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What is anicomply?

A Word recipe can be a useful starting point for digital manufacturing, but showing that document on a screen is not the same as running a controlled workflow. anicomply is an eBR-first Intelligence Platform: existing, structured Microsoft Word recipes and manufacturing instructions form the basis for executable digital batch processes. Production teams can work with guided steps, while structured process data can support QA traceability and review by exception. Its declarative, no-code-oriented design helps process specialists create or revise workflows with less dependence on programming resources. Audit trails, electronic signatures, version control and four-eyes review support controlled processes according to the agreed configuration. anicomply is browser-based, supports mobile use and can be deployed in the cloud or on premises. Integration with ERP, MES and SCADA systems is assessed and planned for the particular IT/OT landscape. The platform is intended for pharmaceutical and biotech manufacturers, CMOs and CDMOs, API producers and quality-critical chemical operations. A demo or Proof of Value can explore the fit using an existing Master Batch Record.

What is Qualitum?

Qualitum is a cutting-edge platform specifically crafted for computer system validation (CSV/CQV) within the regulated life sciences industry. It automates the generation of IQ/OQ/PQ protocols, GAMP 5 classifications, and audit trails directly from primary documents like URS, P&IDs, and SOP libraries, ensuring thorough tracking of requirements through a queryable graph that replaces the need for traditional spreadsheet RTMs. The platform is committed to upholding stringent ALCOA+ data integrity standards by monitoring every record rather than just samples and enabling human reviewers to validate and approve the outputs generated by its agent. Qualitum functions on a single-tenant basis across AWS, Azure, or on-premises setups, providing customers with control over their keys and preventing any training rights on their data. Its ability to integrate smoothly with existing systems of record such as Veeva, MasterControl, TrackWise, and AVEVA PI makes it an adaptable option for various organizations. Tailored to meet the demands of Heads of Validation and validation consultancies, it supports stakeholders in the pharmaceutical, biotechnology, and medical device sectors. Prospective clients can request a per-site annual license quote, and there is also a fixed-fee pilot program available for 8-12 weeks for a single system, allowing for an introductory experience. This well-rounded approach ensures that companies can efficiently reach their validation objectives while remaining compliant in an increasingly regulated landscape, enhancing the overall effectiveness of their operations.

Media

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Media

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Integrations Supported

Additional information not provided

Integrations Supported

Additional information not provided

API Availability

API Availability

Pricing Information

Pricing not provided

Pricing Information

Pricing not provided

Supported Platforms

SaaS

Supported Platforms

SaaS
On-Prem

Customer Service / Support

Not specified

Customer Service / Support

Not specified

Training Options

Not specified

Training Options

Not specified

Company Facts

Organization Name

anic GmbH

Date Founded

1996

Company Location

Germany

Company Website

www.anic-gmbh.de

Company Facts

Organization Name

Qualitum

Company Website

qualitum.ai

Categories and Features

Categories and Features

Life Sciences

Not specified

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