Quality, Efficiency, Regulatory Compliance.
With comprehensive coverage ranging from Equipment Integration and Manufacturing Operations Management to Data Analysis and Manufacturing Intelligence solutions, this Productivity Suite provides a one-stop-shop integrated solution for the most demanding Medical Devices manufacturing requirements.
While having all the necessary flexibility to model a variety of manufacturing environments from the most simple to highly complex operations, cmNavigo MES provides for tight product and process control, reducing variability and increasing traceability, enabling solid regulatory compliance. In addition, this proven pre-configured edition provides the necessary toolset to easily increase efficiency, yield and throughput.
cmNavigo for Medical Device Manufacturing is the answer to implementing a scalable and agile Manufacturing Execution System, ensuring proper support for compliance to Titles 21 CFR Part 11 and 820.
Quality and Process Control
cmNavigo Productivity Suite provides a modular, yet fully integrated, approach for the most challenging requirements of product life-cycle management, process control and quality improvement, going well beyond the traditional MES systems, encompassing Automation, Execution, Control, Engineering and Quality functions.
Advanced Statistical Process Control
Online Statistical Process Control (SPC) with variable & attribute charts, Western Electric and user defined rules. A Holistic concept integrating Data Collection, Exceptions, Resource and Material Tracking: data automatically collected from the equipment, processed (calculation), posted into EDC, fed into SPC control charts (or just having limits simply verified without SPC) and trigger quality protocols with automatic actions such as hold lot or equipment and notify responsible persons.
Advanced Data Collection
Advanced data collection, with flexible limits, dynamic samples, readings, groupings and calculations. Manual, Automated or Mixed, as well as Immediate or Long-Running data collections. Fully integrated with Statistical Process Control (SPC) and Exception Management.
Maintenance Management and Calibration
Ad-hoc (on-demand), time and usage based equipment maintenance management integrated with Material and Resource management. Outlook calendar-like maintenance plans allow easy and interactive management of maintenance plans, including bill-of-parts and checklists per maintenance activity and spare parts inventory management, calibration procedures including specific directions and limits for accuracy and precision. Records include equipment, operator, calibration date, next calibration date and other user defined fields.
Electronic Failure Catalogue
Associating failure types with images and failing / acceptance criteria allows automatically generated failure catalogues. Operators access the catalogue in real-time, filtered for the operation in question, analyze criteria and pick the applicable loss code from a matching picture. Fast and interactive navigation with deep zoom capability for high-definition images.
Out of Control Action Plans (OCAPS)
Advanced OCAPS or Quality protocols, based on user defined workflows, are used to model analysis, containment, corrective and preventive product or process actions. Protocols are automatically triggered by equipment, SPC rules, EDC limits or any MES action, or by manual operator decision. Each protocol includes mandatory or optional sequential or non-sequential step, assigned to different organizational role. Each step has user defined fields, checklist and MES automatic or manual actions.
Factory modeling and Master data management, including change control of versioned objects and approval roles. It includes a wide range of change management functions, including Create Change Set, Approve, Reject, Terminate, Set Effective, Rework and Make Effective.
The demanding regulations of the medical devices segment must not translate into a less efficient and therefore less profitable operation, based on paper records or lengthy and redundant manual processes. It is essential that a modern MES combine regulatory compliance with increased throughputs and resource utilization. The cmNavigo holistic approach provides the necessary tools to drive up manufacturing efficiency.
Efficient Material Tracking Operations for every purpose
cmNavigo for Medical Devices manufacturing provides the most complete industry set of WIP transactions, designed for low effort and high performance operations of complex material structures and containers, including Assemble / Disassemble (Manual or Automatic), Attach / Detach, Combine, Expand / Collapse, Associate / Disassociate, Grade, Replace, Transfer, Empty, Split-by-product beyond all the classical WIP transactions.
It is extremely easy to design and deploy a factory layout and then monitor the facilities, areas and equipment status in real time, including automatic e-mail or text message notifications. Get an immediate overview of the status of production lines and quickly zoom into the problem areas to find all manufacturing details through history, chart or report widgets associated with the entities being analyzed.
Instantly and graphically visualize and navigate through end-user defined and configured dashboards with material, resource or any other user defined query, with online information, in chart, report, table or graphical interactive modes.
Advanced Reports, Analytics and Business Intelligence
A full set of Industrial engineering reports, including OEE, PPH, Cycle-time, Yield, Uptime, is provided out of the box. Existing reports can be modified and new reports can be created and published on-the-fly. An included Data Warehouse is pre-configured with several data aggregations enabling interactive data slicing and dicing operations. Advanced data mining algorithms are available for in-depth analysis, including time series, decision trees and neural networks. Costs are associated with materials, equipment and labor providing accumulated values for WIP at any stage of the process.
Flexible ERP integration for production orders, inventory status updates, master data and maintenance operation data exchange. Synchronous or Asynchronous calls with buffering in the event the ERP is not available.
The built-in security, a fully accessible history of any record change, a highly flexible set of modeling possibilities and a comprehensive set of integrated quality modules allows regulatory compliance, ensuring proper support for compliance of FDA’s Title 21 CFR Parts 11 and 820.
Electronic Signatures and Records
The cmNavigo MES supports the FDA’s Title 21 CFR Part 11 regulations for electronic signatures, equivalent to handwritten signatures executed on paper and trustworthy and reliable electronic records and audit trails, equivalent to paper records.
An innovative hierarchical model allows straightforward setup of hierarchical material structures allowing high-performance multi-level tracking, in single or clustered equipment, across hierarchical flows, maintaining all sub-material traceability and high-level material integrity. Data collections can be performed at any level: batch, lot, sub-lot or even at unit ID or serial number level.
Multi-level security options allow different configurations for visibility or execution permissions at the graphical user interface, API and object level, ensuring control and protection for the most challenging security compliance requirements.
Operator Training and Certification
Easily configured manufacturing roles, allow the definition of the necessary trainings and certifications, including scope and expiration, and validate the execution for each shop-floor function.
Avoid Human Errors through Automation
cmNavigo’s integrated equipment connection platform, allows full automation. With advanced point & click configuration and service and message mapping, the system supports multiple communication protocols. Advanced data collection and recipe management modules eliminate errors in both recipe selection and data collection.
Interactively design, preview and print labels, dynamically generated with context driven information for text, images or barcodes, attached to the corresponding material units, supporting CFR Title 21 part 820 labeling requirements.
For a functional overview of cmNavigo, please
MES allows Medical Device Manufacturer to increase Compliance, Efficiency and Control
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FDA CFR 21 Part 11
For information on cmNavigo MES compliance towards FDA CFR Title 21 Parts 11 and 820
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For more information about cmNavigo, please download the product brochure
cmNavigo brochure 3.01MB
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