Quality-Based Document Control

Document Management for Enterprise-Wide Collaboration While Ensuring Regulatory Compliance

Strict global regulatory oversight intensifies the pressure as companies struggle to get their products to market while fully meeting regulatory requirements. Quality-Based Document Control optimizes document management in a single, flexible electronic change control process that enables enterprise-wide collaboration to improve operational efficiency and enforce compliance for creating, managing and storing documents in accordance with global regulatory bodies. It provides a configurable and an easy-to-use solution that helps companies automate and effectively manage document control processes to help ensure compliance with FDA regulations, ISO quality standards, and other global regulatory requirements.

Quality-Based Document Control is available on premise.

Key Features and Benefits:

  • Securely automates a change control process based on industry best-practices  such as FDA Part 820, Part 211 and ISO standards
  • Full lifecycle management, controlling, tracing documents through creation, review, edit, approval, release, and implementation, along with affected documents
  • Closed-loop routines to manage document revisions and change control with automated approval routings and email notifications
  • iMajor, minor revisions are tracked; departments, groups and individuals affected by each document are recorded and can receive automated changes notices