QMS

Propel QMS is a cloud-native, AI-powered electronic quality management system (eQMS) designed for life sciences and product companies that need to connect quality processes across engineering, suppliers, and service operations. It manages the full range of quality and compliance activities — from document control and change management to CAPA, audits, and supplier quality — on a single platform, linking quality data directly to the complete product record throughout the product lifecycle.

Propel QMS is built for organizations seeking to reduce quality-related costs, mitigate compliance risk, and accelerate issue resolution. Reported outcomes from users include 25% faster issue resolution, 50% less document control effort, 60% faster training timelines, and a 100% audit pass rate.

AI-Powered Quality Capabilities

• AI-assisted CAPA, SCAR, and NCR processes to accelerate core quality functions from initiation to closure.
• Native AI that interrogates complex documentation and provides instant answers to compliance questions.
• Automatic generation of training quizzes from documents and standard operating procedures (SOPs).

Product Quality Management

• BOM Management: Compare revisions, visualize redlines, and manage multiple work streams with a bill of materials available in hierarchical or tabled structures, including BOM items, item revisions, recently viewed items, and affected items.
• Complaints: Configurable complaint management workflows with decision trees that automatically determine global regulatory reporting requirements to reduce errors and non-compliance.
• CAPA: Corrective and preventive action processes for collecting and analyzing information, investigating product issues, and executing remedial actions, with automation to support efficient resolution.
• NCMR: Non-conforming material reports that record non-conforming material and supplier information, integrating with CAPA and audit processes to support FDA and ISO compliance.
• Equipment and Calibration: Tracks and manages equipment calibration and maintenance status, allowing equipment to be marked active or inactive based on results.
• First Article Inspection: Evaluates manufactured parts against design specifications, captures inspection results and sample sizes for traceability, and automatically triggers NCMRs on failed inspections.
• Part Master: Centralizes all item information — including descriptions, revisions, BOMs, manufacturer part numbers, manufacturing cost, Where-Used, and related items — in a single record.

Compliance and Document Control

• Document Management: Maintains product and process documents with secure access, revision tracking, and approval workflows to keep records audit-ready and compliant.
• Document Traceability: Tracks all document relationships and dependencies from any record, supporting compliance with ISO 9001:2015 and ISO 13485:2016.
• Change Control: Configurable change order workflows and approval processes with interactive dashboards to track open change orders and approver progress.
• Training Management: Manages employee certification on the latest product versions and processes, with document-based training programs and analytics to support audit readiness.
• Audits: Automates audit processes from planning through reporting, with templates for organizing and distributing records to internal and external parties.
• Product Registration: Plans, monitors, and tracks global product registrations and licensing across all countries where products are sold, including expiration tracking and renewal management.

MedTech-Specific Compliance Features

• Design History Files (DHF): Supports 510(k) clearance and premarket approvals by maintaining DHFs that meet 21 CFR 820 requirements, accessible on demand.
• Device Master Records (DMR): Maintains compliance with 21 CFR Part 820 through controlled DMR document practices with tracked revisions and retained change history.
• Electronic Records and Signatures: Supports FDA 21 CFR Part 11 compliance with configurable controls over electronic records, signatures, user security, automatic logoff, and audit features.
• MedWatch FDA eSubmissions: Simplifies compliance with FDA 21 CFR Part 803 by syncing complaint data into the MedWatch 3500A Form and triggering electronic submissions to FDA ESG with full audit traceability.
• eIFU: Supports electronic instructions for use (eIFU) compliance with EU and FDA regulations, including MEDDEV 2.14/3 and MDR Regulation (EU) 2017/745, rendering valid IFU revisions based on region, country, and language.

Supplier Quality Management

• Supplier Qualification: Periodically re-evaluates suppliers against compliance, quality, delivery, risk, and environmental governance criteria, with the ability to remove underperforming suppliers or components from the AVL/AML.
• SCAR: Initiates supplier corrective action requests for product non-conformities through secure, controlled collaboration workflows with suppliers.
• Supplier Collaboration: Provides role-based access for authenticated suppliers at multiple levels — including product, BOM, component, AML, and lifecycle — to protect intellectual property while enabling collaboration.
• Supplier Rating: Tracks and rates supplier performance across recalls, complaints, change management, materials management, product cost, shipping cost, and target price achievement.

Propel QMS is deployed as a cloud-native platform, supporting enterprise-wide collaboration by connecting quality, engineering, and service operations through a single, continuous product record. The platform is designed to integrate quality and compliance processes during the design phase as well as throughout the supply chain, and has been adopted by medical device and other regulated product companies. Customer Breg, for example, consolidated over 20 legacy systems into Propel, reporting up to 77% faster time to market and 67% less time to onboard engineers.