Average Ratings 0 Ratings
Average Ratings 0 Ratings
Description
Qualitum is an innovative platform designed for computer system validation (CSV/CQV) specifically tailored for the regulated life sciences sector. It automatically generates IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents such as URS, P&IDs, and SOP libraries, ensuring that each requirement is tracked comprehensively through a queryable graph that eliminates the need for traditional spreadsheet RTMs. The platform maintains strict adherence to ALCOA+ data integrity standards, monitoring every record instead of just samples, while allowing human reviewers to validate and approve the outputs produced by the agent. Qualitum operates on a single-tenant basis across AWS, Azure, or on-premises environments, empowering customers with control over their keys and prohibiting any training rights on customer data. It seamlessly integrates with existing systems of record, including Veeva, MasterControl, TrackWise, AVEVA PI, Tulip, and others, making it a versatile choice for organizations. Designed with the needs of Heads of Validation and validation consultancies in mind, it serves stakeholders in the pharmaceutical, biotechnology, and medical device industries. Interested parties can obtain a per-site annual license quote upon request, and a fixed-fee pilot program lasting 8-12 weeks is offered for a single system to facilitate an initial experience. This comprehensive approach ensures that organizations can achieve their validation goals efficiently while maintaining compliance in a highly regulated environment.
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
No
API Access
Has API
No
Screenshots View All
No images available
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
Yes
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
No
Live Rep (24/7)
No
Online Support
No
Customer Support
Business Hours
Yes
Live Rep (24/7)
No
Online Support
No
Types of Training
Training Docs
No
Webinars
No
Live Training (Online)
No
In Person
No
Types of Training
Training Docs
Yes
Webinars
No
Live Training (Online)
Yes
In Person
Yes
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
IDBS
Founded
1989
Country
United Kingdom
Website
skylandanalytics.net
Product Features
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