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Average Ratings 4 Ratings

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support

Description

Compliance Builder™, a real-time monitoring tool, is designed to enable 21 CFR Part 11 compliance. It provides data integrity across IT systems such file systems, laboratory and manufacturing instruments, as well as providing file system, database, laboratory, and manufacturing instrument data integrity. Compliance Builder allows you secure track all IT subsystems, including file systems, databases and laboratory equipment. It can be set up to monitor any file-based system, including file modifications and additions.

Description

SciCord Solution features are designed to help your company transition quickly into the digital age. SciCord ELN/LIMS can be used to ensure compliance in both manufacturing and laboratory settings. Validated formulas can improve compliance and eliminate errors in calculation. To ensure compliance with SOPs, create lists. Automatic entry verification to flag possible Out-Of-Specification scenarios. Restrictions to prevent the use of expired solutions and ensure that equipment is only used by trained personnel. Intelligent scans alert reviewers to potential issues such as unstable balance, precision, uncalibrated equipment, and unvalidated process. Fully compliant with CFR 21 Part11, including electronic signatures. Custom parsing of attached files extracts data and records it in SciCord experiments for additional calculations and statistical analysis.

API Access

Has API

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

JMP Statistical Software
Microsoft Entra ID
Microsoft Excel
Microsoft Power BI
Microsoft SharePoint
Spotfire

Integrations

JMP Statistical Software
Microsoft Entra ID
Microsoft Excel
Microsoft Power BI
Microsoft SharePoint
Spotfire

Pricing Details

25000.00
Free Trial
Free Version

Pricing Details

$220/user/month
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

Xybion

Founded

1977

Country

United States

Website

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

Vendor Details

Company Name

SciCord

Country

United States

Website

scicord.com/scicord-eln/core-features/

Product Features

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

Data Governance

Access Control
Data Discovery
Data Mapping
Data Profiling
Deletion Management
Email Management
Policy Management
Process Management
Roles Management
Storage Management

Database Monitoring

Anomaly Detection
Autodiscovery
Capacity Planning
Dashboard
Dependency Tracking
Historical Trend Analysis
Multitenancy
Notifications / Alerts
Performance Monitoring
Permissions / Access Controls
Predictive Analytics
Prioritization
Query Analysis
Resource Optimization
Troubleshooting

Digital Signature

Audit Trail
Authentication
Auto Reminders
Customizable Templates
Document Analytics
Mobile Signature
Multi-Party Signing
Progress Tracking
Task Progress Tracking

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

ELN

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

Scientific Data Management System (SDMS)

Analytics
Artificial Intelligence (AI)
Audit
Centralized Data Repository
Collaboration
Compliance
Data Security
ELN Integration
LIMS Integration
Workflows

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