Life Science and Pharmaceuticals
SoftExpert Suite is the cloud-based solution with AI to optimize BPx and support regulatory compliance across the industry.
Aligned with ANVISA, FDA, and EMA guidelines, it provides traceability and continuous monitoring from R&D to post-market activities. Integrates with ERP systems for centralized and efficient management across operational areas.
Optimize your path to GxP excellence
Up to 80% reduction in the time spent on managing documents such as Quality Manual, SOPs, and Work Instructions.
Up to 50% increase in productivity by efficiently managing GxP actions, promoting user adoption and ensuring required action plans are completed by all areas.
Up to 50% reduction in time spent on inspections and audits, providing greater agility and reducing manual work.
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.
Learn More About the SoftExpert QMS Solution →
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.
Use cases
Learn how SoftExpert helps companies in the pharmaceutical and life sciences industries
Recognition
SoftExpert Achieves AWS Life Sciences Competency
SoftExpert proudly achieves the AWS Life Sciences Competency, reinforcing its leadership in delivering secure and innovative solutions for pharmaceutical and life sciences industries. Through integration with AWS, our clients eliminate recurring costs associated with internal application support, covering hardware and software updates, security administration, data backups, infrastructure redundancies, and internal support. This milestone solidifies SoftExpert as a key partner for excellence and innovation in the life sciences sector.
Bring this solution to your company
Ensure compliance with the following standards and regulations
Learn more about SoftExpert's solutions
Compliance with global privacy and security standards
Advanced data protection
SoftExpert ensures the protection of your company's data and compliance with the requirements of the latest standards.
Integrate with your ERP, CRM, Office365, and much more
Connect SoftExpert Suite to other business tools already used in your organization.
Worldwide Office Locations
Supporting and implementing your growth and expasion everywhere! We are present locally, ready to ensure that SoftExpert solutions are working without limits.
Customize the solution to your needs
Add new modules to your product, customize your experience and get all the solutions you need for your company.
An award-winning platform recognized by customers
