Life Science and Pharmaceuticals

SoftExpert Suite is a complete, validated, AI-powered cloud solution designed for the Life Science and Pharmaceuticals Industry. It streamlines critical GxP processes, ensures compliance with FDA and EMA, and provides total traceability with real-time control - from R&D through post-market surveillance. Its integration with ERP systems enables even more efficient and centralized management, connecting all critical operational areas.

Learn how to automate and optimize quality processes for the Pharmaceutical Industry

Unified QMS for Comprehensive GxP Management

• Automate Change Control, Nonconformances, and Customer Complaints with efficient workflows and action plans. 

• Systematize Supplier Management & Qualification, integrating documents and actions for seamless oversight and collaboration. 

• Implement Robust Document Revision Control linked to mandatory training, ensuring compliant personnel. 

• Utilize Intuitive Tools for CAPA and Risk Management, promoting collaborative and effective problem-solving. 

• Ensure Integrated Internal & External Audit Readiness with total traceability for regulatory audits. 

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Achieve GMP Excellence on the Production Floor

• Digitize and Customize Electronic Batch Records (EBR), ensuring strict process adherence. 

• Ensure precise traceability and compliance (GxP, 21 CFR Part 11) with automated reports from EBR. 

• Implement Statistical Process Control (SPC) with real-time checks, linking deviations to Nonconformity/CAPA. 

• Facilitate Product Quality Review (PQR) via automated data collection and simplified analysis. 

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Integrated Product Lifecycle Management:  From R&D to Post–Market Surveillance

• Integrate teams, documents, data, and systems into one platform. 

• Ensure your pharmaceutical products reach the market on time, and within budget. 

• Manage Global Regulatory Submissions & Registrations, supporting ICH M4 CTD/eCTD format for consistency. 

• Optimize Adverse Event (AE) Reporting and Processing with integrated coding, causality assessment, and compliant workflows. 

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