Pharmaceuticals & Biotechnology
Discovery how SoftExpert can revolutionize management in your company!
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.
- Promote traceability and adherence to regulatory best practices such as FDA 21 CFR Part 11, with automated EBR reports.
- Implement Statistical Process Control (SPC) with real-time checks, linking deviations to Nonconformity/CAPA.
- Streamline Product Quality Review (PQR) through simplified data collection and analysis.
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.
