Propel is the only quality management system (QMS) that engages the entire value chain to improve quality throughout the product lifecycle. Propel eQMS reduces expense, mitigates risk, and drives top-line growth.
Better quality. Safer products. Higher profits.
Propel QMS extends quality and compliance processes to suppliers, engineering, and service teams on a single platform – improving product quality before production begins, and accelerating remediation when field issues are discovered.
Propel's QMS system enables automated workflows and seamless collaboration across a full suite of product quality processes to deliver better products and higher profits.
Compare revisions, visualize redlines, and retain multiple work streams with a user-friendly bill of materials (BOM). BOM items, item revisions, recently viewed, and affected Items are available in a hierarchical or tabled BOM structure.
Ensure efficient complaint management with fully configurable workflows to meet your specific needs. Reduce the risk of errors and non-compliance by incorporating decision trees that automatically determine global regulatory reporting requirements.
Corrective and preventive action (CAPA) processes allow users to collect and analyze information, identify and investigate product issues, and take appropriate remedial actions. Automation and connectivity ensure quick and efficient issue resolution.
Record non-conforming material and related supplier information in non-conforming material reports (NCMR). Integrate with other quality processes such as CAPA & audits to disposition and resolve non-conformances and comply with FDA & ISO regulations.
Ensure assets and equipment are properly calibrated and maintained to keep employees safe and reduce manufacturing costs. Manage equipment and mark it as active or inactive based on its calibration and maintenance results.
Evaluate manufactured parts and establish clear acceptance criteria according to design specifications. Capture inspection results and sample sizes for complete traceability – and trigger automatic NCMRs on failed FAIs.
Find all item information under one record, including descriptions, revisions, BOMs, manufacturer part numbers (MPN), manufacturing cost, Where-Used, and related items. A single source of truth for informed decisions and to manage item master records.
Ensure product and process documents are always up-to-date and audit-ready with secure access, revisions, and approval workflows in one trusted source to improve productivity while mitigating risk.
Traceability and easy-to-manage workflows keep product development on track while maintaining compliance with ISO 9001:2015 and ISO 13485:2016 requirements. Easily see all document relationships and dependencies from any record.
Configurable change order workflows and approval processes ensure product changes are made as quickly as possible without missing any approvers. Interactive dashboards track open change orders to ensure approvers are making progress.
Ensure regulatory compliance by managing employee certification on the latest product versions and processes. Improve employee safety and confidently pass audits with document-based training programs and analytics.
Streamline and automate audit processes from planning to reporting. Templates make key record organization and distribution to internal and external parties a breeze.
Accurately plan, monitor, and track global product registrations and licensing in all countries where products are sold. Streamline registration creation and renewal processes – including tracking expirations – to ensure that deliverables are completed on time.
Drive successful 510(k) clearance and premarket approvals with Design History Files (DHF) that meet 21 CFR 820 requirements. Access to product DHF is easy and can be viewed on demand.
Maintain compliance with 21 CFR Part 820 and other regulations with Device Master Records (DMR) document practices. DMRs can be configured as a controlled document where each approved revision is tracked and change history is retained for audits.
Comply with FDA 21 CFR Part 11 requirements ensuring full control over electronic records and electronic signatures. Configure Standard Operating Procedures (SOPs) across user security, automatic logoff, controlled access, and audit features.
Simplify compliance to FDA 21 CFR Part 803 Medical Device Reporting using Propel’s Digital FDA Submissions. Sync related Complaint data into MedWatch 3500A Form and automatically trigger electronic eSubmissions to FDA ESG with full audit traceability.
Achieve electronic instructions for use (eIFU) compliance related to EU and FDA regulations, such as MEDDEV 2.14/3 and MDR Regulation (EU) 2017/745. Criteria such as region, country, and language render only the valid list of IFU revision(s).
Periodically re-evaluate partners to ensure they meet compliance and company objectives for product capabilities, quality, delivery performance, risk, and environmental governance. Remove poor-performing suppliers and/or components from the AVL/AML.
Initiate supplier corrective action requests (SCAR) for product non-conformities. Collaborate directly with suppliers using SCAR workflows in a secure and controlled manner.
Safeguard intellectual property with secure collaboration between original equipment manufacturers (OEMs) and authenticated suppliers. Configure role-based access for each supplier at multiple levels, such as product, BOM, component, AML, and lifecycle.
Rate supplier quality across multiple measures, including recalls, complaints, change, materials management, and more. Track and manage supplier performance for product cost, shipping cost, and ability to reach target price.
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