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What is anicomply?

Anicomply represents an innovative Electronic Batch Record (EBR) system specifically designed for pharmaceutical manufacturers, contract development and manufacturing organizations (CDMOs/CMOs), active pharmaceutical ingredient (API) producers, and a range of other sectors where maintaining high quality is critical. This platform transforms conventional paper-based or hybrid batch processes into streamlined, executable workflows, setting itself apart with impressive speed; a typical recipe can swiftly transition from a standard operating procedure (SOP) to an active digital workflow within hours instead of the usual weeks required. Utilizing a declarative approach, process owners can make a variety of workflow adjustments with limited input from developers, which significantly cuts down on programming needs, shortens iteration cycles, and eases resource limitations. The system is equipped with vital features, including an integrated audit trail, electronic signatures, version control, and a four-eyes review process, all designed to inherently fulfill GxP compliance standards. Being a web-based application, it functions effortlessly across multiple devices and provides both cloud and on-premises deployment alternatives, while also allowing for seamless integration with ERP, MES, and SCADA systems. Moreover, anicomply produces structured process data that not only enhances review-by-exception capabilities but also ensures traceability, supports analytics, and lays the foundation for future artificial intelligence applications. This all-encompassing functionality not only streamlines operational efficiency but also reinforces regulatory compliance in manufacturing processes, ultimately helping organizations achieve their quality and compliance objectives more effectively.

What is Arena QMS?

Arena's quality management system (QMS) software is designed to help medical device manufacturers efficiently launch safe and compliant products in the marketplace. By integrating quality and product workflows, Arena QMS facilitates a smoother new product development and introduction (NPDI) process. It guarantees adherence to various quality standards and regulatory requirements, such as FDA 21 CFR Part 820, Part 11, and ISO 13485. Furthermore, Arena QMS enhances visibility and traceability by overseeing quality processes in relation to bills of materials (BOMs), device master records (DMRs), standard operating procedures (SOPs), along with specifications, drawings, and training documentation. This holistic approach not only supports regulatory compliance but also fosters a culture of quality throughout the organization.

Media

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Media

Integrations Supported

Rimsys

Integrations Supported

Rimsys

API Availability

Has API

API Availability

Has API

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Pricing Information

Pricing not provided.
Free Trial Offered?
Free Version

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Supported Platforms

SaaS
Android
iPhone
iPad
Windows
Mac
On-Prem
Chromebook
Linux

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Customer Service / Support

Standard Support
24 Hour Support
Web-Based Support

Training Options

Documentation Hub
Webinars
Online Training
On-Site Training

Training Options

Documentation Hub
Webinars
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

Arena, a PTC Business

Date Founded

2000

Company Location

United States

Company Website

www.arenasolutions.com/platform/qms/

Categories and Features

Categories and Features

Quality Management

Audit Management
Complaint Management
Compliance Management
Corrective and Preventive Actions (CAPA)
Defect Tracking
Document Control
Equipment Management
ISO Standards Management
Maintenance Management
Risk Management
Supplier Quality Control
Training Management

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