ERP for Medical Device Manufacturers Built for Auditable Operations
When an FDA auditor or a notified body asks for a lot history, the answer needs to be immediate and complete, not "give us a few days to pull the records together." Axolt connects quality, traceability and production so the record you show an auditor is the same record your team already runs the business on.
Material Receipt & Inspection
Incoming components and supplier lots checked against approved vendor records
Lot / UDI Assignment
Genealogy established from raw material through work in progress
Production & Quality Hold
Failed inspections stop the affected lot from shipping automatically
DHR/DMR Release & Shipment
Device history built from the same data that ran production
A quality process that isn't connected to production isn't really a quality process. It's paperwork that catches up after the fact, and it's the first thing an auditor learns to distrust. Axolt runs device traceability, quality holds and documentation directly inside Salesforce, connected to the same production and inventory data your operations team already works from.
The Compliance Gap
Why Audit Requests Become Fire Drills
When Quality Isn't Connected to Production
Medical device manufacturers need more than efficient production. They need a single, connected record across quality, traceability, production and inventory.
Who This Is Built For
Medical device manufacturers and contract manufacturers already running or evaluating Salesforce, typically ISO 13485 certified or pursuing certification, managing UDI compliance, and currently running quality, inventory and production as separate, disconnected systems.
Signs You've Outgrown What You Have
- A lot traceability request during an audit takes longer than it should because the data lives in more than one place
- Quality holds are tracked manually, with real risk a held lot could ship if someone forgets to flag it everywhere
- Your DHR/DMR process means compiling records from production, quality and inventory separately
- CAPA investigations take longer than they should due to cross-referencing disconnected systems
- You're scaling toward a new regulatory submission and know your current systems won't hold up under scrutiny
Axolt runs device traceability, quality holds and documentation directly inside Salesforce, connected to the same production and inventory data your operations team works from every day, so the record an auditor asks for is the same record your team already uses to run the business.
Built For Regulated Device Manufacturing
Everything Medical Device ERP Needs
UDI and Lot/Serial Traceability
Full genealogy from raw material through finished device to shipment, queryable in real time, not reconstructed after an audit request lands on your desk.
Quality Holds Tied Directly to Production
A failed inspection stops the affected lot from shipping automatically, rather than relying on someone remembering to flag it across systems.
DHR/DMR-Ready Documentation
Device history and master records built from the same data that runs production, not a parallel manual record-keeping process someone maintains on the side.
CAPA and Non-Conformance Management
Corrective and preventive actions tracked against the specific lot, supplier and process step involved, with a clear audit trail of what changed and why.
Supplier Quality for Approved Vendor Lists
Incoming inspection and supplier scorecards connected directly to the components they supply into your devices, so a supplier's quality trend is visible before it becomes a recall.
Why This Matters on Salesforce
Regulatory and quality teams need answers fast during an audit or a field issue. "Show me everything about this lot" shouldn't mean opening four applications and hoping the timestamps line up. Because Axolt's quality, inventory and production data live in the same Salesforce org, that query is one search, not an afternoon of cross-referencing spreadsheets under audit pressure.
Common Questions
What Device Manufacturers Ask
Before Switching
Is Axolt validated for FDA 21 CFR Part 11?
This is a specific compliance claim that needs to come directly from Axolt's regulatory documentation, not inferred from general capability. Confirm current validation status with Axolt directly before relying on it for a submission.
Does this replace our existing QMS?
Axolt connects quality processes, holds, CAPA and non-conformance, to live production and inventory data. Whether it replaces a standalone QMS or works alongside one depends on your current QMS's scope, worth a specific conversation about your setup.
How does this handle multi-site device manufacturing?
Axolt supports multi-location inventory and production with traceability maintained per site and rolled up for enterprise-level audit visibility.
Ready for Audit-Ready Device Manufacturing?
Quality. Traceability. Production.
One Auditable Record.
Bring device traceability, quality holds, CAPA and DHR/DMR documentation together with Axolt Medical Device ERP on Salesforce.