QMS Software Built for US Businesses
Streamline FDA, ISO 9001, ISO13485, HACCP, cGMP and other compliances in one connected platform. Automate Audits, CAPA, Risk & Document-control.
No credit card required
Pre-validated platform
Trusted by Quality Teams Across North America
G2
Leader · Spring '26
★
4.7 / 5.0
SF
SourceForge Top Performer
CT
Capterra Best Value
SH
SaaS Hub High Rated
Pre-Validated For US Manufacturing
Built to Pass Every Audit, on the First Try
Every TecWrk QualityPro deployment is pre-validated against the standards that matter to US manufacturers — from FDA-regulated life sciences to AS9100 aerospace.
FDA
21 CFR Part 11
Electronic records & signatures
FDA
FSMA
Food Safety & Preventive Controls
GxP
GMP
Manufacturing Quality
GxP
GDP
Distribution Quality
GxP
GRP
Regulatory Documentation
ICH
ICH Q9
Quality Risks and Compliance
ICH
ICH Q 10
Pharmaceutical Quality System
ISO
ISO 13485
Medical Devices Regulatory Compliance
ISO
ISO 22000
Food & Safety Management
ISO
ISO 9001:2015
Process Excellence & Customer Satisfaction
IATF
IATF 16949
Automotive Quality and Supplier Quality
Data Integrity
ALCOA+
Data Integrity, Traceability, Auditability
Built for Quality Teams, by Quality Experts
25+ Connected Modules
Everything you Need for End-to-End Quality Management
One platform, one login, one source of truth — connecting every quality process across your manufacturing operation.
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Core Quality
CAPA Management
Automated workflows for corrective & preventive actions with full root-cause traceability.
Audit Management
Schedule, conduct, and document internal & external audits with auto-generated reports.
Nonconformance
Capture, classify, and resolve nonconforming products in real-time across the shop floor.
Change Control
Manage all changes with cross-functional approvals and impact assessments.
Inspection
Receiving, in-process, and final inspections with digital checklists and pass/fail logic.
Management Review
Pre-built dashboards are available for Management Review purpose as per ISO 9001 & 13485 guidelines
Document Control
Version control, electronic signatures, and Part 11 compliant document workflows.
Training Management
Auto-assigned training when SOPs change. Quiz, certify, and track competency.
SOP Management
Create, approve, distribute, and execute SOPs through a single platform—ensuring every procedure is followed, documented, and audit-ready.
eSignatures
FDA 21 CFR Part 11 compliant electronic signatures with full audit trail.
Calibration
Track equipment calibration schedules, history, and certificates with auto-alerts.
Equipment Maintenance
Preventive maintenance scheduling integrated with calibration and quality events.
Risk Management
FMEA tools, risk scoring, and mitigation tracking aligned to ISO 14971.
Deviation Management
Capture deviations from approved procedures with root cause and CAPA linkage.
Complaint Management
Field complaints, MDR/MIR reporting, and trend analysis in one system.
Supplier Quality
Approve, monitor, and audit suppliers with scorecards and SCAR workflows.
Receiving Inspection
Material receipt inspections linked to supplier scorecards and PO records.
Customer Feedback
Customer complaint portal with auto-routing and SLA tracking.
Why US Manufacturers Choose TecWrk
Modern QMS Without the Legacy Software Headache
Built from the ground up for cloud, AI, and the speed that modern manufacturing demands.
Faster Adoption
Intuitive workflows, visual insights, and guided quality tools accelerate adoption across teams and sites.
Live in 30 Days
Pre-validated environment, pre-built templates for FDA & ISO standards, and a dedicated US-based implementation team.
Bank-Grade Security
SOC 2 Type II, ISO 27001, and CCPA compliant. Hosted on US AWS infrastructure with full data residency control.
Connects to Your Stack
Native integrations with SAP, BatchMaster Web ERP, Odoo, etc., via API.
Mobile & Offline
Built for the shop floor. Capture nonconformances, inspections, and audits even when offline. Auto-sync when reconnected.
Predictable Pricing
Concurrent-user pricing with everything included. No hidden module fees, no per-record charges, no implementation surprises.
Built For Your Industry
Quality Management for Every Regulated Manufacturer
Pre-configured workflows, validation kits, and compliance templates for the industries TecWrk serves.
Medical Devices
ISO 13485, FDA 21 CFR 820, EU MDR — DHF, DMR, eMDR included.
Pharmaceuticals
cGMP, 21 CFR Part 211, GxP — batch records & deviation management.
Automotive
IATF 16949, PPAP, APQP — supplier quality and 8D problem solving.
Food & Beverage
FSMA, HACCP, SQF, BRC — recall management and traceability.
Electronics
IPC standards, RoHS, REACH — supplier & component qualification.
Discrete Manufacturing
ISO 9001 — built for job shops, contract manufacturers, and OEMs.
Financial Services
GLBA, GDPR, DORA and SOX – Ensure data security, privacy, cyber security and corporate financial reporting.
Construction Services
ISO 9001 – Easy CIR submissions, and digital phase reports repository.
Oil & Gas
API, ISO/TS 29001 - Hazard prevention, contingency planning, and product/service quality.
Retail
AML, PCI DSS, ISO 22000, BRCGS - Manage critical control points, cold chains, allergens, and payment security.
Real Results, Real Customers
Measurable Impact from Day One
Aggregated outcomes from 50+ TecWrk QualityPro deployments across US manufacturing, pharmaceutical, and medical device companies.
98%
First-Pass Audit Success
52%
Lower Operational Cost
73%
Faster CAPA Closure
Based on customer-reported data from 50+ QualityPro deployments (2024–2026)
Why US Manufacturers Choose TecWrk
See QualityPro in Action - Tailored to your Industry
A 30-minute walkthrough with a US-based product specialist who knows your regulatory environment.
Live product walkthrough
See the modules that matter for your industry & standards
Custom pricing quote
Transparent concurrent-user pricing — no surprises
Compliance gap analysis
Free assessment of your current QMS vs FDA & ISO requirements
30-day implementation plan
Concrete roadmap to go-live with milestones & deliverables
Request A Demo
Pricing starts at competitive concurrent-user rates. We'll share a custom quote on the call.
TecWrk QualityPro PPC
Ready to Modernize your Quality System?
Join the manufacturers who replaced their legacy QMS with TecWrk QualityPro — and went live in under 30 days.
AI-powered Quality Management Software trusted by US manufacturers for FDA, ISO, and cGMP compliance. The first QMS certified under ISO/IEC 42001.
Contact Us
- +1 (800) 555-0198
- support@tecwrk.com
28 Geary St STE 650 PMB 636, San Francisco,CA, 94108, USA
ST-2, Ground Floor, Brilliant Solitaire, Scheme 78, Indore - 452010 India
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