Regulatory Information
Management Systems

THE CHALLENGE

A lengthy, complex process

Successfully traversing and managing the complex regulatory landscapes of the pharmaceutical and medical device industries requires a software solution that consolidates regulatory and quality processes. Streamline data sharing with one core solution – from submission management and validation to product information and lifecycle management.

The need to interact, collaborate, and coordinate

It has become increasingly difficult to maintain information concerning the registration status and licensing conditions of all company products on a global basis, while supporting correspondences with regulatory agencies to monitor regulatory history, approval conditions, commitments, and quality aspects of products in any given country.

THE SOLUTION

Complete and Cost-effective RA Process Automation

Dot Compliance’s regulatory information management solution breaks down the traditional siloed approach of communication with regulatory agencies and personnel. Manage all regulatory data and documentation, and registration of products, product variation, and registration renewals in one system. Integration with document control and other system capabilities provides flexible, complete, and cost-effective RA process automation.

Improved collaboration

Automate regulatory and quality processes under one system.

Real-time communication

Track the entire product lifecycle with advanced metric and KPI reporting through easy to use dashboards.

Streamlined global submissions

Compliance with regulatory bodies, supporting correspondences with regulatory agencies in any given country.

Automate regulatory and quality processes under one system.

Track the entire product lifecycle with advanced metric and KPI reporting through easy to use dashboards.

Compliance with regulatory bodies, supporting correspondences with regulatory agencies in any given country.

Improved collaboration

Real-time communication

Streamlined global submissions

PROCESSES COVERED

  • Product registration
  • Dossier file/Binders (document and binder)
  • Registration/submission
  • Variation Management (change management)
  • Renewal management
  • Regulatory correspondence management
  • Regulatory commitment tracking
FEATURES & BENEFITS

Simplified & effective registration management

  • Solution is compliant with strict industry standards such as 21 CFR Part 11.
  • Document control integration Includes validation package and project validation services.
  • Automated tracking of the entire registration submission process.

Experience ready to use QMS

Explore Dot’s products

No matter what your quality and compliance needs are, we have a solution for you.

QMS Xpress Symbol

QMS Xpress

Set your eQMS foundation with a comprehensive set of ready to use core quality processes

Xpand

Compliance Xpand

Build upon core eQMS, expanding into other manufacturing quality and compliance specialty areas

Xact

Enterprise Xact

Tailored eQMS, with customized and configured quality and compliance processes based on your unique requirements