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Cloud, On-Premise, HybridPer Site/Year

Pilgrim SmartSolve

Enterprise QMS platform with integrated risk management and compliance analytics.

Medical DevicePharmaceuticals & BiotechnologyAutomotiveAerospace & Defense

Enterprise risk & compliance management across pharma/med-device/aerospace

Starting: $75,000/site/year · Implementation: $100,000–$300,000+ · Contract: Multi-year

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Feature Overview

Key capabilities of Pilgrim SmartSolve.

Mobile inspections
Offline mode
Real-time SPC
Supplier portal
Training management
Audit management
API access
21 CFR Part 11
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
200+
Headquarters
Tampa, FL, USA
Target Size
Enterprise

Compliance & Validation

Validation Status
Fully Validated
Implementation Speed
Slow (24+ weeks)
Implementation Time
36 weeks
Trial Available
Demo Only

Pricing Details

Model
Per Site/Year
Starting Price
$75,000/site/year
Implementation Fee
$100,000–$300,000+
Training Included
No
Contract Term
Multi-year

Notable Customers

  • Baxter
  • Cardinal Health
  • Cook Medical
  • Edwards Lifesciences

Integrations

SAPOracleVeevaSalesforceMicrosoft DynamicsArena PLM

Support & SLA

EmailPhoneDedicated CsmKnowledge BaseOn Site
SLA
4-hour critical; 24/7 available

Technical Details

Mobile App
Yes
Offline Capability
No
Languages
English, Spanish, French, German, Chinese, Japanese
Data Residency
US, EU, On-premise
Security Certs
SOC 2 Type II, ISO 27001

Compliance Matrix

Pilgrim SmartSolve 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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