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features
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support

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Write a Review

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 

Screenshots View All

Screenshots View All

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 
Oracle Cloud Infrastructure Yes 
Oracle PeopleSoft Yes 
QAD Adaptive ERP Yes 
QUMAS EQMS Yes 
SAP Analytics Cloud Yes 
SAP BusinessObjects Business Intelligence Yes 
SAP CRM Yes 
SAP Crystal Reports Yes 
Salesforce Yes 
Tech Cloud ERP 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 
Oracle Cloud Infrastructure No 
Oracle PeopleSoft No 
QAD Adaptive ERP No 
QUMAS EQMS No 
SAP Analytics Cloud No 
SAP BusinessObjects Business Intelligence No 
SAP CRM No 
SAP Crystal Reports No 
Salesforce No 
Tech Cloud ERP 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 

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