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About

Compliance Builder™ is a real-time monitoring solution designed to enable 21 CFR Part 11 compliance, providing data integrity across IT systems such as file systems, database systems, laboratory or manufacturing instruments. By generating an audit trail and enabling electronic signatures, Compliance Builder allows you to securely track changes across all IT subsystems including file systems, databases, laboratory or manufacturing process equipment. It can be configured to monitor any file-based system for changes, including additions, deletions, and file modifications.

About

Engineering teams rely on Instrumental to ship their products sooner, with fewer quality issues. Instrumental delivers AI-powered proactive defect discovery, end-to-end failure analysis tools, and remote real-time build monitoring, all in a single simple cloud platform. Instrumental delivers a unified, traceable data record to help identify and investigate issues starting in your earliest EVT builds. Unify your product data, act on it faster, and leverage AI to solve previously intractable problems on your line. Instrumental unifies your product data to deliver the information you need, when and where you need it, so you can find and fix problems fast. Industrial AI automatically finds and ranks every defect, speeds up failure analysis, and keeps your builds on track. Faster issue resolution starts with the right data in the right place. Instrumental puts a complete product data record including parametric tests, photos, and measurements, at your fingertips.

Platforms Supported

Windows Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Platforms Supported

Windows Not Supported
Mac Not Supported
Linux Not Supported
Cloud Supported
On-Premises Not Supported
iPhone Not Supported
iPad Not Supported
Android Not Supported
Chromebook Not Supported

Audience

Mid market and enterprise clients in manufacturing, life science, financial services, energy, transportation and public sector

Audience

Companies seeking a platform for issue discovery, failure analysis, and quality monitoring

Support

Phone Support Supported
24/7 Live Support Not Supported
Online Supported

Support

Phone Support Not Supported
24/7 Live Support Not Supported
Online Supported

API

Offers API Not Supported

API

Offers API Not Supported

Screenshots and Videos

Screenshots and Videos

Pricing

25000.00
Per user and server-based pricing
Free Version Not Supported
Free Trial Supported

Pricing

No information available.
Free Version Not Supported
Free Trial Not Supported

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Reviews/Ratings

Overall 0.0 / 5
ease 0.0 / 5
features 0.0 / 5
design 0.0 / 5
support 0.0 / 5

This software hasn't been reviewed yet. Be the first to provide a review:

Review this Software

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Training

Documentation Supported
Webinars Supported
Live Online Supported
In Person Supported

Company Information

Xybion
Founded: 1977
United States
www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/

Company Information

Instrumental
United States
instrumental.com

Alternatives

Alternatives

Xybion LIMS

Xybion LIMS

Xybion
LandingLens

LandingLens

LandingAI
Clarity LIMS

Clarity LIMS

Illumina
InstrumentStudio

InstrumentStudio

National Instruments
SampleManager LIMS

SampleManager LIMS

Thermo Fisher Scientific

Categories

Compliance Supported
Data Governance Supported
Digital Signature Supported
IT Risk Management Supported
LIMS Supported
Quality Management Supported

Categories

Industrial AI Supported
Quality Management Supported

Quality Management Features

Audit Management Supported
Complaint Management Not Supported
Compliance Management Supported
Corrective and Preventive Actions (CAPA) Not Supported
Defect Tracking Not Supported
Document Control Supported
Equipment Management Not Supported
ISO Standards Management Not Supported
Maintenance Management Not Supported
Risk Management Not Supported
Supplier Quality Control Not Supported
Training Management Not Supported

Compliance Features

Archiving & Retention Not Supported
Artificial Intelligence (AI) Not Supported
Audit Management Supported
Compliance Tracking Supported
Controls Testing Not Supported
Environmental Compliance Not Supported
FDA Compliance Supported
HIPAA Compliance Not Supported
Incident Management Not Supported
ISO Compliance Not Supported
OSHA Compliance Not Supported
Risk Management Supported
Sarbanes-Oxley Compliance Supported
Surveys & Feedback Not Supported
Version Control Supported
Workflow / Process Automation Not Supported

Data Governance Features

Access Control Supported
Data Discovery Not Supported
Data Mapping Not Supported
Data Profiling Not Supported
Deletion Management Not Supported
Email Management Not Supported
Policy Management Not Supported
Process Management Supported
Roles Management Not Supported
Storage Management Not Supported

Database Monitoring Features

Anomaly Detection Not Supported
Autodiscovery Not Supported
Capacity Planning Not Supported
Dashboard Supported
Dependency Tracking Not Supported
Historical Trend Analysis Not Supported
Multitenancy Not Supported
Notifications / Alerts Supported
Performance Monitoring Not Supported
Permissions / Access Controls Supported
Predictive Analytics Supported
Prioritization Not Supported
Query Analysis Not Supported
Resource Optimization Not Supported
Troubleshooting Not Supported

Digital Signature Features

Audit Trail Supported
Authentication Not Supported
Auto Reminders Not Supported
Customizable Templates Supported
Document Analytics Not Supported
Mobile Signature Not Supported
Multi-Party Signing Not Supported
Progress Tracking Not Supported
Task Progress Tracking Not Supported

Quality Management Features

Audit Management Not Supported
Complaint Management Not Supported
Compliance Management Not Supported
Corrective and Preventive Actions (CAPA) Not Supported
Defect Tracking Not Supported
Document Control Not Supported
Equipment Management Not Supported
ISO Standards Management Not Supported
Maintenance Management Supported
Risk Management Not Supported
Supplier Quality Control Not Supported
Training Management Not Supported

Integrations

Microsoft SharePoint Supported

Integrations

Microsoft SharePoint Not Supported
Claim Compliance Builder and update features and information
Claim Compliance Builder and update features and information
Claim Instrumental and update features and information
Claim Instrumental and update features and information