BI Platform Solutions
BIcosmos is a comprehensive platform designed to address critical business needs all-in-one platform with modules for
End-to-End Digital Transformation
BIcosmos provides integrated solutions that seamlessly manage critical processes such as:
Quality Management: Seamless workflows for document control, risk management, Change management, Nonconformance, CAPA and more
E-Log Management: Digital logs to replace manual entries, ensuring data integrity and compliance.
Inventory Management: Real-time tracking of inventory levels, stock alerts, and usage reports.
Preventive Maintenance (PM): Automated scheduling, tracking, and execution of maintenance activities for equipment and assets.
Audit Management: Tailored workflows for regulatory and client audits with integrated dashboards.
Vendor Management: Streamlined processes for onboarding, risk assessment, and performance tracking.
With BIcosmos, organizations can achieve digital transformation without requiring multiple fragmented tools.
BIcosmos QMS: Transforming Quality Management with Intelligent Tools
At BIcosmos, our Quality Management System (QMS) is designed to empower businesses to achieve excellence through seamless management of key processes like Change Management, Non-Conformance (NC), Corrective and Preventive Actions (CAPA), Market Complaint and more quality events. With BIcosmos, you don’t just manage quality; you leverage data-driven insights to drive continuous improvement and ensure compliance at every step.
Regulatory Compliance and Standards
Our solution is designed with regulatory compliance in mind, ensuring that all complaint management processes meet the standards set by industry regulations such as FDA, EMA, and ISO 13485. BIcosmos ensures that all complaints are logged, tracked, and resolved in a way that aligns with the latest quality standards, preventing potential regulatory issues and ensuring product quality.
Flexible and Compliant Workflows
We understand that each organization has unique needs. That’s why BIcosmos offers both customized workflows tailored to your specific requirements and standardized workflows that meet industry best practices. Regardless of the approach you choose, all workflows are built to ensure regulatory compliance, helping your organization stay aligned with the latest industry standards and requirements.
BIP Change Management
BIcosmos helps streamline the Change Management process, ensuring that every change is tracked, assessed, and implemented effectively. Our system supports a structured approach to managing changes, from initial request to final approval. By providing real-time visibility into the status and impact of changes, BIcosmos ensures that your organization adapts quickly while maintaining operational integrity.
How BIcosmos Manages Change Control
- Change Request Logging: Change requests are logged into the system, where they are categorized based on type (e.g., process changes, material changes, software updates) and impact (e.g., minor, major, critical).
- Impact Assessment: BIcosmos allows for the automatic assessment of changes, considering their potential impact on product quality, regulatory requirements, and operational processes. This helps prioritize the most critical changes while ensuring compliance.
- Approval Workflow: Once the change is assessed, it moves through a customizable approval workflow where stakeholders, including subject matter experts, quality assurance, and regulatory teams, can review and approve the proposed change.
- Implementation and Documentation: After approval, the change is implemented, and all related actions, including training, updates to procedures, and documentation, are tracked to ensure proper execution and compliance with industry regulations.
BIP Non-Conformance (NC) Management
Non-conformance events are inevitable, but how you handle them is crucial. BIcosmos helps you manage NCs with a comprehensive solution that tracks the lifecycle of each incident—from identification to resolution. By automating the NC workflow, our system ensures faster identification, analysis, and correction of non-conformance issues, reducing the risk of recurrence and improving product quality.
How BIcosmos Manages Non-Conformance
- NC Detection and Logging: Non-conformance events are captured in real-time through automated systems, ensuring immediate logging of issues as they arise. Whether the issue is product-related, process-related, or external, our system ensures it is categorized for effective resolution.
- Investigation and Root Cause Analysis: Once logged, BIcosmos provides the tools to investigate the root cause of the non-conformance. Our system integrates data analytics to identify trends and patterns, helping uncover underlying causes that might not be immediately visible.
- Corrective and Preventive Actions (CAPA): After the root cause is identified, BIcosmos automatically triggers corrective actions to resolve the immediate issue and preventive actions to address the systemic problems, ensuring that the issue does not recur.
BIP Corrective and Preventive Actions (CAPA)
Our BI-powered CAPA module goes beyond simply tracking actions—it helps you identify the underlying causes of quality issues and implement sustainable solutions. Whether you’re addressing a corrective action to prevent recurrence or a preventive action to avoid future risks, BIcosmos ensures that each CAPA is executed thoroughly and effectively.
How BIcosmos Manages CAPA
- CAPA Initiation: The process begins when a non-conformance (NC) or a market complaint triggers the need for corrective or preventive action. The system automatically captures and categorizes the issue, initiating the CAPA workflow.
- Root Cause Analysis: BIcosmos provides tools for conducting a thorough root cause analysis using data-driven methods. Our system integrates advanced analytics and trend analysis to help your team identify the underlying causes, whether related to process, product, or human factors.
- Corrective Action: Once the root cause is determined, BIcosmos enables the creation and implementation of corrective actions that address the immediate issue. These actions are tracked within the system, ensuring that they are executed in a timely manner and that their effectiveness is validated.
- Preventive Action: To prevent the recurrence of similar issues, preventive actions are implemented. These actions aim to improve systems, processes, or controls to mitigate future risks. BIcosmos helps you develop and track preventive measures, ensuring that all preventive actions are fully documented and compliant.
- Verification and Closure: The effectiveness of both corrective and preventive actions is continuously monitored, and once it is confirmed that the issue is resolved and measures are in place to prevent recurrence, the CAPA is closed.
Market Complaint Management with BIcosmos
Our Market Complaint Management process goes beyond simple tracking. With BIcosmos, complaints are logged in real time, allowing your team to act swiftly. Our system ensures that complaints are captured, categorized, and tracked through a clear, structured process, minimizing delays and facilitating quick resolutions.
How BIcosmos Manages Market Complaints
- Complaint Intake and Categorization: Complaints are logged in the system, automatically categorized by severity, type (e.g., quality issue, delivery error), and origin (e.g., customer, distributor, regulatory body).
- Root Cause Investigation: Once a complaint is logged, BIcosmos helps you perform a detailed root cause analysis, allowing you to identify systemic issues and underlying problems. Our system integrates data analytics to uncover patterns, helping your team focus on the most critical issues.
- Corrective Action: After the root cause is identified, the system generates corrective actions aimed at eliminating the issue. BIcosmos allows you to track the execution of corrective measures in real time, ensuring they are applied quickly and effectively to resolve the complaint.
- Preventive Action: To prevent future occurrences, BIcosmos supports preventive actions, helping you address underlying systemic problems before they affect customers again. This proactive approach helps safeguard your business from recurring complaint
Are you seeing recurring QMS events tied to a specific process? With BIcosmos’s BI QMS, you can track and trend data points to uncover insights that highlight strategic opportunities for continuous improvement. By incorporating predictive quality management analytics into your decision-making process, you gain intelligence that helps mitigate risks, such as manufacturing defects, customer complaints, and operational inefficiencies.
Harness the power of data to proactively reduce operational and corporate risks, ensuring a more resilient and compliant quality management system across your organization.
Stop depending on IT for reporting and data analysis. With BIcosmos’s BI Platform, you can easily drill into your quality system data, filter relevant information, and uncover hidden trends that may go unnoticed. Whether starting with pre-built dashboards or creating custom analyses from scratch, you have the flexibility to pull data points directly from your quality management records.
Access your quality analysis anytime, anywhere, including directly from your mobile device. Whether you're on the manufacturing floor or meeting with an auditor, BIcosmos ensures you always have the insights you need at your fingertips.
With vast amounts of data in your quality management system, BIcosmos's BI Platform transforms this data into actionable analytics and insights. Our platform helps you visualize your quality processes across your global enterprise, providing a clear view from individual sites and departments to a unified global perspective.
Leveraging intelligent data quality management tools, we simplify the process of monitoring your quality performance in real time. With BIcosmos, you gain the clarity needed to make informed decisions, drive continuous improvements, and ensure that quality standards are consistently met across your organization.
BI Risk Management
BI Risk Management
Enhancing Risk Management with BIcosmos: 3D Risk and Risk Registry
Effective risk management is essential in today’s fast-paced business environment. BIcosmos’s BI Risk Management solution offers cutting-edge tools, including 3D Risk analysis and a centralized Risk Registry, to help organizations identify, assess, and mitigate risks proactively.
3D Risk: A Comprehensive Approach to Risk Assessment
With BIcosmos’s 3D Risk framework, risks are analyzed from three essential dimensions: Severity, Likelihood, and Impact. This holistic approach enables you to:
- Evaluate Risks from Multiple Perspectives: Gain a deeper understanding of each risk by considering its operational, resource, and strategic impact.
- Prioritize Effectively: Combine all three dimensions to assess and prioritize risks based on their potential impact, ensuring the most critical risks are addressed first.
- Make Informed Decisions: Empower decision-makers with more precise risk profiles, enabling them to implement focused mitigation strategies and reduce overall risk exposure.
Risk Registry: Streamlined Risk Tracking and Management
The BIcosmos Risk Registry serves as a centralized repository where all identified risks are recorded, tracked, and managed. Key features include:
- Centralized Risk Documentation: Store and manage all risk-related information in an organized manner, including severity, likelihood, impact, and mitigation actions.
- Monitor Risk Mitigation Progress: Track the status of risk mitigation efforts and assess the effectiveness of these actions in real time.
- Enable Real-Time Monitoring: Receive proactive alerts for emerging risks, allowing for swift intervention before risks escalate into significant issues.
- Ensure Regulatory Compliance: Maintain a well-documented risk registry that helps meet industry regulations, audit requirements, and reporting standards.
Benefits of BIcosmos Risk Management
- Proactive Risk Mitigation: Leverage the 3D Risk model and Risk Registry to identify and address potential risks before they affect your organization.
- Real-Time Insights: Stay ahead of threats with continuous risk monitoring and actionable insights into your risk landscape.
- Centralized Risk Tracking: Simplify risk management by having all your risks documented and tracked in one platform, making it easier to manage and report.
- Enhanced Compliance: Stay compliant with internal and external regulations by keeping accurate records and reporting on risk management efforts.
BI Asset Management
BI Asset Management
How Does BI Assest Management Help Businesses?
Experience greater flexibility in managing maintenance activities for your critical assets and resources with the BIcosmos Platform.
With BI Assest Management, you can:- Create an Asset and Criteria Library: Build and maintain a comprehensive library of assets and associated criteria for more efficient management.
- Manage Maintenance Schedules: Plan and track maintenance schedules to ensure timely upkeep of critical equipment.
- Perform Scheduled/Unscheduled Maintenance: Easily manage both scheduled and unscheduled maintenance tasks to minimize downtime.
- Alert Equipment Owners for Maintenance: Quickly notify equipment owners about upcoming maintenance activities to ensure timely action.
- Gain Improved Visibility of Equipment Performance: Monitor real-time performance data to identify and address potential issues proactively.
- Integrate with Nonconformance Management: Seamlessly connect your maintenance management system with the Nonconformance Management System for better tracking and resolution of issues
- Create an Asset and Criteria Library: Build and maintain a comprehensive library of assets and associated criteria for more efficient management.
- Manage Maintenance Schedules: Plan and track maintenance schedules to ensure timely upkeep of critical equipment.
- Perform Scheduled/Unscheduled Maintenance: Easily manage both scheduled and unscheduled maintenance tasks to minimize downtime.
- Alert Equipment Owners for Maintenance: Quickly notify equipment owners about upcoming maintenance activities to ensure timely action.
- Gain Improved Visibility of Equipment Performance: Monitor real-time performance data to identify and address potential issues proactively.
- Integrate with Nonconformance Management: Seamlessly connect your maintenance management system with the Nonconformance Management System for better tracking and resolution of issues
To know on other module in BI Platform reach by dropping us an email support@bicosmos.com