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features
design
support

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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

API Access

Has API

Screenshots View All

Screenshots View All

Integrations

Agile CRM
Blue Link ERP
Expandable
JD Edwards EnterpriseOne
Microsoft 365
Microsoft Access
Microsoft Azure
Microsoft Cognitive Toolkit
Microsoft Dynamics 365
Oracle BPM Suite
Oracle Business Intelligence (OBIEE)
Oracle CRM On Demand
Oracle Cloud Infrastructure
Oracle PeopleSoft
QUMAS EQMS
SAP Analytics Cloud
SAP BusinessObjects Business Intelligence
SAP Crystal Reports
Salesforce
Tech Cloud ERP

Integrations

Agile CRM
Blue Link ERP
Expandable
JD Edwards EnterpriseOne
Microsoft 365
Microsoft Access
Microsoft Azure
Microsoft Cognitive Toolkit
Microsoft Dynamics 365
Oracle BPM Suite
Oracle Business Intelligence (OBIEE)
Oracle CRM On Demand
Oracle Cloud Infrastructure
Oracle PeopleSoft
QUMAS EQMS
SAP Analytics Cloud
SAP BusinessObjects Business Intelligence
SAP Crystal Reports
Salesforce
Tech Cloud ERP

Pricing Details

No price information available.
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

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
Audit Planning
Compliance Management
Dashboard
Exceptions Management
Forms Management
Issue Management
Mobile Access
Multi-Year Planning
Risk Assessment
Workflow Management

Complaint Management

Case Management
Complaint Classification
Corrective Actions (CAPA)
Customer Complaint Tracking
Feedback Management
Forms Management
Issue Tracking
Quality Assurance Management
Routing
Self Service Portal
Social Media Monitoring
Survey 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

Energy Management

Benchmarking
Bill Audit
Bill Database
Bill Importing
Budgeting & Forecasting
Compliance Management
Contract Management
Cost / Use Reporting
Emissions Monitoring
Energy Price Analysis
Facility Scheduling
Greenhouse Gas Tracking
Load Control
Load Forecasting
Meter Tracking
Risk Management
Weather Normalization

Manufacturing

Accounting Integration
ERP
MES
MRP
Maintenance Management
Purchase Order Management
Quality Management
Quotes/Estimates
Reporting/Analytics
Safety Management
Shipping 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

Manufacturing Intelligence

Aggregation
Analysis
Contextualization
KPIs
Propagation
Visualization

SPC

Corrective Actions (CAPA)
Data Entry
Data Linking
Data Management
Excel Loader
Job Management
OPC Data Collection
Performance Metrics
Point-of-Production Analysis
Real Time Data Collection
Regulatory Compliance

Statistical Analysis

Analytics
Association Discovery
Compliance Tracking
File Management
File Storage
Forecasting
Multivariate Analysis
Regression Analysis
Statistical Process Control
Statistical Simulation
Survival Analysis
Time Series
Visualization

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