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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 Agatha?

Agatha offers a wide array of cloud-based solutions meticulously tailored for the life sciences industry, which enables the centralized management of documents and processes associated with clinical operations, quality assurance, regulatory compliance, and training initiatives. This innovative platform is designed to support the unique workflows of biotech companies, pharmaceutical enterprises, medical device producers, and contract research organizations, providing various modules such as eTMF (Inspection-Ready Master Trial File), Remote ISF (Investigator Site File) management, and tools for developing and approving standard operating procedures (SOPs), in addition to managing quality documents for CAPAs, deviations, and change controls. Furthermore, Agatha streamlines the handling of regulatory documents, ensuring the seamless creation, review, approval, storage, and sharing of materials within an integrated system. By advocating for a paperless environment, it reduces administrative burdens and enhances data security, all while being built on a framework that adheres to global compliance standards like 21 CFR Part 11, GDPR, and EU Annex 11. Ultimately, Agatha equips life sciences organizations with the tools necessary to refine their operations and uphold adherence to industry regulations more effectively, paving the way for improved efficiency and innovation in the sector. With its robust features, the platform not only simplifies complex processes but also supports organizations in achieving their strategic goals.

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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

Customer Service / Support

Not specified

Customer Service / Support

24 Hour Support
Web-Based Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training

Company Facts

Organization Name

anic GmbH

Date Founded

1996

Company Location

Germany

Company Website

www.anic-gmbh.de

Company Facts

Organization Name

Agatha

Date Founded

2015

Company Location

United States

Company Website

en.agathalife.com

Categories and Features

Categories and Features

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