The solution enables pharmaceutical and biotechnology organizations to map, analyze and continually improve the efficiency of operations by integrating them in a single platform of different management frameworks, including product design, regulatory affairs, adverse events, change management, electronic batch records (EBR), and supplier management, among others.
Get to know each one:
Asset Management
Change Management
Clinical Research
Complaint Management
Eletronic Records
Pharmacovigilance
Product Development
Processes
Quality
Quality Control
Regulatory Affairs
Risk Management
SoftExpert Suite
Supplier Management
Increase asset availability, lifespan, and reliability. Accurately control of equipment and instruments, with a solution that meets international standards such as ISO 50001, ISO 55000 and ISO 17025. Create comprehensive calibration and maintenance plans. Take advantage of real-time monitoring features and smart alerts. Perform preventive maintenance, to minimize risks of failures and unscheduled shutdowns. Ensure regulatory compliance, increase team productivity, reduce waste, and make strategic decisions based on reliable data.
- Asset registration, control and tracking
- Management of preventive, predictive and corrective maintenance
- Programming and execution of activities
- Calibration and verification management
- Work order management
- Document management
- Materials and resource management
- Inventory management
- Failure analysis and continuous improvement
- Reporting and analytics
Streamline and have control over the entire change process, from request to final implementation. Ensure compliance with pharmaceutical industry regulations and standards. Track and control all steps, documents, and approvals with transparency and efficiency. Increase team productivity, reduce errors and risks, and drive continuous process improvement.
- Record of change requests
- Change approval management
- Evaluation of the change by the responsible areas
- Management of implementation actions
- Monitoring and evaluation of effectiveness
- Change history and tracking
- Document management
- Efficacy assessment
- Reporting and analytics
Streamline every step of the clinical research process, from participant recruitment and selection to data collection and analysis, with advanced management and monitoring capabilities. The SoftExpert Suite provides greater accuracy, efficiency, regulatory compliance and integrity of the data collected, allowing researchers to focus on what really matters: making significant advances in healthcare and improving people’s lives. Increase your team’s productivity, reduce errors and eliminate paper with SoftExpert’s digital solution.
- Study planning and management
- Registration of participants
- Case report forms
- Results collection
- Visit management
- Document and data management
- Quality event management
- Activity management
- Reporting and data analysis
Increase customer satisfaction with SoftExpert’s complaint management solution. Automate the process of registering, tracking, and resolving complaints to comply with pharmaceutical industry regulations. Facilitate data monitoring and analysis by identifying trends and opportunities for improvement to enhance the quality of products and services. Ensure regulatory compliance and enhance your company’s reputation by providing quality customer service.
- Complaints and Returns Management
- Investigation and handling of complaints
- Corrective action management
- Monitoring complaints
- Integration with service channels
- Document and evidence management
- Control of deadlines and automatic notifications
- Customer data security
- Reporting and data analysis
Stop wasting time with manual and disorganized processes. Streamline your processes and keep your records organized and secure. Advanced data management capabilities give you complete control over critical pharmaceutical documentation, such as quality and production records, regulatory compliance, batch tracking, and more, to ensure the quality and safety of your products. Centralize all relevant information in one place, making it easy for team members to access and collaborate. Furthermore, SoftExpert Suite offers powerful search and filter tools that allow you to quickly find the records you need, saving you time and effort.
- Electronic records management
- Document management
- Process control
- Automated workflow
- Information traceability
- Version control and change histories
- Data integrity
- Regulatory compliance
- Reporting and analytics
Ensure the safety of medication, closely monitor efficacy, potential side effects and drug interactions, and ensure the quality and reliability of your products. Increase transparency and agility in monitoring adverse event reports by simplifying communication with regulatory authorities. Proactively identify trends and risks, preserving patient health and enhancing your company’s reputation.
- Recording of reports and adverse events
- Case Management
- Integration with Medra dictionary
- E2B R3 functionality
- Automatic causality calculation (Naranjo algorithm)
- Alerts and notifications
- Management of corrective and preventive actions
Improve your product development process and make the medication development and launch process faster, safer, and more cost-effective. With advanced project management, document control, collaboration, and data analysis capabilities, you’ll have all the tools you need to accelerate medication discovery, development, and launch. Automate repetitive tasks, eliminate errors, and ensure regulatory compliance and product safety. Increase staff productivity, reduce development time, and bring your innovative medication to market faster.
- Bill of Materials Management (BOM)
- Document management
- Change Control
- Design Control
- Quality by Design (QbD)
- Design History File (DHF)
- Project management
- Risk Management
- Problem management
Streamline and automate all phases of your pharmaceutical processes, from manufacturing to distribution of medication. Gain agility, efficiency, and accuracy in your operations. Gain full control over production management, quality, documentation, and more. Simplify strategic decision making with accurate analysis and reporting. With SoftExpert Suite, you can benefit from a transparent workflow, reduce costs and errors, and ensure compliance with all pharmaceutical industry standards and regulations.
- Traceability
- Automated workflow
- Manufacturing process management
- Monitoring deadlines and scheduling tasks
- Information and document management
- Compliance with regulations
- Audit and compliance
- Data analysis and reporting
Streamline quality and efficiency in the pharmaceutical industry with SoftExpert Suite. Designed specifically to meet the industry’s stringent regulatory requirements, the solution provides a comprehensive, automated approach to meeting Good Manufacturing Practice (GMP) guidelines and local and international regulations. Strictly control all stages of the production chain, from the arrival of raw materials to final packaging, ensuring batch traceability, regulatory compliance, quality control, and the integrity and safety of your products. With advanced automation, document management, training, and auditing capabilities, we ensure compliance with the most stringent industry requirements and standards, enhancing your product reliability and patient safety. Stay ahead of the curve by identifying and resolving problems, increasing productivity, reducing risk, and maintaining your company’s impeccable reputation.
- Document management
- Training management
- Management of quality deviations
- CAPA
- Audit management
- Statistical Process Control
- Reporting and Analytics
Streamline your quality control processes to ensure regulatory compliance and product safety. Track and manage all steps, from receipt of raw materials to final release, with complete traceability and accurate documentation. Increase efficiency, reduce errors and costs, comply with required standards and regulations, and achieve superior results at every stage of the production process.
- Document management
- Change control
- Management of non-conformities
- Risk monitoring
- Calibration and maintenance control
- Customer Complaint Management
- Batch traceability
- Reporting and data analysis
Streamline your project submission process by accelerating new medication approvals and reducing the risk of non-compliance. Save time and stay ahead of the competition with the most complete and reliable solution for pharmaceutical regulatory affairs. Ensure compliance, simplify the management of all documentation and regulations required for medication manufacturing, and provide a robust framework for regulatory compliance.
- Product data management
- Dossier management
- Deadline and activity management
- Security and access control
- Process monitoring
- History and traceability
- Indexing and organization of data and documents
- Integration with other systems
- Reporting and analytics
Identify, assess, control and manage the risks associated with your operations. Maximize security, reliability, and compliance, optimize your time, reduce costs, and make proactive, informed decisions. Minimize potential problems and increase the safety and efficacy of your products.
- Risk identification and assessment
- Action planning
- Risk control and mitigation
- Monitoring and review of risks
- Incident and deviation management
- Document management
- Communication and documentation of risks
- Reporting and analytics
SoftExpert Suite is the most comprehensive solution to collaboratively solve critical business excellence challenges into an integrated multi-application environment.
SoftExpert offers an integrated suite of components that can be implemented as business demands grow and the need to incorporate new functions.
Whatever the strategy chosen, only a fully shared Business Excellence environment allows its applications fit together like puzzle pieces and work seamlessly
Manage your suppliers efficiently and securely. Simplify the entire process from supplier selection, evaluation, and qualification to monitoring, auditing, quality control, and performance. Reduce costs, improve quality, increase productivity, and mitigate risk. Ensure safety and compliance with industry standards and regulations such as Anvisa, FDA, and EMA, in addition to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Clinical Practices (GCP).
With advanced features, you’ll be able to carry out:
- Supplier registration and information management
- Supplier qualification
- Document management
- Audit management
- Supplier quality inspection
- Contract management and quality agreements
- Management of non-conformities
- Risk management
- Performance management
A single solution with the best benefits for your company!
Get to know each one:
Increase asset availability, lifespan, and reliability. Accurately control of equipment and instruments, with a solution that meets international standards such as ISO 50001, ISO 55000 and ISO 17025. Create comprehensive calibration and maintenance plans. Take advantage of real-time monitoring features and smart alerts. Perform preventive maintenance, to minimize risks of failures and unscheduled shutdowns. Ensure regulatory compliance, increase team productivity, reduce waste, and make strategic decisions based on reliable data.
- Asset registration, control and tracking
- Management of preventive, predictive and corrective maintenance
- Programming and execution of activities
- Calibration and verification management
- Work order management
- Document management
- Materials and resource management
- Inventory management
- Failure analysis and continuous improvement
- Reporting and analytics
Streamline and have control over the entire change process, from request to final implementation. Ensure compliance with pharmaceutical industry regulations and standards. Track and control all steps, documents, and approvals with transparency and efficiency. Increase team productivity, reduce errors and risks, and drive continuous process improvement.
- Record of change requests
- Change approval management
- Evaluation of the change by the responsible areas
- Management of implementation actions
- Monitoring and evaluation of effectiveness
- Change history and tracking
- Document management
- Efficacy assessment
- Reporting and analytics
Streamline every step of the clinical research process, from participant recruitment and selection to data collection and analysis, with advanced management and monitoring capabilities. The SoftExpert Suite provides greater accuracy, efficiency, regulatory compliance and integrity of the data collected, allowing researchers to focus on what really matters: making significant advances in healthcare and improving people’s lives. Increase your team’s productivity, reduce errors and eliminate paper with SoftExpert’s digital solution.
- Study planning and management
- Registration of participants
- Case report forms
- Results collection
- Visit management
- Document and data management
- Quality event management
- Activity management
- Reporting and data analysis
Increase customer satisfaction with SoftExpert’s complaint management solution. Automate the process of registering, tracking, and resolving complaints to comply with pharmaceutical industry regulations. Facilitate data monitoring and analysis by identifying trends and opportunities for improvement to enhance the quality of products and services. Ensure regulatory compliance and enhance your company’s reputation by providing quality customer service.
- Complaints and Returns Management
- Investigation and handling of complaints
- Corrective action management
- Monitoring complaints
- Integration with service channels
- Document and evidence management
- Control of deadlines and automatic notifications
- Customer data security
- Reporting and data analysis
Stop wasting time with manual and disorganized processes. Streamline your processes and keep your records organized and secure. Advanced data management capabilities give you complete control over critical pharmaceutical documentation, such as quality and production records, regulatory compliance, batch tracking, and more, to ensure the quality and safety of your products. Centralize all relevant information in one place, making it easy for team members to access and collaborate. Furthermore, SoftExpert Suite offers powerful search and filter tools that allow you to quickly find the records you need, saving you time and effort.
- Electronic records management
- Document management
- Process control
- Automated workflow
- Information traceability
- Version control and change histories
- Data integrity
- Regulatory compliance
- Reporting and analytics
Ensure the safety of medication, closely monitor efficacy, potential side effects and drug interactions, and ensure the quality and reliability of your products. Increase transparency and agility in monitoring adverse event reports by simplifying communication with regulatory authorities. Proactively identify trends and risks, preserving patient health and enhancing your company’s reputation.
- Recording of reports and adverse events
- Case Management
- Integration with Medra dictionary
- E2B R3 functionality
- Automatic causality calculation (Naranjo algorithm)
- Alerts and notifications
- Management of corrective and preventive actions
Improve your product development process and make the medication development and launch process faster, safer, and more cost-effective. With advanced project management, document control, collaboration, and data analysis capabilities, you’ll have all the tools you need to accelerate medication discovery, development, and launch. Automate repetitive tasks, eliminate errors, and ensure regulatory compliance and product safety. Increase staff productivity, reduce development time, and bring your innovative medication to market faster.
- Bill of Materials Management (BOM)
- Document management
- Change Control
- Design Control
- Quality by Design (QbD)
- Design History File (DHF)
- Project management
- Risk Management
- Problem management
Streamline and automate all phases of your pharmaceutical processes, from manufacturing to distribution of medication. Gain agility, efficiency, and accuracy in your operations. Gain full control over production management, quality, documentation, and more. Simplify strategic decision making with accurate analysis and reporting. With SoftExpert Suite, you can benefit from a transparent workflow, reduce costs and errors, and ensure compliance with all pharmaceutical industry standards and regulations.
- Traceability
- Automated workflow
- Manufacturing process management
- Monitoring deadlines and scheduling tasks
- Information and document management
- Compliance with regulations
- Audit and compliance
- Data analysis and reporting
Streamline quality and efficiency in the pharmaceutical industry with SoftExpert Suite. Designed specifically to meet the industry’s stringent regulatory requirements, the solution provides a comprehensive, automated approach to meeting Good Manufacturing Practice (GMP) guidelines and local and international regulations. Strictly control all stages of the production chain, from the arrival of raw materials to final packaging, ensuring batch traceability, regulatory compliance, quality control, and the integrity and safety of your products. With advanced automation, document management, training, and auditing capabilities, we ensure compliance with the most stringent industry requirements and standards, enhancing your product reliability and patient safety. Stay ahead of the curve by identifying and resolving problems, increasing productivity, reducing risk, and maintaining your company’s impeccable reputation.
- Document management
- Training management
- Management of quality deviations
- CAPA
- Audit management
- Statistical Process Control
- Reporting and Analytics
Streamline your quality control processes to ensure regulatory compliance and product safety. Track and manage all steps, from receipt of raw materials to final release, with complete traceability and accurate documentation. Increase efficiency, reduce errors and costs, comply with required standards and regulations, and achieve superior results at every stage of the production process.
- Document management
- Change control
- Management of non-conformities
- Risk monitoring
- Calibration and maintenance control
- Customer Complaint Management
- Batch traceability
- Reporting and data analysis
Streamline your project submission process by accelerating new medication approvals and reducing the risk of non-compliance. Save time and stay ahead of the competition with the most complete and reliable solution for pharmaceutical regulatory affairs. Ensure compliance, simplify the management of all documentation and regulations required for medication manufacturing, and provide a robust framework for regulatory compliance.
- Product data management
- Dossier management
- Deadline and activity management
- Security and access control
- Process monitoring
- History and traceability
- Indexing and organization of data and documents
- Integration with other systems
- Reporting and analytics
Identify, assess, control and manage the risks associated with your operations. Maximize security, reliability, and compliance, optimize your time, reduce costs, and make proactive, informed decisions. Minimize potential problems and increase the safety and efficacy of your products.
- Risk identification and assessment
- Action planning
- Risk control and mitigation
- Monitoring and review of risks
- Incident and deviation management
- Document management
- Communication and documentation of risks
- Reporting and analytics
SoftExpert Suite is the most comprehensive solution to collaboratively solve critical business excellence challenges into an integrated multi-application environment.
SoftExpert offers an integrated suite of components that can be implemented as business demands grow and the need to incorporate new functions.
Whatever the strategy chosen, only a fully shared Business Excellence environment allows its applications fit together like puzzle pieces and work seamlessly
Manage your suppliers efficiently and securely. Simplify the entire process from supplier selection, evaluation, and qualification to monitoring, auditing, quality control, and performance. Reduce costs, improve quality, increase productivity, and mitigate risk. Ensure safety and compliance with industry standards and regulations such as Anvisa, FDA, and EMA, in addition to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and Good Clinical Practices (GCP).
With advanced features, you’ll be able to carry out:
- Supplier registration and information management
- Supplier qualification
- Document management
- Audit management
- Supplier quality inspection
- Contract management and quality agreements
- Management of non-conformities
- Risk management
- Performance management
Discover some Success Stories
Hypofarma integrates ERP with SoftExpert Suite and advances digital transformation
Pharlab gains agility and security by digitalizing processes with SoftExpert Suite
SoftExpert solutions provide compliance, agility and productivity to the pharmaceutical company BIOMM
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