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Description
BeeCTD offers a comprehensive eCTD management system tailored for pharmaceutical companies and regulatory bodies. With its modular design and clear licensing approach, users can select the specific modules they wish to utilize, such as Reader, Compiler, and Validator. The advanced Reader provides insights into the complete lifecycle of the dossier, accommodating both eCTD and NeeS sequences, and facilitates the transition between the two formats, including baseline submissions. Additionally, the real-time sequence validator ensures compliance with the eCTD/NeeS technical specifications, incorporating best practices, while always reflecting the latest validation criteria, with older versions accessible for reference. Users can seamlessly compile their documents into an eCTD-compliant format, leveraging our eCTD compiler tool, which they can use independently or as an on-demand service where we handle the compilation for them. Moreover, the flexibility and scalability of BeeCTD make it an ideal choice for organizations seeking to enhance their regulatory submission processes.
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.
API Access
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API Access
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Free Trial
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Free Version
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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
Yes
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
Yes
Customer Support
Business Hours
No
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
No
Webinars
No
Live Training (Online)
No
In Person
No
Vendor Details
Company Name
Altamira
Founded
2009
Country
Slovakia
Website
www.altamira.ai/beectd/
Vendor Details
Company Name
Qualitum
Website
qualitum.ai
