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Doc for Quality

Enterprise software for efficient management of quality documents following GxP and ISO standards, ensuring compliance and improving operational productivity.

Solution by Ennov
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Overview

Ennov Doc for Quality is an enterprise-quality document management system designed to effectively manage and control GxP documents. This software provides a comprehensive solution to handle documentation securely and efficiently, addressing the challenges faced by companies in highly regulated industries like biopharmaceuticals. These companies require robust systems to manage, track, and provide proof of document creation, editing, review, approval, and issuance as per GxP and ISO standards.

The system eliminates the inefficiencies of storing documents across disparate locations, which often leads to wasted time and increased frustration. It provides unified access to quality documents, featuring a pre-configured document inventory aligned with the DIA GMP Reference Model. The metadata-based document model offers flexibility, and its intuitive design allows for administration without IT skills.

Ennov Doc supports improved productivity through its user-friendly interface and efficient search capabilities, enabling quick access to necessary documents. Integration with Microsoft Office 365 and Google Drive enhances user adoption, promotes collaboration, and accelerates return on investment. The system provides secure document access via an integrated PDF Viewer, which eliminates the need for downloading uncontrolled copies.

Key features include automatic periodic reviews, integrated change control, robust revision management, controlled printing, and electronic signatures for compliance assurance. It supports a wide array of GxP document types, from governance to manufacturing and audit procedures.

The system's high degree of configurability and integration with Ennov's other solutions like Ennov Process, Ennov Dossier, and Ennov Analytics, allows for flexible alignment with corporate standards. Compliance with requirements for electronic signatures and audit trails makes it suitable for industries like pharmaceuticals, biotechnology, and medical devices.

  • Core Capabilities: Pre-configured document inventory, lifecycle management, flexible rights management, PDF rendering, comprehensive search functionality, and integration with Office 365 and Google Drive.
  • Key Features: Integrated work list dashboard, document type and workflow configurability, automated notifications, intuitive interface, web-based access, and 21 CFR Part 11 compliance.

Ennov offers both cloud-based and on-premises deployment options, providing flexibility and autonomy in system management without the necessity for IT skills. The solution supports large global deployments thanks to its scalability and security.

Meta

Category
Regulatory & Quality Compliance
Field(s)
Quality & Compliance
Target user(s)
QA / Regulatory AffairsLab Manager / Core Facility Manager
Tag(s)
Quality & Compliance Management