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RegDeskRegDesk is the most comprehensive AI-enabled RIMS platform for Medical Devices, Pharmaceuticals, and IVD companies. • Our proprietary Regulatory Intelligence for over 120+ countries is translated and accessible in a standard format. In addition, it provides alerts on evolving regulatory changes • Our AI-powered Application Builder allows RA teams to prepare and publish global applications in 1/10th of the time • Our Change Assessment capability helps RA teams understand the impact of the change(s) on an existing product(s) and the action required • Our Distributor Collaboration provides seamless workflow solutions to interact, communicate, and share documents with external business partners • Our Standards Management makes it easy for RA teams to search and manage not only international but also country-specific standards • Our Tracking & Reporting functionality allows teams to track regulatory projects across the globe, receive renewal notifications, and generate reports on KPIs within seconds For more information, visit our website.
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.
Description
What is my inventory situation today for any item? What are we stocking and how often? What are my delivery times We shipped late because of this. Is there too much inventory in one area and not enough in the other? What is my supplier lead time? These are simple questions that we all ask every day. The answers can reveal the root causes of supply chain problems and help improve supply chain performance. These answers are often difficult to find because the data is locked in your ERP and only accessible via limited reports views or spreadsheets. These reports can be created manually in Excel using data imports, reformatting and distribution to key stakeholders. This wastes valuable planning time. This means that updating information is not always possible.
API Access
Has API
No
API Access
Has API
No
Integrations
No details available.
Integrations
No details available.
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
No
iPhone App
No
iPad App
No
Android App
No
Windows
No
Mac
No
Linux
No
Chromebook
No
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)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
No
Vendor Details
Company Name
IDBS
Founded
1989
Country
United Kingdom
Website
skylandanalytics.net
Vendor Details
Company Name
Smart Software
Founded
1981
Country
United States
Website
www.smartcorp.com
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
Product Features
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
Yes
Visualization
No
