Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
The AssurX platform is a powerful software platform for enterprise quality management (EQMS) and regulatory compliance to reliably communicate and coordinate information, documentation, and activities. AssurX allows regulated businesses to quickly identify and control quality issues and risk exposure to avoid quality or noncompliance problems while improving workflow. AssurX QMS software is uniquely configurable to fit any established or dynamic business requirements. The system creates an electronic workflow of tasks, alerts, escalations, and approvals that can be automated to the desired level, mapping precisely to real-world operations. No other system is easier to deploy, configure, and modify.
AssurX solutions integrate seamlessly to create a connected quality system. Solutions include audit management, corrective actions, training management, compliant management, document management, change control, risk management, EHS incident management, and more.
Description
Skyland PIMS® offers a comprehensive solution for managing both product and process data from end to end. This collaborative platform is designed for both emerging and established global drug sponsors and contract manufacturing organizations (CMOs), enabling them to effectively handle essential development, manufacturing, and quality information. With its cloud-based architecture and validatable software, the system ensures quick implementation and reduced total cost of ownership (TCO). It allows users to maintain data consistency, comprehension, and oversight throughout the supply chain, resulting in quicker and more effective scale-ups, technological transfers, and commercial launches. Users can easily capture batch information and utilize summary dashboards for effective data monitoring, release tracking, analysis, and reporting. The platform also simplifies the management of product and process specifications along with target control limits while enabling effortless audit trail creation. Furthermore, it seamlessly integrates batch and limits data to generate insightful process analysis and control charts. Compliance with CPV/APR reporting requirements is made straightforward, all while maintaining a persistent library of product and process data that supports transparency and integrity across global networks. By streamlining data management throughout the product lifecycle and supply chain, Skyland PIMS® enhances operational efficiency and collaboration among stakeholders. This innovative approach not only improves regulatory compliance but also fosters a culture of continuous improvement within organizations.
API Access
Has API
Yes
API Access
Has API
No
Integrations
Agile CRM
Yes
Blue Link ERP
Yes
Expandable
Yes
JD Edwards EnterpriseOne
Yes
Microsoft 365
Yes
Microsoft Access
Yes
Microsoft Cognitive Toolkit
Yes
NetSuite
Yes
Oracle BPM Suite
Yes
Oracle CRM On Demand
Yes
Integrations
Agile CRM
No
Blue Link ERP
No
Expandable
No
JD Edwards EnterpriseOne
No
Microsoft 365
No
Microsoft Access
No
Microsoft Cognitive Toolkit
No
NetSuite
No
Oracle BPM Suite
No
Oracle CRM On Demand
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Pricing Details
No price information available.
Free Trial
No
Free Version
No
Deployment
Web-Based
Yes
On-Premises
Yes
iPhone App
Yes
iPad App
Yes
Android App
Yes
Windows
Yes
Mac
Yes
Linux
Yes
Chromebook
Yes
Deployment
Web-Based
Yes
On-Premises
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
Yes
Online Support
Yes
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
Yes
Webinars
Yes
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
AssurX
Founded
1993
Country
United States
Website
www.assurx.com
Vendor Details
Company Name
IDBS
Founded
1989
Country
United Kingdom
Website
skylandanalytics.net
Product Features
Audit
Alerts / Notifications
Yes
Audit Planning
Yes
Compliance Management
Yes
Dashboard
Yes
Exceptions Management
Yes
Forms Management
Yes
Issue Management
Yes
Mobile Access
Yes
Multi-Year Planning
Yes
Risk Assessment
Yes
Workflow Management
Yes
Complaint Management
Case Management
No
Complaint Classification
Yes
Corrective Actions (CAPA)
Yes
Customer Complaint Tracking
Yes
Feedback Management
Yes
Forms Management
Yes
Issue Tracking
Yes
Quality Assurance Management
Yes
Routing
Yes
Self Service Portal
No
Social Media Monitoring
No
Survey Management
No
Compliance
Archiving & Retention
Yes
Artificial Intelligence (AI)
No
Audit Management
Yes
Compliance Tracking
Yes
Controls Testing
Yes
Environmental Compliance
Yes
FDA Compliance
Yes
HIPAA Compliance
Yes
ISO Compliance
Yes
Incident Management
Yes
OSHA Compliance
Yes
Risk Management
Yes
Sarbanes-Oxley Compliance
No
Surveys & Feedback
Yes
Version Control
Yes
Workflow / Process Automation
Yes
Energy Management
Benchmarking
No
Bill Audit
No
Bill Database
No
Bill Importing
No
Budgeting & Forecasting
No
Compliance Management
Yes
Contract Management
No
Cost / Use Reporting
No
Emissions Monitoring
No
Energy Price Analysis
No
Facility Scheduling
No
Greenhouse Gas Tracking
No
Load Control
No
Load Forecasting
No
Meter Tracking
No
Risk Management
Yes
Weather Normalization
No
Manufacturing
Accounting Integration
No
ERP
No
MES
No
MRP
No
Maintenance Management
No
Purchase Order Management
No
Quality Management
Yes
Quotes/Estimates
No
Reporting/Analytics
No
Safety Management
Yes
Shipping Management
No
Quality Management
Audit Management
Yes
Complaint Management
Yes
Compliance Management
Yes
Corrective and Preventive Actions (CAPA)
Yes
Defect Tracking
Yes
Document Control
Yes
Equipment Management
Yes
ISO Standards Management
Yes
Maintenance Management
Yes
Risk Management
Yes
Supplier Quality Control
Yes
Training Management
Yes
Product Features
Manufacturing Intelligence
Aggregation
No
Analysis
No
Contextualization
No
KPIs
No
Propagation
No
Visualization
No
SPC
Corrective Actions (CAPA)
No
Data Entry
No
Data Linking
No
Data Management
No
Excel Loader
No
Job Management
No
OPC Data Collection
No
Performance Metrics
No
Point-of-Production Analysis
No
Real Time Data Collection
No
Regulatory Compliance
No
Statistical Analysis
Analytics
No
Association Discovery
No
Compliance Tracking
No
File Management
No
File Storage
No
Forecasting
No
Multivariate Analysis
No
Regression Analysis
No
Statistical Process Control
No
Statistical Simulation
No
Survival Analysis
No
Time Series
No
Visualization
No