Quality Management System

Quality is most important for Pharmaceutical company

With increasing stringent guidelines and regulatory compliance, quality stands as core competitive advantage for pharmaceutical organizations. Ensure your products are at par with the market needs and best in quality, with Ecomplianceplus automated, integrated QMS (eQMS) platform.

eQMS provides most flexible and scalable QMS system for small startups to large enterprises achieving superior quality, in compliance with MHRA, EMA, FDA or ISO, quality management guidelines. The eQMS offered by Ecomplianceplus allows companies to eliminate paper-based quality processes and drastically increase efficiency while improving their ability to maintain compliance with regulatory standards.


Key Features

Replacing Paper-based Quality Management Systems with Automated Quality Management

eQMS allows you to define, track and manage all of the individual quality processes that are critical to regulated environment with full audit trail. This reduces your cost of compliance, protect your business for long term and increases your competitive advantage.

To ensure that your business continues to operate at the peak of efficiency or to accommodate growth or change, we provide ongoing upgradation, training and support services.

We work closely with regulatory bodies like the MHRA, EMA, FDA to stay on top of regulatory requirements. eQMS are designed to comply with the most rigorous regulations GAMP 5 guidelines (including EU Annex 11, CFR part 21 and ICH) and standards (ISO, GxP, EU GMP). QMS streamlines majority of all critical pro-cesses, improving overall product quality and increases market speed.

  • Manage all quality control processes in a centralized database
  • Enable site level, process level and role-based security
  • Streamline workflow processes
  • Powerful status reports and metrics
  • Make changes to the system seamlessly using point-and-click configura-tion tools - Admin Panel
  • Configure workflow quality systems management tools with no need for customization
  • Upgrade seamlessly and cost effectively
  • Easy to use and intuitive interface
  • Robust interoperability without having the make any changes to the core application

Key Modules

All in one place and easy to access.

Change Control (eChangeControl)

Complaint Management (eComplaint)

  • Streamlines the complaint handling process
  • Stepwise process is incorporated in a pre-configured, multi-page form that starts with the recording of a customer complaint, immediate action, automatically moving to internal investigation, in built root cause analysis techniques and culminating with a resolution of the issue to complainer
  • Advanced reporting capabilities increase management oversight and demonstrate appropriate controls to regulatory agencies
  • Allows to communicate with the regulatory authority and the pharmacovigilance system for any adverse reaction

Error / Deviation Management (eDeviation)

Document Control System (eDocument)

Audit Management (eAudit)

CAPA Management (eCAPA)

Training Matrix (eTrainingMatrix)

QMS Dashboard (eDashboard)