CMPRO for Medical Device Development Facilitate Quality and Compliance

Process Automation with Dashboard Oversight

Automate internal and external processes to facilitate quality and compliance. Dashboards with drill-down capability provide oversight from concept to final product retirement.

Process Workflow Engine
Electronic forms streamline quality systems and preventive processes to enable cross-functional team collaboration and real-time metrics. Satisfies CFR 21, Part 11, Electronic Records, Electronic Signatures.

Project Tracker
Workflow-enabled action items and tasks coordinate projects from discovery to post-market surveillance.

Device Tracking
As-built functionality tracks manufactured devices and includes or refers to the information needed for mass manufacture, including: date of manufacture, quantity manufactured, quality released for distribution, acceptance records for DMR, labeling, unique device identifier and universal product code.

Artifact Management

Centralized repositories hold key device data and attached files. Permission-based roles, revision control and visibility permissions add accountability and oversight for QMS, CAPA, DHF, DMR and DHR data.

Drawings & Parts Lists
Manage information about device assemblies and their components, including Bills of Material. Link to document and software data. Included in DHF and DMR.

Documents
Managed by type with next-higher relationships connecting documents hierarchically. Link to drawing, part and software data. Maintains QMS baseline and included in DHF and DMR.

Software
Manage released software and software licenses. Link to drawing, part and document data. Included in DHF and DMR.

Medical Device Suite

Filter devices by model to easily view key quality and compliance data. Access and manage CAPA, QMS, DHF, DMR and DHR from the home page.

QMS – Quality Management System
Create and maintain centrally controlled quality plans, policies and procedures transparently in the form of linked document artifacts. Details specified within, can translate into action using workflow-enabled forms to automate processes. The result is a closed-loop QMS that satisfies 21 CFR, Part 820, Quality System Regulation.

DHF – Design History File
System Baseline functionality creates multiple point-in-time snapshots of current and in-work design artifact data to facilitate demonstrating that a device was, or is currently being developed according to 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 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 Controls.

DHR – Device History Record
As-Built functionality captures the manufacturing details for a device and the artifacts generated during production. 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, giving a complete real-time view and status of preventive actions, problem reports, change notices and requests, non-conformances and more. Satisfies 21 CFR, Part 820.100 Medical Device Reporting.

Process Automation with Dashboard Oversight

Automate internal and external processes to facilitate quality and compliance. Dashboards with drill-down capability provide oversight from concept to final product retirement.

Process Workflow Engine
Electronic forms streamline quality systems and preventive processes to enable cross-functional team collaboration and real-time metrics. Satisfies CFR 21, Part 11, Electronic Records, Electronic Signatures.

Project Tracker
Workflow-enabled action items and tasks coordinate projects from discovery to post-market surveillance.

Device Tracking
As-built functionality tracks manufactured devices and includes or refers to the information needed for mass manufacture, including: date of manufacture, quantity manufactured, quality released for distribution, acceptance records for DMR, labeling, unique device identifier and universal product code.

Artifact Management

Centralized repositories hold key device data and attached files. Permission-based roles, revision control and visibility permissions add accountability and oversight for QMS, CAPA, DHF, DMR and DHR data.

Drawings & Parts Lists
Manage information about device assemblies and their components, including Bills of Material. Link to document and software data. Included in DHF and DMR.

Documents
Managed by type with next-higher relationships connecting documents hierarchically. Link to drawing, part and software data. Maintains QMS baseline and included in DHF and DMR.

Software
Manage released software and software licenses. Link to drawing, part and document data. Included in DHF and DMR.

Medical Device Suite

Filter devices by model to easily view key quality and compliance data. Access and manage CAPA, QMS, DHF, DMR and DHR from the home page.

QMS – Quality Management System
Create and maintain centrally controlled quality plans, policies and procedures transparently in the form of linked document artifacts. Details specified within, can translate into action using workflow-enabled forms to automate processes. The result is a closed-loop QMS that satisfies 21 CFR, Part 820, Quality System Regulation.

DHF – Design History File
System Baseline functionality creates multiple point-in-time snapshots of current and in-work design artifact data to facilitate demonstrating that a device was, or is currently being developed according to 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 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 Controls.

DHR – Device History Record
As-Built functionality captures the manufacturing details for a device and the artifacts generated during production. 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, giving a complete real-time view and status of preventive actions, problem reports, change notices and requests, non-conformances and more. Satisfies 21 CFR, Part 820.100 Medical Device Reporting.

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Let the experts at PSA Inc. work with your organization to implement the best solution to manage quality and compliance data!

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