CIMx Software is experienced in providing proven solutions to regulated manufacturing companies.  CIMx’ Interax product is the most secure system available for creating, maintaining and archiving interactive data required by regulated agencies.  It meets all 21 CFR Part 11 requirements for electronic records.  

The advantages of Interax in FDA regulated manufacturing are:

•   Electronic validation and compliance with FDA 21 CFR Part 11         
•   Ability to meet FDA requirements faster with less effort and cost
•   Secure, error-free management of GxP records and signatures

•   Automatic generation of Batch Processing Records (BPR)
•   Automatic collection of complete, accurate lab test results
•   Elimination of paper forms
•   Real time processing records, discrepancy reports and safety profiles
•   Real time CAPA information 
•  Elimination of errors (wrong data, transcription errors, other)

•  Procedural enforcement of process to assure consistency
•  Consistent, complete change control process
•   Non-compliance control and documentation                                             
•   Secure electronic signature capability

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 that are collected support audits and traceability.

Our Experience

All regulated manufacturing companies have common characteristics and requirements.  The FAA regulation of aerospace companies, the DOD monitoring of defense companies and the FDA regulation of life sciences companies all have a common foundation.  They all require the following:

• secure records that cannot be manipulated or changed
• complete, accurate production documentation
• complete, accurate quality testing data management
• accurate process instructions
• accurate change control processes
• non-compliance management and traceability
• complete audit capabilities when required

These requirements define the core capabilities of the Interax solution that supports and manages the manufacturing process in many regulated companies.