TrackWise Digital is a cloud-based Quality Management System designed for regulated industries, including pharmaceuticals, biotechnology, medical devices, and consumer health products. The platform supports end-to-end quality processes through configurable modules, including:

• QUALITY MANAGEMENT 

  - Nonconformances and deviations management along with associated trends, investigations, approvals and resulting records

  - Integrated Corrective and preventive action (CAPA) system with automated routing, notification, delivery,

  escalation and approval capabilities

  - Change Control Management to manages changes from request, through pre-approvals, change execution, follow-up approvals and implementation

  - Audit Management

• COMPLAINT MANAGEMENT

• DOCUMENT MANAGEMENT

• TRAINING MANAGEMENT

• INTEGRATED RISK MANAGEMENT

• SUPPLIER QUALITY MANAGEMENT

 Licensing & Subscription Model

TrackWise Digital is offered through a subscription-based licensing model with Named User Licenses

Deployment Options

Cloud (SaaS)

• Fully managed and validated cloud environment using Salesforce platform

• Automatic updates and maintenance
• Lower infrastructure requirements
• Faster deployment

Validation & Regulatory Compliance

TrackWise Digital supports compliance with major pharmaceutical and life science regulations, including:

• FDA 21 CFR Part 11
• EU GMP Annex 11
• GAMP 5 principles
• ALCOA+ data integrity requirements
• Electronic Signatures
• Audit Trails
• Access Controls and Role-Based Security
• Change History Tracking
• Event Logging and Traceability

Technical Architecture & Integration

TrackWise provides extensive integration capabilities, including:

• REST APIs and Web Services
• Oracle ERP
• SAP ERP
• Microsoft Active Directory
• Single Sign-On (SSO)
• Laboratory Information Management Systems (LIMS)
• MES Systems
• Learning Management Systems (LMS)
• Third-Party Business Applications