Cloud, On-Premise, HybridPer Site/Year
Sparta Systems (TrackWise)
Mature enterprise QMS with strong CAPA and compliance tracking for regulated industries.
Pharmaceuticals & BiotechnologyMedical DeviceBiotechnologyAutomotive
Pharma/biotech enterprises requiring mature CAPA, complaints & audit management
Starting: $50,000/site/year · Implementation: $100,000–$500,000+ · Contract: Multi-year typical
Visit Sparta Systems (TrackWise)
Go directly to the vendor's website for the latest information and demo requests.
Visit Website →Feature Overview
Key capabilities of Sparta Systems (TrackWise).
Mobile inspections
Offline mode
Real-time SPC
Supplier portal
Training management
Audit management
API access
21 CFR Part 11
AI-powered insights
Platform customizability
Compliance Certifications
Free trial
NC & CAPA Workflows
Tool Calibration & Metrology
Document Control Sign-offs
Shop Floor Integration
Detailed Specifications
Company Profile
- Founded
- 1994
- Employees
- 300+
- Headquarters
- Hamilton, NJ, USA
- Target Size
- Enterprise
Compliance & Validation
- Validation Status
- Fully Validated
- Implementation Speed
- Slow (24+ weeks)
- Implementation Time
- 52 weeks
- Trial Available
- Demo Only
Pricing Details
- Model
- Per Site/Year
- Starting Price
- $50,000/site/year
- Implementation Fee
- $100,000–$500,000+
- Training Included
- No
- Contract Term
- Multi-year typical
Notable Customers
- Pfizer
- Merck
- Johnson & Johnson
- Amgen
- Bristol Myers Squibb
Integrations
SAPOracleVeevaMasterControlCustom ERP
Support & SLA
- SLA
- 4-hour critical response; 24/7 support available
EmailPhoneDedicated CsmKnowledge BaseOn Site
Technical Details
- Mobile App
- No
- Offline Capability
- No
- Languages
- English, Spanish, French, German, Chinese, Japanese
- Data Residency
- US, EU, On-premise
- Security Certs
- SOC 2 Type II, ISO 27001
- API Docs
- View Documentation
Compliance Matrix
Sparta Systems (TrackWise) alignment with key regulatory standards.
| Standard / Regulation | Supported |
|---|---|
| ISO9001 | |
| ISO13485 | |
| ISO14971 | |
| FDA21CFR820 | |
| FDA21CFR11 | |
| MDSAP | |
| EUMDR | |
| IATF16949 | |
| AS9100 |
Certifications
ISO 9001ISO 13485ISO 14971FDA 21 CFR 820FDA 21 CFR Part 11MDSAPEU MDRIATF 16949
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