality with the intuitive manufacturing software found in Quantum. Automate tasks so eliminate non-value added time in production
 
These regulations require medical device companies accurately collect manufacturing data.  Fulfilling the UDI requirements means real-time data collection, accurate archiving of manufacturing data, and shop floor control – all benefits of MES and Paperless Manufacturing.
 
Consistent, complete change control process and records
 
Non-compliance management, control and documentation
 
Secure, error-free management of GxP records and signatures
 
Secure electronic signature capability
 
 

"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..."

American Manufacturing Experience

MANUFACTURING SOFTWARE WITH EXPERIENCE IN YOUR FIELD

For 20+ years, CIMx Software has been a part of the manufacturing fabric of America. Our customers will tell you, CIMx Manufacturing Solutions changed how they viewed their shop floor.
PAPERLESS MANUFACTURING

SMART MANUFACTURING SOLUTIONS

tailored to your unique needs

From the shop floor to the executive suite, let us personalize a package that bridges the gaps in your current system.

 

Find Your Solution

QUANTUM ENTERPRISE MES

QUANTUM ENTERPRISE MES

the complete manufacturing experience

Close the production loop at a single location or across the entire enterprise while providing the foundation for Smart Manufacturing with Quantum MES.

 

Schedule a Demo

DATA MIGRATION ENGINE

DATA MIGRATION ENGINE

providing a bridge to your future

Revive lost resources, transition old databases, retire depricated servers & access critical data anywhere.

 

 

Revive Your Data

Interested? Keep scrolling to learn more about going paperless.

REQUEST A DEMO

TRACK YOUR PRODUCTION ANYWHERE

PAPERLESS ERP SOLUTIONS

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.

SUCCESS STORIES
Military Success

Military Equiptment Manufacturer

Defense Industry

STORY

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.

RESULTS

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
-Product Manager

read the full story here

Medical Device Success

Medical Device Manufacturer

Medical Industry

STORY

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.


RESULTS

The customer achieved 100% improvement in compliance records, more than 30% reduction in quality escapes, and more than 10% increase in production volume.

read the full story here

Discrete Manufacturer Success

Discrete Manufacturer

Manufacturing Industry

STORY

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.


RESULTS

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.

 

  

read the full story here

INTEREST PIQUED? CHECK OUT OUR BLOG

Manufacturing Blog
Whether you're interested in Paperless Manufacturing or just manufacturing with less paper, we have your corner of the market covered. Become an expert in the field by reading up on Paperless Manufacturing at our CIMx Manufacturing Blog. We have hundreds of posts covering a vast spectrum of topics. 

BLOG RECOMMENDATIONS FOR FDA REGULATED COMPANIES

 
 
 
 
 
 

THE SOLUTION YOU'VE BEEN WAITING FOR

Quantum Paperless Manufacturing
PAPERLESS MANUFACTURING
Paperless Manufacturing reduces waste, errors and costs on the shop floor by identifying issues early and providing immediate workflows to solve these problems. 
 
QUANTUM MES
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
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. 
Paperless Solution Suites

PAPERLESS MANUFACTURING

Optimize Your Operations

Paperless Manufacturing reduces waste, errors and costs on the shop floor by identifying issues early and providing immediate workflows to solve these problems.

Quantum MES

QUANTUM MES

The Complete Manufacturing Experience

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 Services

DATA MIGRATION

Building a Bridge to Your Future

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.

Contact CIMx Today