Design Controls

Connect every user need, requirement, design output, and verification record in a unified, audit-ready product thread from initial concept to commercial launch.

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Regulatory Scrutiny Demands a Complete, Connected Design Record
What are Design Controls in Manufacturing?
Design controls are the disciplined processes and documented evidence that govern how a product is conceived, developed, verified, and validated to meet user needs and regulatory requirements. Propel threads design controls across the full product lifecycle, so modern manufacturers keep every design decision traceable, defensible, and audit-ready.
Capturing Needs & Requirements
Structured capture of User Needs and Product Requirements, tied directly to the BOM from day one, prevents missed or poorly documented requirements from derailing submissions and triggering costly rework downstream.
Controlled Design Changes
Rigorous change control processes ensure that design evolution is deliberate, that impacted records are updated in lockstep, and that the complete change history is available on demand.
Audit-Ready Design Records
When design records live on a unified product thread rather than in siloed file systems, teams can respond to regulatory inquiries and internal audits in minutes rather than weeks.

Propel Closes the Loop Across Every Design Control

End-to-End Traceability
Propel's Product Requirements link User Needs, Requirements, Design Outputs, and Verification and Validation Test Plans directly to Items and BOMs at any level. The auto-generated Trace Matrix captures the full evidence chain and exports to CSV for submission-ready documentation.
Controlled Change at Scale
Configurable, criteria-based approval workflows route Engineering Change Orders through the right approvers, lock affected Items by revision and lifecycle, and maintain a complete audit history.
Unified Medical Device File Records
Propel unifies Design History Files and Device Master Record management with revision-controlled documents, electronic signatures compliant with 21 CFR Part 11, and full document traceability, giving regulated manufacturers a single source of truth for every design record.
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More Capabilities
Trace Matrix
Requirement Reusability
Electronic Records and Signatures
Training Management
Product Registration
Trace Matrix
Auto-generates and stores a traceability matrix linking Items, User Needs, Requirements, and Test Plans. Supports CSV export and roll-up of requirement data through BOM levels for audit- and submission-ready evidence packages.
Requirement Reusability
User Needs and Requirements can be reused across multiple products and product lines, with direct BOM linkages so requirement fulfillment is traceable from concept through production. Reduces redundant documentation work and promotes design consistency across portfolios.
Electronic Records and Signatures
Configurable e-signature workflows comply with FDA 21 CFR Part 11, with automatic logoff and controlled access settings. Every approval, review, and release is captured with a tamper-evident audit trail tied directly to the affected design record.
Training Management
Manages employee certification against the latest released product revisions and processes. Training plans, quizzes, and sign-off records are logged in a complete audit trail, ensuring design-control procedures are understood and documented across the team.
Product Registration
Plans, tracks, and renews global product registrations tied to design and regulatory submissions. Registration records connect directly to the design data they reference, giving regulatory affairs teams a single place to manage submission status across all markets.
Concept To Customer Solutions for Fast-Moving Product Companies
Propel PLM
Cloud-native, role-based, and easy-to-use product lifecycle management enables enterprise-wide collaboration so teams work smarter, faster, and better together.
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Propel QMS
Complete quality management system that unifies part, process, and supplier quality to deliver safer products, higher customer satisfaction, and increased profits.
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Propel One
Natively integrated agentic AI automates workflows, surfaces insights, and accelerates every team across PLM, QMS, and PIM from concept to customer.
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Imperative Care Cut Management Review Time from 5 Days to 5 Minutes
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Accelerated review cycles
Imperative Care needed design and quality reviews to move at the pace of their product development. After adopting Propel, management review cycles that once consumed five days were compressed to five minutes, accelerating the entire design control workflow without sacrificing rigor or traceability.
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FAQ
How does Propel support 21 CFR Part 820 and the new FDA QMSR requirements?
Propel's QMS manages Medical Device File, Design History Files, Device Master Records, and all associated design-control documentation with full revision control and 21 CFR Part 11-compliant electronic signatures. The FDA QMSR final rule, effective February 2, 2026, consolidates legacy DHF, DMR, and DHR requirements into the Medical Device File aligned with ISO 13485:2016. Propel's unified product thread is structured to meet both frameworks without requiring separate systems. Explore Propel QMS.
Can Propel connect requirements traceability directly into our product BOM?
Yes. Propel's product requirements allows teams to link User Needs and Requirements directly to specific BOM Items at any level, so traceability runs from original user intent through design outputs and into verification records. The Trace Matrix auto-generates this evidence chain and can be exported for regulatory submissions or internal audits.
How does Propel handle design changes without breaking compliance records?
Change Orders in Propel route through configurable, criteria-based approval workflows that lock affected Item revisions and lifecycle. Every revision to an Item, BOM, attachment, or quality record is captured in a human-readable audit history.

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