QUMAS

• Create and manage SOPs throughout the lifecycle: create, review, edit, approve, distribute and retire
• Ensure that all users have access to the relevant documentation
• Comply with audit trails and 21 CFR Part 11 electronic signatures
• Address deviations and related corrective and preventive actions (CAPA) in real-time, including automatic integration with the relevant document
• Manage the control of change across multiple sites and projects
• Monitor trends and exceptions with dashboards and reports

R&D software for regulatory submissions

The QUMAS software solutions for R&D enable you to manage the creation, review, and approval of all content required for regulatory submissions. They allow the use of eCTD authoring templates for submission readiness and enable you to collaborate on content throughout the product development lifecycle, batch import or scan paper documents, reuse submissions across global regulatory agencies, and monitor progress with dashboards and reports.

Packaged software solutions for QMS and R&D

QUMAS offers a number of packaged solutions that are pre-defined, pre-tested and ready to deploy, including:

• QUMAS CAPA Process Package
• QUMAS Deviation Process Package
• QUMAS Change Control Process Package
• QUMAS Complaints Process Package
• QUMAS Audit Process Package
• QUMAS Quality Documents Package
• QUMAS R&D Submission Documents Package

Each package is designed to address a specific business function and includes all required software, implementation services, training and documentation. These packages can be combined and built upon over time to address growing compliance requirements.

Pharmaceutical dashboard and reporting solution

The QUMAS dashboard and reporting solution, QUMAS Compliance Unity, provides detailed business intelligence and delivers an integrated view of your enterprise’s compliance activities. Access to all information is in real time and individual dashboard and scorecards can be created according to each individual user’s requirements. Features include:

• Tailored company-specific view of compliance: analyze by your organizational taxonomy – product, category, location, etc.
• Drill-down to actionable compliance data for investigation, remediation and planning of proactive compliance initiatives based on real-time data
• Secure-role based access to your dashboard from a web browser, providing 24/7 access to your critical compliance data
• Simple-to-create custom reporting provides specific views across your organization, as well as out-of-the box reports

The MyQUMAS solution enables users to access functionality in all QUMAS solutions through a user-friendly interface that provides all compliance content and tasks in one view. MyQUMAS provides a single point of access from which users can monitor their areas of responsibility and perform specific tasks across compliance initiatives. It is a simple, intuitive user interface with the ability to create multiple limited views based on roles and permissions, simplifying and reducing the costs of regulatory compliance management. Only the functionality users require is accessible to them, reducing training and maintenance requirements.

Core features of QUMAS compliance software

QUMAS functionality includes:

• Role-based electronic signatures – ensures the meaning of electronic signatures match user intent (21 CFR Part 11)
• Workflow and configuration management – allows users to map their unique business processes to the system without customization
• Advanced lifecycle management – convenient access to all document lifecycles
• Automated notification and distribution – enables effective distribution and rapid notification of document changes and approvals
• Read and Understood – provides traceable accountability throughout the organization
• Comprehensive, independent audit trail – captures more than 300 auditable events, allowing export or printing for regulatory agency review

The QUMAS SDK facilitates integration with a wide variety of third-party systems, including ERP, LIMS, LMS, and so on.