Product Summary

Managing supplier audits and third-party risk through spreadsheets and disconnected processes often leads to compliance gaps, delayed audits, and poor visibility. smartData developed Pharma TPR, a centralized web platform that digitizes the complete supplier audit lifecycle—from onboarding and audit planning to findings management, CAPA tracking, and regulatory documentation. The solution provides secure role-based access for administrators, auditors, and suppliers while streamlining collaboration and maintaining complete audit traceability. Automated workflows, document management, and compliance reporting reduce manual effort, accelerate audit execution, and strengthen regulatory preparedness for pharmaceutical organizations.

Features

• Audit Management: Schedule, assign, and monitor supplier audits through configurable workflows.
• Supplier Portal: Secure workspace for document sharing, evidence submission, and audit collaboration.
• Audit Execution & Findings: Capture observations, record findings, and maintain end-to-end audit traceability.
• CAPA Management: Track corrective and preventive actions from initiation through verification and closure.
• Regulatory Documentation: Generate FDA-compliant forms and maintain complete compliance records.

Technical Challenges

• Managing complex multi-stage audit workflows involving suppliers, auditors, CAPA reviews, and compliance approvals. : Implemented configurable workflow engines with status-driven transitions, automated notifications, and role-based approvals.
• Maintaining complete traceability across documents, findings, CAPA actions, and regulatory records. : Designed centralized audit history with document versioning, activity logging, and end-to-end audit trails.
• Protecting sensitive compliance and supplier information across multiple user roles. : Implemented JWT authentication, role-based access control, secure document management, and permission-based visibility.