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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 Skyland PIMS?

Skyland PIMS® presents a holistic approach to managing product and process data from start to finish. This collaborative platform caters to both new and established global drug sponsors as well as contract manufacturing organizations (CMOs), enabling them to efficiently manage critical information related to development, manufacturing, and quality assurance. With its cloud-based framework and validatable software, it offers rapid implementation and lowers the total cost of ownership (TCO). The system helps maintain data consistency, clarity, and oversight throughout the entire supply chain, leading to faster and more effective scaling, technology transfers, and market launches. Users can effortlessly capture batch details and leverage summary dashboards for efficient data monitoring, release tracking, analysis, and reporting. Additionally, the platform simplifies the oversight of product and process specifications, along with target control limits, while facilitating easy audit trail generation. Moreover, it adeptly integrates batch and limits data to produce valuable process analysis and control charts. Compliance with CPV/APR reporting mandates is straightforward, all while upholding a continuous library of product and process data that ensures transparency and integrity across international networks. By optimizing data management across the product lifecycle and supply chain, Skyland PIMS® bolsters operational efficiency and strengthens collaboration among stakeholders. This cutting-edge approach not only enhances regulatory compliance but also encourages a culture of ongoing improvement within organizations, ultimately leading to better outcomes in drug development and manufacturing. As a result, stakeholders can expect increased productivity and a more responsive supply chain.

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Media

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

Standard Support

Training Options

Not specified

Training Options

Documentation Hub
Online Training
On-Site Training

Company Facts

Organization Name

anic GmbH

Date Founded

1996

Company Location

Germany

Company Website

www.anic-gmbh.de

Company Facts

Organization Name

IDBS

Date Founded

1989

Company Location

United Kingdom

Company Website

skylandanalytics.net

Categories and Features

Categories and Features

Life Sciences

Not specified

SPC

Not specified

Statistical Analysis

Not specified

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