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Description

AlisQI is a cloud-based Quality Management platform built for process and batch manufacturers who want to move beyond reactive firefighting toward stable, predictable operations while maintaining full compliance control. Rather than organizing quality around static documents and isolated events, AlisQI was designed as a data-first system. Quality, laboratory, and production data are structured and connected in a shared operational backbone. This gives cross-functional teams early visibility into deviations, faster response times, and greater confidence in product integrity and daily execution. The platform combines configurable quality modules, including document control, training, deviations, CAPA, audits, risk management, supplier quality, SPC, and EHS, with targeted, ready-to-use Solvers. Solvers integrate forms, workflows, dashboards, and business logic to address specific operational problems without unnecessary scope. Because the system is built on structured data, manufacturers can apply practical AI within workflows, from automated COA extraction to conversational access to quality data and pattern detection across incidents. Solvers are production-ready from day one and evolve as processes, products, or plants change. This progression does not require custom development or disruptive IT projects. Manufacturers use AlisQI to harmonize quality practices across sites, reduce waste and rework, strengthen audit readiness, accelerate root cause analysis, and connect shop-floor and lab data directly to quality decision-making across industries including chemicals, plastics, packaging, food and beverage, personal care, automotive, and industrial manufacturing.

Description

Workflows are specifically developed to assist you in preparing all necessary components for a 510(k) submission, while also ensuring compliance with the quality record requirements set forth in 21 CFR Part 820 as you prepare to market your device. These workflows come equipped with tools to facilitate the drafting of essential policies, procedures, and work instructions. Furthermore, you can monitor non-conformances, deviations, and CAPAs through tailored quality management reports. As your processes evolve and enhance, you can ensure your team receives automatic training updates. The system also automates validation testing for devices, applications, websites, and custom software tailored to your business needs. This automation significantly reduces the time and resources that would otherwise be consumed by extensive testing, reporting, and approval processes. Additionally, you can compile all your policies, procedures, and artifacts into standard documents, making them readily available for audit evaluations. Overall, this solution streamlines the compliance and validation processes, thereby enhancing operational efficiency.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

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

Integrations

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

Pricing Details

$1000 per month
Free Trial
Free Version

Pricing Details

No price information available.
Free Trial
Free Version

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Deployment

Web-Based
On-Premises
iPhone App
iPad App
Android App
Windows
Mac
Linux
Chromebook

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Customer Support

Business Hours
Live Rep (24/7)
Online Support

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Types of Training

Training Docs
Webinars
Live Training (Online)
In Person

Vendor Details

Company Name

AlisQI

Founded

2002

Country

Netherlands

Website

www.AlisQI.com

Vendor Details

Company Name

Sierra Labs

Country

United States

Website

www.sierralabs.com/quality-management/

Product Features

CAPA

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

LIMS

Audit Trail
Certificates of Analysis
Data Import / Export
Electronic Laboratory Notebook
Inventory Management
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

Product Features

CAPA

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

Compliance

Archiving & Retention
Artificial Intelligence (AI)
Audit Management
Compliance Tracking
Controls Testing
Environmental Compliance
FDA Compliance
HIPAA Compliance
ISO Compliance
Incident Management
OSHA Compliance
Risk Management
Sarbanes-Oxley Compliance
Surveys & Feedback
Version Control
Workflow / Process Automation

Document Control

Archiving & Retention
Automated Routing
Change Management
Compliance Management
Electronic Signature
Escalation Management
Periodic Review
Version Control

Document Version Control

Access Controls/Permissions
Approval Process Control
Archiving & Retention
Audit Trail
Commenting / Notes
Document Check-in / Check-out
For Engineering Documents
Revision History
Version Comparison
Version Rollback

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

Risk Management

Alerts/Notifications
Auditing
Business Process Control
Compliance Management
Corrective Actions (CAPA)
Dashboard
Exceptions Management
IT Risk Management
Internal Controls Management
Legal Risk Management
Mobile Access
Operational Risk Management
Predictive Analytics
Reputation Risk Management
Response Management
Risk Assessment

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