Revolutionizing eQMS: AI-Driven Excellence in Quality Management
Explore Acteria eQMS
Introducing a Game-Changer in Quality Management
Welcome to the future of Quality Management Systems (QMS) with Acteria's eQMS. Our cutting-edge electronic Quality Management System is designed to meet the diverse needs of modern businesses, offering unparalleled efficiency, compliance, and user-friendly interfaces. It's not just a product; it's your partner in excellence.
Why Choose eQMS?
Comprehensive Compliance: Our eQMS is meticulously designed to align with global regulatory standards, ensuring your business remains compliant with ISO, FDA, and EMA guidelines. It's a tool that grows with you, adapting to evolving regulations and industry standards.
Seamless Integration: We understand the complexity of existing systems. Our eQMS seamlessly integrates with your current IT infrastructure, enhancing operational flow without the typical integration hassles.
Data-Driven Decision Making: With advanced analytics and real-time data access, eQMS turns data into actionable insights. Empower your decision-makers with the right information at the right time.
Scalability and Flexibility: Whether you're a startup or a multinational corporation, eQMS scales to fit your unique needs. Our flexible architecture supports your growth, ensuring that your quality management capabilities grow with your business.
Enhanced Productivity and Efficiency: Automate routine tasks, reduce manual errors, and accelerate your processes. eQMS streamlines operations, freeing up valuable resources to focus on core business activities.
User-Centric Design: We prioritize user experience. Our intuitive interface is easy to navigate, reducing training time and increasing user adoption rates.
Welcome to the future of Quality Management Systems (QMS) with Acteria's eQMS. Our cutting-edge electronic Quality Management System is designed to meet the diverse needs of modern businesses, offering unparalleled efficiency, compliance, and user-friendly interfaces. It's not just a product; it's your partner in excellence.
Why Choose eQMS?
Comprehensive Compliance: Our eQMS is meticulously designed to align with global regulatory standards, ensuring your business remains compliant with ISO, FDA, and EMA guidelines. It's a tool that grows with you, adapting to evolving regulations and industry standards.
Seamless Integration: We understand the complexity of existing systems. Our eQMS seamlessly integrates with your current IT infrastructure, enhancing operational flow without the typical integration hassles.
Data-Driven Decision Making: With advanced analytics and real-time data access, eQMS turns data into actionable insights. Empower your decision-makers with the right information at the right time.
Scalability and Flexibility: Whether you're a startup or a multinational corporation, eQMS scales to fit your unique needs. Our flexible architecture supports your growth, ensuring that your quality management capabilities grow with your business.
Enhanced Productivity and Efficiency: Automate routine tasks, reduce manual errors, and accelerate your processes. eQMS streamlines operations, freeing up valuable resources to focus on core business activities.
User-Centric Design: We prioritize user experience. Our intuitive interface is easy to navigate, reducing training time and increasing user adoption rates.
Product Overview
Documentation Center
Training Center
CAPA, Deviation, Change Control
Customer Complaint
Batch Records
Get to Know Acteria eQMS
Acteria Documentation Center
Electronic Signatures and Audit Trails: These features are crucial for compliance with FDA 21 CFR Part 11, which sets the criteria under which electronic records and electronic signatures are considered trustworthy, reliable, and equivalent to paper records.
Version Control: Is essential for managing document revisions and history, ensuring that only the current version of a document is accessible. This is a requirement under various regulations like SOX, ISO 9001, and others.
Standard Operating Procedures (SOPs) Management: SOPs are integral to compliance with FDA regulations and ISO standards, making their creation, review, approval, and distribution a priority within a DMS.
Comprehensive Document Security: This encompasses access controls and protection against unauthorized modification or deletion, fulfilling requirements of HIPAA and GDPR.
Automated Workflow Management: Streamlining processes such as approval, review, and change control to enhance efficiency and compliance.
Version Control: Is essential for managing document revisions and history, ensuring that only the current version of a document is accessible. This is a requirement under various regulations like SOX, ISO 9001, and others.
Standard Operating Procedures (SOPs) Management: SOPs are integral to compliance with FDA regulations and ISO standards, making their creation, review, approval, and distribution a priority within a DMS.
Comprehensive Document Security: This encompasses access controls and protection against unauthorized modification or deletion, fulfilling requirements of HIPAA and GDPR.
Automated Workflow Management: Streamlining processes such as approval, review, and change control to enhance efficiency and compliance.
Quality Processes
CAPA (Corrective and Preventive Actions): Tackle non-conformances head-on with our intuitive CAPA system, designed to identify, track, and manage remedial actions effectively.
Deviation Management: Navigate through unexpected events with a structured approach that records, classifies, and analyses deviations, facilitating a prompt return to standard operational procedures.
Change Control: Implement changes with precision and control. Our change management process is comprehensive, providing a clear and auditable trail from request to approval and implementation.
Customer Complaints: Handle customer feedback with care and efficiency. Our process not only addresses and resolves customer issues but also harnesses this input to drive continuous improvement.
Deviation Management: Navigate through unexpected events with a structured approach that records, classifies, and analyses deviations, facilitating a prompt return to standard operational procedures.
Change Control: Implement changes with precision and control. Our change management process is comprehensive, providing a clear and auditable trail from request to approval and implementation.
Customer Complaints: Handle customer feedback with care and efficiency. Our process not only addresses and resolves customer issues but also harnesses this input to drive continuous improvement.
Batch Record
Digital Batch Records: Replace paper-based batch records with a digital system that provides real-time data capture, ensuring accuracy and traceability throughout the production cycle.
Automated Workflow Management: Streamline batch operations with automated workflows that guide operators through each step, reducing errors and ensuring compliance with predefined process parameters.
Integrated Quality Checks: Incorporate quality control within batch operations, prompting mandatory checks and tests at critical stages to ensure product quality and compliance.
Real-Time Monitoring and Alerts: Monitor batch production in real-time with alerts that notify relevant personnel of deviations or non-conformances, allowing for immediate corrective action.
Electronic Signatures and Audit Trails: Maintain a secure and compliant system with electronic signatures for verification and a comprehensive audit trail for every batch record.
Seamless Scalability: Flexibly scale batch operations to meet production demands without compromising compliance or control, thanks to a robust and scalable infrastructure.
Data-Driven Decision Making: Utilize the power of data analytics to gain insights into batch trends, process efficiencies, and areas for improvement, supporting informed decision-making.
Regulatory Compliance Assurance: Designed to meet the stringent requirements of regulatory bodies, ensuring that each batch record complies with industry standards such as FDA 21 CFR Part 11.
Customizable Templates: Tailor batch records to specific products or processes with customizable templates that can be adjusted to meet unique operational needs.
Revision Control: Keep track of changes with revision control, ensuring that only the most current and approved batch record versions are in use.
Automated Workflow Management: Streamline batch operations with automated workflows that guide operators through each step, reducing errors and ensuring compliance with predefined process parameters.
Integrated Quality Checks: Incorporate quality control within batch operations, prompting mandatory checks and tests at critical stages to ensure product quality and compliance.
Real-Time Monitoring and Alerts: Monitor batch production in real-time with alerts that notify relevant personnel of deviations or non-conformances, allowing for immediate corrective action.
Electronic Signatures and Audit Trails: Maintain a secure and compliant system with electronic signatures for verification and a comprehensive audit trail for every batch record.
Seamless Scalability: Flexibly scale batch operations to meet production demands without compromising compliance or control, thanks to a robust and scalable infrastructure.
Data-Driven Decision Making: Utilize the power of data analytics to gain insights into batch trends, process efficiencies, and areas for improvement, supporting informed decision-making.
Regulatory Compliance Assurance: Designed to meet the stringent requirements of regulatory bodies, ensuring that each batch record complies with industry standards such as FDA 21 CFR Part 11.
Customizable Templates: Tailor batch records to specific products or processes with customizable templates that can be adjusted to meet unique operational needs.
Revision Control: Keep track of changes with revision control, ensuring that only the most current and approved batch record versions are in use.
Training Center
Role-Based Training Matrices: Organize and track employee training specific to their roles, ensuring everyone is qualified for their specific responsibilities.
Automated Training Tasks: Simplify the assignment and tracking of training to guarantee timely completion and adherence to compliance standards.
Integrated Document and Training Compliance: Seamlessly manage and link important documents with training tasks, providing a transparent compliance status.
Blended Learning Curricula: Support multiple learning methods, including digital and classroom settings, to cater to diverse learning preferences.
Dynamic Dashboards & Reports: Access real-time insights into training progress and compliance metrics with customizable dashboards.
Automated Training Tasks: Simplify the assignment and tracking of training to guarantee timely completion and adherence to compliance standards.
Integrated Document and Training Compliance: Seamlessly manage and link important documents with training tasks, providing a transparent compliance status.
Blended Learning Curricula: Support multiple learning methods, including digital and classroom settings, to cater to diverse learning preferences.
Dynamic Dashboards & Reports: Access real-time insights into training progress and compliance metrics with customizable dashboards.
Customer Complaint
Intuitive Complaint Intake: Our system provides an easy-to-use interface for the recording and tracking of customer complaints, ensuring that every voice is heard and acted upon.
Automated Triage: Leveraging AI, the module automatically categorizes complaints based on severity, impact, and type, directing them to appropriate teams for prompt action.
Comprehensive Investigation Workflow: Facilitates a systematic approach to investigating each complaint, from initial assessment to root cause analysis, leveraging AI to suggest potential causes and corrective actions.
Direct Customer Feedback Loop: Incorporates mechanisms for direct communication with customers, keeping them informed of the status of their complaint and actions taken, fostering trust and transparency.
Integrated Corrective Actions: Seamlessly connects with the CAPA module to initiate corrective and preventive actions where necessary, ensuring that resolutions are not just reactive but proactive.
Data-Driven Insights: Employs advanced analytics to extract trends and patterns from complaints, providing strategic insights into product and service improvements.
Regulatory Compliance: Ensures that all customer complaint processes are in compliance with global regulatory standards, including documentation, reporting, and resolution requirements.
Automated Triage: Leveraging AI, the module automatically categorizes complaints based on severity, impact, and type, directing them to appropriate teams for prompt action.
Comprehensive Investigation Workflow: Facilitates a systematic approach to investigating each complaint, from initial assessment to root cause analysis, leveraging AI to suggest potential causes and corrective actions.
Direct Customer Feedback Loop: Incorporates mechanisms for direct communication with customers, keeping them informed of the status of their complaint and actions taken, fostering trust and transparency.
Integrated Corrective Actions: Seamlessly connects with the CAPA module to initiate corrective and preventive actions where necessary, ensuring that resolutions are not just reactive but proactive.
Data-Driven Insights: Employs advanced analytics to extract trends and patterns from complaints, providing strategic insights into product and service improvements.
Regulatory Compliance: Ensures that all customer complaint processes are in compliance with global regulatory standards, including documentation, reporting, and resolution requirements.
+1 (914) 357-4033
447 Broadway, New York, NY, New York, US, 10013
.svg)
+1 (914) 357-4033
447 Broadway, New York, NY, New York, US, 10013