Regulated Hardware. Precise Records.
Hardware traceability for devices that touch lives.
Medical device and biotech hardware demands an unbroken chain of documentation. Boltline gives you audit-ready lot tracking, supplier qualification, and FDA-compatible records — without the compliance overhead.
Part 11-aligned records
Lot traceability to device
QMS-compatible workflows
DHF hardware section export
The Problem
BioTech teams face unique hardware challenges.
Device History Records
Every fastener in a regulated device assembly needs a complete history from incoming inspection to final build. Boltline handles that automatically.
Supplier Qualification
Approved supplier lists with expiry tracking, audit records, and incoming quality inspection data in one place.
Lot Traceability
Maintain forward and backward traceability across every production lot — essential for recalls and CAPA investigations.
Change Control
Engineering change orders that route for approval before touching a released BOM, with full signature history.
Purpose-Built Features
Boltline for BioTech
Auto-generate DHR hardware sections from BOM + receipt + inspection data — no manual assembly.
Instantly identify every device that contains a specific lot, or every lot in a specific device.
Log inspection results against lot records with pass/fail criteria and user signatures.
Structured engineering change orders with review routing before any BOM modification is committed.
Approved vendor list with certification expiry alerts and incoming quality performance history.
Trace affected hardware across production runs in minutes to support corrective action investigations.
Standards & Compliance
Boltline is designed to support your documentation and audit requirements across these frameworks.
Our FDA audit went smoothly for the first time ever. Every hardware record they asked for was a two-second lookup.
Ready to bring order to your hardware?
See how Boltline works for biotech teams — no spreadsheets required.