CMPRO Medical Device Edition PLM Software
Facilitate Medical Device Compliance with CMPRO MD Edition PLM Software
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Preventive Processes with Dashboard Oversight
Reduce corrective actions by streamlining and reinforcing preventive processes, monitor using dashboards with detailed, drill-down capability.
Organize devices by product and model, using logical data groupings to manage key artifacts according to their purpose and reporting requirements.
Process Workflow Engine
Powerful routing engine automates organizational processes through electronic forms, enabling collaboration and real-time metrics. Includes pre-configured workflows optimized for core processes. Satisfies FDA requirements for CFR 21, Part 11, Electronic Records, Electronic Signatures.
Projects, Tasks and workflow-enabled Action Items link to other forms and records used for artifact and process management. Coordinate the work needed to design, build and support devices.
Revision controls and visibility permissions add accountability and oversight to key device artifact data and files, all from centralized repositories.
Drawings & Parts Lists
Manage information about device assemblies and their components, including Bills of Material. Used to generate Device Master Record data. Link to document and software data.
Managed by type with next-higher relationships connecting documents that go together hierarchically. Link to drawing, part and software data.
Manage released software and software licenses. Link to drawing, part and document data.
Medical Device Compliance
QMS – Quality Management System
Artifact management and process automation functionality complies with 21 CFR, Part 820, Quality System Regulation. Create and maintain centrally controlled quality plans, policies and procedures transparently, in the form of linked document artifacts. Details specified in the linked document artifacts can translate into action using workflow-enabled forms to automate processes. The result is a closed-loop quality management system.
DHF – Design History File
System Baseline functionality creates multiple point-in-time snapshots of device design artifact data, current and in-work, to facilitate demonstrating a design was, or is currently, being developed in accordance with approved design plans and requirements, per 21 CFR, Part 820.30 Design Controls.
DMR – Device Master Record
Product Baseline functionality can create published, point-in- time part-structure-based snapshots from device design data that specify the aspects of how a device is to be manufactured in accordance with 21 CFR, Part 820.181 Device Master Record; 21 CFR, Part 820.40 Document Management.
DHR – Device History Record
As-Built functionality captures the manufacturing details for a device and the artifacts generated during its production, testing, review and inspection. This data satisfies 21 CFR, Part 820.184, Device History Record.
CAPA – Corrective and Preventive Action
Workflow-enabled forms, including a CAPA-specific form, link to other device data in CMPRO, giving complete, real-time status of preventive actions, problem reports, change notices and requests, non-conformances and more. Satisfies 21 CFR, Part 802.100 Medical Device Reporting.
Baseline: Artifact Data Snapshots for Compliance
CMPRO uses different types of baseline functionality to create point-in-time snapshots of device artifact data that may be referenced for a variety of purposes, including
Snapshot of current or in-work artifacts for devices, many of which are design-oriented. This type of baseline is sometimes referred to as a Technical Data Package. In the context of a Design History File used to facilitate device compliance, each System Baseline may contain, or be linked to, the artifacts necessary to demonstrate the device’s design was, or is currently, being developed in accordance with approved design plans and requirements.
Snapshot of part-structure data, together with the artifacts used to design, describe and approve the parts in the structure, including a traditional Bill of Materials. In the context of a Device Master Record used to facilitate device compliance, each Product Baseline may include, or be linked to:
- Device specification artifacts, such as drawings, compositions, formulations and component & software specifications.
Device production process artifacts for equipment, production methods, production procedures and production environment.
- Device quality assurance procedure and specification artifacts, including acceptance criteria and equipment to be used.
- Device packaging and labeling artifacts for methods, processes used, installation, maintenance and servicing procedures.
Snapshot of a document hierarchy. Such hierarchical structures are critical for managing the plans, policies and procedures used to ensure the quality of a device.
Snapshot of a released software hierarchy, including software versions, that usually relate to medical device hardware and may reference software license tracking data.
As-Built functionality tracks manufactured devices and may include or refer to the location of the following for each device:
- Dates of manufacture.
- Quantity manufactured.
- Quantity released for distribution.
- Acceptance records that provide evidence a device was manufactured in accordance with its Device Master Record.
- Primary identification label and labeling used for each production unit of the device.
- Device identification and control numbers used, including the unique device identifier and universal product code.