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QualityControlSoftware.com
Cloud, On-PremisePer User/Month

MasterControl

Manufacturing Excellence platform unifying Quality, Manufacturing, and Asset Excellence — with market-leading electronic Batch Records (EBR), electronic Device History Records (eDHR), electronic logbooks, and AI-powered analytics (MasterControl Insights). MasterControl integrates with CI/CD platforms like Jenkins for automated batch record deployment, enabling manufacturers to push validated EBR/eDHR configurations through staging and production environments with full audit trail control.

Medical DevicePharmaceuticals & BiotechnologyBiotechnologyAutomotiveAerospace & DefenseGeneral Manufacturing

Regulated manufacturers needing end-to-end Manufacturing Excellence: EBR/eDHR, electronic logbooks, AI analytics, and validated Part 11 compliance

Starting: $200/user/month (core); EBR/eDHR/Insights add-ons priced per module/site · Implementation: $100,000–$500,000+ depending on scope (EBR, eDHR, Insights, multi-site) · Contract: Annual (3–5 year typical for enterprise); multi-site volume discounts
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Feature Overview

Key capabilities of MasterControl.

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
1993
Employees
800+
Headquarters
Salt Lake City, UT, USA
Target Size
Enterprise

Compliance & Validation

Validation Status
Fully Validated
Implementation Speed
Medium (12–24 weeks)
Implementation Time
28 weeks
Trial Available
Demo Only

Pricing Details

Model
Per User/Month
Starting Price
$200/user/month (core); EBR/eDHR/Insights add-ons priced per module/site
Implementation Fee
$100,000–$500,000+ depending on scope (EBR, eDHR, Insights, multi-site)
Training Included
No
Contract Term
Annual (3–5 year typical for enterprise); multi-site volume discounts

Notable Customers

  • Medtronic
  • Abbott
  • Thermo Fisher
  • Baxter
  • Caterpillar
  • Boston Scientific
  • Stryker
  • Johnson & Johnson
  • Merck
  • Pfizer

Integrations

SAPOracleVeevaSalesforceArena PLMPTC WindchillRockwell AutomationSiemensHoneywellAVEVAOSIsoft PIMuleSoftDell Boomi

Support & SLA

EmailPhoneDedicated CsmKnowledge BaseOn SiteCommunity
SLA
4-hour critical response; 24/7 enterprise support available; TAM option for strategic accounts

Technical Details

Mobile App
Yes
Offline Capability
Yes
Languages
English, Spanish, French, German, Chinese, Japanese, Portuguese, Italian, Korean
Data Residency
US, EU, Canada, Australia, AWS GovCloud, Azure Government, GCP Assured Workloads
Security Certs
SOC 2 Type II, ISO 27001, FedRAMP Moderate, HIPAA
API Docs
View Documentation

Compliance Matrix

MasterControl alignment with key regulatory standards.

Standard / RegulationSupported
ISO9001
ISO13485
ISO14971
FDA21CFR820
FDA21CFR11
MDSAP
EUMDR
IATF16949
AS9100

Certifications

ISO 9001ISO 13485ISO 14971FDA 21 CFR 820FDA 21 CFR Part 11MDSAPEU MDRIATF 16949AS9100

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