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an Emerson Process Management group company  

PAPERLESS SOLUTIONS FOR cGMP MANUFACTURING

Compliance Suite applications deliver integrated, efficient, cost-effective solutions for:

  • Document control
  • Process execution
  • Information management
  • Data delivery in support of FDA-regulated industries.

Compliance Suite consists of component applications that can be used individually or bundled for maximum productivity:   

Security and Audit (SA)   
Security and Audit represents a powerful solution for addressing security and 21 CFR Part 11 concerns for electronic records and signatures. In addition, SA provides comprehensive audit trail services of all production and operations activities for all members of the Compliance Suite applications.
Portal   
Portal is a completely configurable workspace that provides unparalleled insight into a companies operations, providing performance metrics, graphs and charts, and information about the Compliance Suite modules and other third-party applications.
Document Control and Archiving (DCA)   
Document Control & Archiving is a content repository that provides controlled access to manufacturing documentation. Manufacturers maintain full control of their documents and version information, while meeting 21 CFR Part 11 compliance requirements. DCA allows electronic review and approval.
Training and Development (TD)   
Training & Development supplies records management and tracking of cGMP training courses, administration, and personnel scheduling. Enables other DMI Compliance Suite applications to check operator qualification for specific tasks.
Equipment Tracking (ET)   
Equipment Tracking documents equipment properties and states in addition to definable equipment events like usage, cleaning, and maintenance in any manufacturing environment. The system provides paperless calibration records and equipment logbooks with real-time updating using RF handheld devices.
Recipe Authoring (RA)   
RA simplifies and speeds the process of generating documents such as batch records, test methods, validation protocols, and other documents amenable to a modular approach
Materials Management (MM)   
Materials Management provides centralized warehouse management capabilities with container level tracking, material geneaology, and QC controls.
Weigh and Dispense (WD)   
Weigh & Dispense offers a thin-client, radio frequency-enabled solution to the complexity of pharmacy operations. Full support for weigh scale integration and bar code printing are included in the application.
Electronic Batch Records (EBR)   
Electronic Batch Records provide paperless manufacturing records for cGMP facilities with complete product genealogy and process control.
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