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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
When production instructions change, the work does not end with a revised document. Production needs a usable process, QA needs a clear record, and IT/OT needs a solution that fits the plant.
anicomply is an eBR-first Intelligence Platform built around that shared challenge in regulated manufacturing.
Existing, structured Microsoft Word recipes and manufacturing instructions become the foundation for executable digital batch workflows, not just electronic copies of paper records.
A declarative, no-code-oriented approach helps process teams create and adjust workflows with less reliance on custom programming. Depending on configuration, audit trails, electronic signatures, version control and four-eyes review support controlled processes. Structured execution data can make events easier to trace and help QA focus on exceptions during batch review.
The browser-based application supports mobile use and deployment in the cloud or on premises. Integration with ERP, MES and SCADA systems is assessed and scoped to the specific project. anicomply is relevant to pharmaceutical and biotech manufacturers, CMOs, CDMOs, API producers and quality-critical chemical operations with changing recipes or product variants.
API Access
Has API
No
API Access
Has API
No
Screenshots View All
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Screenshots View All
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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
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
Qualitum
Website
qualitum.ai
Vendor Details
Company Name
anic GmbH
Founded
1996
Country
Germany
Website
www.anic-gmbh.de