5
QMS modules in one platform
Document Control, Training, CAPA, Inspections, and Calibration
Quality Management System
Native NetSuite Quality Management System covering document control, training records, CAPA, inspections, and calibration - all 21 CFR Part 11 compliant with full audit trails and e-signature support.
Auto
CAPA and training assignment
Generated and assigned automatically based on triggers and priority
Full
Audit trail on all records
Every field change logged with user, timestamp, and reason
Zero
Disconnected QMS tools
All quality management runs natively inside NetSuite
Overview
End-to-end quality management inside NetSuite
Most life sciences companies run their quality management in a separate QMS tool - disconnected from the system where financial, procurement, and supply chain data lives. That means 2 audit trails to maintain, 2 systems to validate, and a manual process every time a quality event touches a financial record.
Archer QMS delivers end-to-end quality management natively inside NetSuite across 5 modules: Document Control, Training Records, CAPA, QMS Inspections, and Calibration and PM. Every module shares the same audit trail, the same user authentication, and the same record structure as the rest of your NetSuite instance.
Document Control enforces version control, record locking, and multi-user collaboration per 21 CFR Part 11. Training is auto-assigned on onboarding, role changes, or document updates. CAPAs are auto-generated based on priority settings. Inspections run at order receipt or assembly build with automatic inventory transfer on pass.
Key features
Built natively inside NetSuite.
No integrations to configure. No external vendors to manage. Every capability lives where your operations run.
Document Control
Version control and record locking
Only current document versions are active. Record locking prevents edits during review. Multi-user collaboration with full audit trail per 21 CFR Part 11.
Training Records
Automatic training assignment
Training assigned automatically on onboarding, role change, or controlled document update. Supports read-and-understand, classroom, virtual, and on-the-job types.
CAPA
Automated CAPA management
CAPAs generated based on priority settings. Effectiveness check records assigned after closure. Follow-up CAPAs triggered if effectiveness criteria are not met.
Inspections
QMS Inspections at receipt and build
Qualitative and quantitative inspection plans for lot and serialized items. Triggered at order receipt or assembly build. 21 CFR Part 11 e-signatures enforced on results.
Inspections
Instant inventory transfer on pass
Inventory transferred automatically to accepted lot on inspection pass. Failed lots placed on hold pending CAPA resolution.
Calibration
Equipment calibration and PM
Full equipment register with service history, calibration schedules, and lifecycle enforcement. Overdue calibration alerts prevent out-of-tolerance equipment from remaining in service.
How it works
From setup to live in days, not months
Configurable without custom coding. Every step runs inside your existing NetSuite instance.
- 01
Configure document types and workflows
Configure document types, training roles, and approval workflows for your quality management structure. E-signature requirements set per document type.
- 02
Controlled documents route through approval
Controlled documents route through built-in approval with e-signatures enforced per 21 CFR Part 11. Version control and record locking applied automatically.
- 03
Training assigned automatically
Training records assigned automatically on onboarding, role change, or controlled document update. Due dates tracked with reminders and escalations.
- 04
Inspections run at receipt or build
QMS Inspections triggered at order receipt or assembly build. Instant inventory transfer to accepted lot on pass. Failed inspections generate quality events automatically.
- 05
CAPAs tracked and closed with effectiveness
CAPAs generated, tracked, and closed with effectiveness verification. Follow-up CAPAs triggered automatically if effectiveness criteria are not met.
Who it is for
Built for FDA-regulated companies on NetSuite
Life sciences and healthcare teams that need enterprise-grade capabilities without leaving NetSuite.
Biotech and Pharma
GMP quality management from IND to commercial
Pharma and biotech companies need a QMS that scales from investigational phase through commercial manufacturing with the same audit trail and e-signature controls at every stage.
CDMO
Multi-client quality event management
CDMOs managing quality events across multiple client programs need CAPA, inspection, and document control that maintains client-level separation within one system.
Medical Device
21 CFR 820 quality system requirements
Device manufacturers under QSR requirements need document control, CAPA, and inspection records that satisfy FDA quality system regulation requirements natively in their ERP.
Cell and Gene Therapy
GMP and GTP quality management
Cell and gene therapy companies operating under GMP and GTP frameworks need a QMS with e-signature controls, training records, and CAPA management built for biologics manufacturing.
CRO
Study documentation and quality controls
CROs managing clinical quality events and study documentation need CAPA tracking and training records that connect quality events to the studies and sponsors they affect.
Radiopharmaceuticals
Short half-life batch release inspection
Radiopharmaceutical manufacturers need rapid inspection workflows that trigger on batch completion and support immediate inventory release with a compliant audit trail.
Ready to see it live?
Bring Quality Management System into your NetSuite environment
Talk with Archer about the workflow, controls, and deployment path for your team.