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What is Compliance Builder?

Compliance Builderâ„¢ is a monitoring solution that operates in real time to ensure adherence to 21 CFR Part 11 regulations. This tool guarantees data integrity throughout various IT infrastructures, encompassing file systems, laboratory devices, and manufacturing instruments, while also ensuring the integrity of data from those sources. With Compliance Builder, you can safely oversee all IT subsystems, which include not only file systems and databases but also laboratory apparatus. The system can be configured to track any file-based platform, monitoring changes and additions to files effectively. Furthermore, its robust capabilities provide users with comprehensive oversight of their compliance landscape.

What is AlisQI?

AlisQI is a Quality Management platform built for process and batch manufacturers who want operational control without adding administrative overhead. Where many QMS platforms were designed around document storage and event tracking, AlisQI was architected as a data-first system. Quality, laboratory, and production data are structured and connected in a single operational backbone. This enables teams to see deviations earlier, understand performance trends in context, and act before issues escalate into waste, rework, or customer complaints. The platform includes modular capabilities across document control, training, deviations, CAPA, audits, risk management, supplier quality, SPC, and EHS. These capabilities are deployed through focused, ready-to-use Solvers that combine workflows, logic, dashboards, and analytics to address specific operational challenges without unnecessary scope. Because the system is built on structured, connected data, manufacturers can apply practical AI directly inside their workflows. This includes automated extraction of supplier COA data without predefined templates, conversational access to quality records, intelligent rule generation, and pattern recognition across incidents to strengthen corrective action effectiveness. Solvers are production-ready from the outset and evolve as products, processes, or sites change. Improvements do not require custom development or large IT programs, allowing organizations to modernize quality step by step. Manufacturers across chemicals, plastics, packaging, food and beverage, automotive, and industrial sectors use AlisQI to reduce firefighting, increase predictability, strengthen compliance, and turn quality data into operational intelligence.

Media

Media

Integrations Supported

Microsoft SharePoint

Integrations Supported

Boomi
GROW with SAP
Microsoft Dynamics 365
Microsoft Power Automate
NetSuite
Workato

API Availability

API Availability

Has API

Pricing Information

25000.00
Per user and server-based pricing
Free Trial Offered?

Pricing Information

$1000 per month
Pricing starts from around $1,000 per month for a single site and is based on the Solvers you select. Manufacturers can start with only the Solvers they need to address their most urgent quality or operational challenges, then add more over time as needs evolve. Pricing is per site with unlimited users, allowing teams to scale usage without unexpected per-user costs.

Supported Platforms

SaaS
Windows

Supported Platforms

SaaS

Customer Service / Support

Standard Support
Web-Based Support

Customer Service / Support

Standard Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

Xybion

Date Founded

1977

Company Location

United States

Company Website

www.xybion.com/risk-compliance/cqrm-xd/compliance-builder/

Company Facts

Organization Name

AlisQI

Date Founded

2002

Company Location

Netherlands

Company Website

www.AlisQI.com

Categories and Features

Compliance

Audit Management
Compliance Tracking
FDA Compliance
Risk Management
Sarbanes-Oxley Compliance
Version Control

Data Governance

Access Control
Process Management

Database Monitoring

Dashboard
Notifications / Alerts
Permissions / Access Controls
Predictive Analytics

Digital Signature

Audit Trail
Customizable Templates

IT Risk Management

Not specified

LIMS

Not specified

Quality Management

Audit Management
Compliance Management
Document Control

Categories and Features

CAPA

Audit Management
CAPA Planning
Change Management
Complaint Management
Incident Management
Nonconformance Tracking
Quality Control
Risk Management
Root Cause Analysis
Training Management

Lab Automation

Not specified

LIMS

Audit Trail
Certificates of Analysis
Data Import / Export
Lab Instrument Interface
Reporting & Statistics
Sample Tracking
Specification Management
Workflow Management

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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