Your Questions, Answered
Continuous Intelligent Validation (cIV)
The definition: "Continuous validation is providing documented evidence to certify that an app not only met the pre-established acceptance criteria, but “continuous” to meet thus mitigating the risk of unknown changes."
Continuous validation is not just a "point in time" validation. It is a type of validation which connects various points in time (initial, patch, upgrade validation) with continuous smoke and regression testing. This feature provides the documented evidence that the an app worked well not just at discrete points in time in the past, but continues to function as expected in the present. This also mitigates the risk of any change in either the IaaS/PaaS layer (for cloud apps) or the underlying IT infrastructure (for on-prem apps) that can potentially alter its behavior.
xLM's QMS is based on industry standards as well as applicable GxPs. xLM's QMS is a robust framework based on ISO 9001:2015, GAMP 5 and ASTM E2500 as well as FDA 21 CFR Part 11, EudraLex Annex 11. xLM's QMS enables us to deliver our managed services that not only meets, but exceeds the expectations of regulatory agencies in the USA, Europe and Japan.
cIV is an AI-powered continuous validation platform that aims to revolutionize software validation by introducing autonomous agents that can generate an URS, develop test cases and execute them with very minimal human input. It employs advanced AI algorithms to enhance test coverage, reduce false positives and negatives while adapting to application changes. The platform automates the entire Software Development Life Cycle (SDLC), from generating User Requirements Specifications (URS) to executing tests, thereby minimizing manual effort and increasing reliability. cIV is organized into three (3) distinct modules: URS Generation, Test Case Generation, and Test Automation - all accessible via the browser.
cIV leverages advanced language models to automate the creation of User Requirements Specifications (URS), generate detailed test cases, and produce Test Plan Execution (TPE) reports. cIV is built on xLM’s Continuous Intelligence platform. The input can be as simple as an user manual. Our agents can navigate the System Under Test (SUT) leveraging its auto exploration capabilties. The accuracy of the output can be further increased by simply walking thru test case scenarios using the built-in recorder function. The above inputs are catalogued into a knowledge graph which forms the basis for the agents to build the artifacts.
Step 1: Autogeneration of the knowledgebase by cIV agents: Inputs - URS Template, Software User Manuals, Manual Test Cases (if available), auto exploration of the SUT
Step 2: cIV Agent-1 generates the URS in minutes. Human-in-the-loop should be used to refine/approve the URS.
Step 3: cIV Agent-2 takes the approved URS and generates detailed test cases. It ensures coverage of the requirements to fullfil the traceability.
Step 4: cIV Agent-3 Executes the test cases and delivers a GxP compliant TPE in PDF format.
Leveraging advanced language models and Retrieval-Augmented Generation (RAG) technology, cIV delivers exceptional User Requirement Specification (URS) documentation. The system combines sophisticated AI capabilities with vector databases to accomplish two critical objectives: retrieving pertinent information and transforming it into meticulously structured, GxP-compliant specifications. This innovative automation not only ensures consistency across documents but also significantly reduces human error while capturing all user requirements with precision and thoroughness.
After URS validation, cIV streamlines the requirements management process through sophisticated AI-driven tools that effectively categorize and consolidate specifications. The system then transforms these consolidated requirements into comprehensive test cases, structured in both BDD and web-action formats.
Leveraging its robust knowledge repository and specialized information extractors, the platform systematically generates a step by step test cases to fulfill the corresponding requiremetns. This methodical approach ensures thorough test coverage while maintaining precise alignment with user expectations and requirements.
The cIV Test Automation Module streamlines test execution through sophisticated parsing of uploaded test cases and seamless interaction with the System Under Test (SUT). Leveraging advanced cross-browser testing tools, it meticulously validates application behavior while generating comprehensive, GxP-compliant Test Plan Execution (TPE) reports. Through its agentic framework, the module ensures exceptional precision and operational efficiency throughout the entire testing lifecycle.
cIV demonstrates exceptional future-readiness through its sophisticated AI-driven architecture. The platform dynamically adapts to evolving application environments, consistently maintaining precision in User Requirement Specifications (URS), test cases, and automation scripts. This inherent adaptability establishes cIV as a powerful and sustainable solution for long-term software validation needs. During the execution step, the test automation code is dynamically generated based on the current SUT and does not rely upon any pre-generated code.
Continuous Document Management (cDM)
ContinuousDM is a state-of-the-art Document Management (DM) application specifically designed for life science companies working in GxP-regulated environments. It addresses the common challenges associated with traditional DM systems, such as:
Scalability Issues: Traditional DM systems often struggle to scale with growing data volumes and user demands.
Poor User Experience: Outdated technology and unfriendly user interfaces lead to frustration and low adoption rates.
Limited Collaboration: Lack of real-time collaboration features hinders teamwork and slows down document review processes.
Compliance Concerns: Ensuring 21 CFR Part 11 compliance can be complex and time-consuming with traditional systems.
ContinuousDM overcomes these challenges by offering a scalable, user-friendly platform with robust collaboration tools and built-in compliance features.
ContinuousDM offers significant advantages over managing documents in Word, including:
Real-Time Collaboration: Multiple users can simultaneously edit the same document, eliminating version control issues and fostering efficient teamwork.
Centralized Information: All documents are stored in a single repository, ensuring everyone accesses the latest version and reducing confusion.
Enhanced Version Control and Audit Trails: Every change is tracked and logged, ensuring accountability, transparency, and compliance with regulatory requirements.
Powerful Search Capabilities: Finding specific documents is quick and easy, thanks to advanced search filters and indexing.
Unlimited Extensibility: Integration with numerous apps and extensions provides a comprehensive document management solution.
ContinuousDM integrates AI in several ways to improve efficiency and user experience:
AI-Powered Summaries: Quickly grasp the key points of lengthy documents with automated summaries.
Smart Links: Gain insights and context without leaving the current document by previewing linked content.
Intelligent Search: AI algorithms refine search results, ensuring users find the most relevant information quickly.
Yes, ContinuousDM offers extensive customization options to adapt to various workflows:
Custom Workflows: Design workflows tailored to your organization's processes, including defining stages, roles, permissions, and automated actions.
Document Classification: Categorize documents based on sensitivity levels to ensure proper handling and access control.
Space-Level Permissions: Control access to specific areas within ContinuousDM, granting different permissions to users and groups.
ContinuousDM prioritizes data security with features like:
Encryption and Decryption: Data is encrypted both in transit and at rest, protecting it from unauthorized access.
User Permissions and Groups: Access to sensitive information is restricted to authorized personnel based on their roles and clearance levels.
Secrets Management: Securely store and manage sensitive information, including passwords, credentials, and license keys.
Compliance with Industry Standards: ContinuousDM is designed to meet the stringent requirements of 21 CFR Part 11 for electronic records and signatures.
ContinuousDM facilitates seamless collaboration through features like:
Real-Time Co-Authoring: Multiple users can edit documents concurrently, streamlining teamwork and reducing bottlenecks.
Comments and Discussions: Users can add comments, tag colleagues, and engage in discussions directly within documents, fostering efficient feedback loops.
Whiteboards: Digital whiteboards provide a shared space for brainstorming, idea visualization, and collaborative planning.
ContinuousDM offers seamless integration with popular productivity and communication tools, including:
Microsoft Teams and Slack: Streamline communication and document sharing within these platforms.
Google Drive and Microsoft 365: Access and edit files stored in these cloud services directly from ContinuousDM.
Various Marketplace Apps: Extend functionality further with numerous apps available in the Atlassian Marketplace.
ContinuousDM is delivered as a managed service, meaning:
Rapid Deployment: You can be up and running on the same day with minimal setup effort.
Continuous Validation: The system undergoes continuous validation, ensuring ongoing compliance with GxP regulations.
No Validation Burden: You don't need to worry about managing validation documents or executing test protocols.
Expert Support: The service includes ongoing support from xLM experts to assist with any questions or issues.
Continuous Predictive Maintenance (cPdM)
ContinuousPdM: ContinuousPdM represents a groundbreaking advancement in predictive maintenance technology, seamlessly combining sophisticated data analytics, machine learning algorithms, and real-time monitoring capabilities. This innovative approach transforms traditional maintenance paradigms by replacing reactive measures with proactive strategies, ultimately leading to significant improvements in both equipment reliability and operational efficiency.
Step 1: Industrial sensors continuously track critical operational parameters, including vibration levels, temperature fluctuations, and pressure readings. This comprehensive monitoring system streams collected data to a centralized platform, enabling immediate analysis and actionable insights in real-time.
Step 2: Leveraging a secure cloud infrastructure, the system processes data to develop sophisticated predictive models that accurately anticipate equipment failures and proactively identify maintenance requirements.
Step 3: GxP-compliant dashboards deliver comprehensive business intelligence through actionable insights, detailed analytical reports, and robust audit-ready documentation, ensuring regulatory compliance while streamlining operational oversight.
Through this innovative strategy, organizations can significantly reduce unplanned downtime while maximizing asset utilization and enhancing overall operational productivity.
ContinuousPdM harnesses sophisticated machine learning technologies, specifically Isolation Forests and Long Short-Term Memory (LSTM) networks, to revolutionize predictive maintenance. These cutting-edge models perform three critical functions:
Advanced anomaly detection within sensor data streams.
Accurate prediction of equipment failure patterns.
Data-driven maintenance schedule optimization through actionable insights.
Through its dual capability of processing both historical trends and real-time operational data, ContinuousPdM delivers highly accurate predictive analytics. This precision enables maintenance teams to implement targeted interventions at optimal times, significantly boosting operational efficiency while extending equipment lifespan.
Key Benefits:
Reduced Downtime: Sophisticated monitoring systems proactively detect potential issues, preventing unexpected equipment failures.
Optimized Maintenance: Strategic scheduling of maintenance activities during planned downtimes minimizes operational disruptions and maximizes productivity.
Cost Savings: Intelligent resource management eliminates unnecessary maintenance procedures while optimizing spare parts inventory levels.
Improved Compliance: Comprehensive audit trails and GxP-compliant dashboards ensure regulatory adherence and streamlined reporting.
This data-driven approach not only enhances manufacturing efficiency but also drives sustainable profitability through smarter asset management and reduced operational costs.
Continuous Predictive Maintenance (cPdM) leverages Reinforcement Learning (RL) technology to significantly improve maintenance forecasting accuracy. This advanced approach continuously refines its predictive models through systematic feedback loops, enabling increasingly precise maintenance recommendations over time. Here's how it works:
Feedback Loop Integration: Reinforcement Learning (RL) improves decision-making by incorporating real-world maintenance outcomes into its framework. Analyzing results like reduced equipment downtime and cost savings, the model refines its predictive accuracy and strategic recommendations, leading to a more adaptive maintenance solution.
Dynamic Adaptation: Reinforcement Learning (RL) shows great adaptability by analyzing and responding to changing operational and sensor data patterns. This capability ensures the model remains effective despite fluctuations in equipment conditions and evolving usage patterns throughout its lifecycle.
Optimal Decision-Making: Through advanced reinforcement learning (RL), maintenance strategies are optimized by analyzing scenarios that balance risk management (including unexpected equipment failures) and cost optimization (like avoiding premature repairs). This approach leads to more accurate maintenance scheduling, enhancing operational reliability while minimizing costs.
Improved Pattern Recognition: Reinforcement Learning (RL) excels at analyzing complex relationships among variables like vibration, temperature, and load conditions. This advanced analytical ability allows the model to detect subtle patterns and correlations that traditional static algorithms often miss.
Continuous Improvement: Reinforcement Learning (RL) refines predictive accuracy iteratively, adapting to new data while aligning current operations with historical performance patterns.
Through Reinforcement Learning (RL), predictive maintenance systems evolve into adaptive solutions with high accuracy. This approach reduces equipment downtime, optimizes costs, and extends industrial machinery's service life.
Continuous Temperature Mapping (cTM)
cTM is a service designed for the MedTech, Biotech, and Pharma sectors that offers continuous temperature mapping through automation, data handling, and machine learning. It streamlines the temperature mapping process by automating everything from data collection to dashboard presentation with almost negligible human effort.
Step 1: Calibrated RF dataloggers are placed in their mapping locations and linked to a gateway via the guest wireless network. These loggers can measure Temperature, RH.
Step 2: Data automatically flows into xLM’s validated cloud. User can log into xLM’s Intelligent Portal, specify some basic parameters and upload the data from the fixed BMS sensors. cTM automatically generates all the dashboards needed to validate the mapping study.
Step 3: User can download GxP compliant reports in PDF format to attach them to the summary report.
cTM employs data transformation techniques to convert raw data into a readable format standardizing information the dataloggers. The process includes data pre-processing with normalization methods like min-max scaling and z-score normalization, along with feature engineering to extract valuable insights from the data. Machine learning models facilitate predictive analytics for forecasting temperature trends and detecting anomalies, utilizing algorithms such as Isolation Forests and Local Outlier Factor.
cTM provides three types of dashboards, each serving a specific purpose:
Temporary Sensors Dashboard: Designed for comprehensive analysis of NFC and RF datalogger information, this tool specializes in short-term data mapping. The software offers three essential capabilities: sophisticated deviation analysis, intuitive timeline visualization, and statistical T-test comparisons. These features enable users to effectively monitor, analyze, and interpret temporal data patterns.
Fixed Sensors Dashboard: Utilizing data from permanently installed sensors, this dashboard delivers comprehensive thermal analysis, temperature pattern monitoring, and advanced visual tools designed for efficient anomaly detection and diagnosis.
Sensor Mapping Dashboard: This dashboard includes analysis of data by comparing readings between fixed and temporary sensor installations. Through proximity-based clustering and detailed deviation graphs, it delivers comprehensive environmental surveillance and performance tracking.
cTM offers numerous advantages to streamline operations in highly regulated environments:
Time Savings: Automated processes streamline operations by eliminating the need for manual data logging and reporting, resulting in enhanced efficiency and reduced human intervention.
Error Reduction: Machine Learning technology revolutionizes temperature mapping by significantly improving data accuracy and substantially reducing measurement errors. This advanced computational approach ensures more precise and reliable mapping analysis results..
Scalability: Highly adaptable and versatile, cTM seamlessly integrates into warehouses of all sizes, effectively managing even the most complex storage environments.
Proactive Monitoring: Predictive analytics empowers organizations to implement proactive measures, enabling timely interventions that prevent potential deviations before they occur..
Continuous Application Lifecycle Management (cALM)
ContinuousALM is a comprehensive Application Lifecycle Management (ALM) platform designed specifically for the life sciences industry. It moves beyond traditional document-centric approaches, providing a centralized hub for managing all aspects of software development and validation.
Key features include:
Complete Application Life Cycle Management: Manage requirements, specifications, test cases (manual and automated), traceability, deviations, and more in one platform.
System Under Test (SUT) Management: Organize and manage SUTs, whether they are hardware, equipment, or software components.
Coverage by Requirements, Specifications, and Tests: Gain insights into coverage levels with adjustable percentages and priority-based specification weighting.
Requirements and Specifications Management: Easily manage requirements within the platform or integrate with external systems like JIRA and VersionOne.
Requirement Risk Management: Assign risk levels to requirements, streamlining reporting and prioritizing tests based on risk assessment.
Test Management: Organize tests efficiently with structured folders, API-specific organization, and support for various test types.
Test Campaign Management: Effortlessly organize, execute, and evaluate test campaigns with insights into campaign quality and session success.
Defect (Deviation, Discrepancy) Management: Centralized defect repository with real-time status updates, severity and priority ratings, and integration with test case analysis.
Compliance with Part 11: Comprehensive support for 21 CFR Part 11 requirements, including audit trails, role-based security, version control, e-signatures, and more.
Traceability, Transformed: Seamless bi-directional traceability between requirements, specifications, tests, and defects, ensuring comprehensive documentation and transparency.
Built-in Support for Part 11 Compliance: Features like object freezing, versioning, and audit trails ensure compliance with regulatory requirements.
Integration Features: Connect with a wide range of tools, including JIRA, Quality Center, Mantis, and various CI tools like Bamboo and Jenkins.
Reporting Redefined: Generate comprehensive reports on system functionality, test results, compliance status, risk mitigation, and more.
Software Quality Built-in: Support for automated and manual testing, exploratory testing, test case parameterization, real-time execution tracking, and more.
ContinuousALM - Delivered as a Managed Service: Continuously qualified software and continuously validated customer instances ensure reliability and compliance.
Traditional reliance on MS Word and Excel for managing validation and software lifecycles presents several challenges:
Lack of Centralization: Documents scattered across various locations lead to version control issues and difficulty in tracking progress.
Limited Traceability: Connecting requirements, specifications, tests, and defects across disparate documents is cumbersome and prone to errors.
Manual Processes: Heavily reliant on manual documentation, review, and execution, which increases the risk of human error and delays.
Compliance Challenges: Ensuring Part 11 compliance with manual document-based systems is time-consuming and requires extensive documentation.
ContinuousALM addresses these limitations by:
Providing a centralized platform: All lifecycle artifacts are managed within the system, eliminating scattered documents and improving version control.
Enabling seamless traceability: Bi-directional traceability features connect all elements, providing a clear audit trail and ensuring compliance.
Automating processes: Automated test execution, report generation, and other features streamline workflows and reduce manual effort.
Built-in Part 11 compliance: Features like audit trails, e-signatures, and object freezing simplify compliance and reduce the risk of regulatory issues.
SUT Management in ContinuousALM allows you to effectively organize and manage all your Systems Under Test (SUTs). Each SUT, whether it's a hardware device, a piece of equipment, or a software component, is clearly identified by its name and version.
This is crucial because it:
Ensures Clarity: Clear identification prevents confusion and errors during testing.
Provides Structure: SUTs are organized within a hierarchy of companies, folders, and sub-folders, making them easy to locate and manage.
Facilitates Comprehensive Testing: A well-defined SUT inventory ensures all components are accounted for and thoroughly tested.
ContinuousALM features a dedicated risk management module that allows users to assign a risk level to each requirement. This risk level is calculated based on the probability of failure and the potential impact of that failure on the functionality.
Risk management is essential because it:
Prioritizes Testing Efforts: By focusing on high-risk requirements, teams can ensure that critical areas are thoroughly tested.
Improves Resource Allocation: Resources can be directed towards mitigating high-risk areas, optimizing efficiency and effectiveness.
Enhances Decision-Making: Risk assessments provide valuable information for making informed decisions about development and validation activities.
ContinuousALM's Test Management module provides several advantages:
Structured Organization: Tests are organized in folders, making it easy to manage and locate specific tests.
API-Specific Organization: For software APIs, tests are organized per function/method, facilitating test suite extension and specialized testing.
Comprehensive Test Coverage: Support for various test types ensures thorough testing, including functional, stress, and negative testing.
Automated Test Execution: Integrates with various automation frameworks, streamlining test execution and reducing manual effort.
Real-Time Test Tracking: Track test execution progress in real time, providing immediate insights into test results.
ContinuousALM is designed with built-in features to meet the stringent requirements of FDA 21 CFR Part 11. Key compliance features include:
Audit Trails: Detailed audit logs track all changes made to the system, ensuring accountability and transparency.
Role-Based Security: Granular access controls restrict actions based on user roles, preventing unauthorized modifications.
Version Control: All objects are version controlled, allowing for easy tracking of changes and rollbacks to previous versions.
E-Signatures: Electronic signatures provide secure and verifiable approval processes, ensuring data integrity.
Object Freezing: Critical objects can be frozen to prevent further modifications, ensuring data integrity and compliance.
ContinuousALM offers advanced reporting capabilities that provide valuable insights for decision-making and compliance:
Comprehensive Reports: Generate detailed reports on various aspects of the lifecycle, including system functionality, test results, compliance status, and risk assessments.
Customizable Templates: Reports can be generated using customizable templates to align with company branding and specific reporting requirements.
Real-Time Data Visualization: Visual dashboards provide real-time insights into project progress, test coverage, and quality metrics.
Export Options: Reports can be exported in various formats (XML, HTML, CSV, Word, PDF) for easy sharing and integration with other systems.
Compliance Documentation: Effortlessly generate documentation required for regulatory submissions, such as URS, Test Plans, and Traceability Matrices.
ContinuousALM is committed to ongoing innovation, and AI is playing an increasingly significant role. Planned AI features include:
Automated Test Case Generation: AI will generate test cases automatically from exploratory testing sessions, saving time and improving test coverage.
Intelligent Traceability Validation: AI algorithms will validate traceability, ensuring accuracy and completeness of links between requirements, specifications, tests, and defects.
AI-Driven Test Selection: An AI agent will determine the most relevant tests to run based on code changes, optimizing testing efficiency and reducing redundant efforts.
These AI features are designed to further enhance ContinuousALM's capabilities, automate manual processes, and empower life sciences companies to achieve higher levels of efficiency, quality, and compliance.
Continuous Remote Monitoring & Management (cRMM)
ContinuousRMM is a cloud-based remote monitoring and management (RMM) solution built on the Atera platform. It's designed specifically for life science companies of all sizes, especially small to medium-sized businesses (SMBs), to manage and secure their IT assets, both GxP and non-GxP, while ensuring compliance.
ContinuousRMM is designed with GxP compliance in mind. Key features that support compliance include:
Continuous Qualification & Validation: The software and your instance are continuously qualified and validated, ensuring compliance over time.
Audit Logs: Provides uneditable system-level logs of technician activity, acting as an audit trail for compliance and transparency.
Security Features: Offers robust security measures like real-time monitoring, patch management, endpoint protection, and network security to protect sensitive GxP data.
ContinuousRMM offers a wide array of benefits, including:
Proactive IT Management: Real-time monitoring, alerts, and automated maintenance tasks prevent issues before they impact operations.
Enhanced Security: Comprehensive security features protect against threats, ensuring data integrity and system stability.
Streamlined IT Operations: Automation, scripting, and a centralized dashboard simplify IT management, saving time and resources.
Improved Compliance: Features like audit logs and robust security measures contribute to maintaining GxP compliance.
ContinuousRMM streamlines IT operations by:
Automating Tasks: Routine tasks like patch management, software deployment, and system maintenance can be automated, freeing up IT staff.
Centralized Management: Manage all IT assets from a single dashboard, providing a comprehensive view of the entire infrastructure.
AI-Powered Features: AI assists in ticket analysis, script generation, and ticket tagging, allowing faster resolution and efficient resource allocation.
Yes, ContinuousRMM integrates with a wide range of software solutions, including:
Security Solutions: Antivirus, antimalware, intrusion detection, and prevention systems.
Backup Solutions: Leading backup and disaster recovery providers.
Remote Access Solutions: Enable secure remote access for troubleshooting and support.
Network Monitoring Tools: Comprehensive network performance and security monitoring.
The Shared Script Library is a repository of pre-built scripts contributed by the ContinuousRMM community. You can leverage these scripts to:
Automate Tasks: Find scripts for common IT tasks, saving time and effort in scripting from scratch.
Troubleshoot Issues: Access proven scripts for troubleshooting specific issues, speeding up resolution time.
Share Your Expertise: Contribute your own scripts to the library, helping others and fostering community knowledge.
ContinuousRMM leverages AI in various ways:
AI-Powered Script Generation: AI drafts scripts based on ticket content, reducing manual scripting efforts.
Automated Ticket Analysis and Resolution: AI analyzes tickets to suggest solutions, automate responses, and categorize tickets for efficient routing.
AI Ticket Tagging: Automatically tags tickets based on keywords, ensuring they reach the right technician quickly.
ContinuousRMM offers comprehensive reporting and analytics on:
Device Health & Performance: CPU usage, memory consumption, disk space, etc.
Network Status: Network traffic, bandwidth usage, device availability.
Security Posture: Patch compliance, security alerts, threat detection.
User Activity: Logged-in users, access attempts, application usage.
Continuous Service Management (cSM)
ContinuousSM is a comprehensive, AI-powered service management solution designed to help life sciences companies streamline processes, improve efficiency, and maintain GxP compliance. It's built on the Atlassian platform and delivered as a managed service, meaning it's continuously validated and requires minimal setup time.
ContinuousSM provides a centralized platform for capturing, tracking, and managing requests from various channels. It allows for automated workflows with approvals, customizable queues, and insightful performance reports, enabling teams to optimize resource allocation and identify bottlenecks.
ContinuousSM's Asset Management goes beyond traditional CMDBs, offering a flexible structure for managing any asset type. It helps track asset lifecycles, ownership, and validation status. This enables informed decision-making, proactive impact analysis for changes, and faster incident resolution.
ContinuousSM streamlines change management with automated change requests, risk assessment tools, and integration with ContinuousDM for collaborative change planning. This allows teams to accelerate approvals for low-risk changes, while ensuring thorough review and documentation for high-risk changes.
ContinuousSM leverages AI for various tasks, including:
Virtual Agent: Provides automated, conversational support through Slack, answering questions and resolving basic requests, freeing up human agents for more complex issues.
AI-Powered Insights: Analyzes data to identify patterns and generate actionable insights, improving decision-making for service optimization.
ContinuousSM is offered as a managed service. This means the application is continuously qualified, and each customer's instance is continuously validated. This eliminates the need for extensive validation documentation and testing on the customer side, allowing for rapid deployment and assured compliance.
ContinuousSM offers a centralized knowledge base with powerful search functionalities, including machine learning-powered relevance and federated search across various content types. This, combined with the AI-powered virtual agent, enables efficient self-service, deflecting common requests and empowering users to find answers quickly.
Continuous Risk Management (cRM)
Continuous Risk Management (ContinuousRM) is a comprehensive approach to proactively identifying, assessing, and mitigating risks throughout the entire lifecycle of a project or process. This method goes beyond traditional risk management by emphasizing ongoing monitoring, analysis, and adaptation to changing risk landscapes.
Traditional Risk Management often fails due to:
Lack of integration: It's treated as a separate activity rather than an integral part of the project lifecycle.
Paper-based exercises: Risk assessments are frequently performed as check-the-box activities with no real impact on decision-making.
Inadequate tools: Lack of user-friendly tools makes creating, managing, and tracking risks difficult, hindering effective implementation.
ContinuousRM is critical in the life sciences industry due to stringent regulatory requirements and the impact of risks on patient safety. It helps organizations:
Ensure regulatory compliance: By adhering to standards like GMP, GLP, and GCP.
Maintain business continuity: Proactive risk mitigation minimizes disruptions to manufacturing and supply chains.
Facilitate audits and inspections: Provides a centralized repository for risk-related documents, streamlining audits.
Enhance product quality: Identifying and addressing risks throughout the product lifecycle ensures consistent quality and reduces defects and recalls.
ContinuousRM offers features like:
Customizable risk tables: Provides a spreadsheet-like view for easy visualization and management of risks.
Custom risk models: Allows tailoring risk matrices and scoring mechanisms to specific organizational needs and risk appetites.
Risk identification, mitigation, verification, and traceability: Enables a systematic approach to managing risks throughout the project lifecycle.
Risk reporting: Generates comprehensive reports with insights into risk assessments, mitigation strategies, and overall risk status.
ContinuousRM integrates risks with mitigation actions, requirements, tests, and other relevant project elements. This interconnectedness ensures complete traceability of:
Risk origin and evolution: Understanding how risks emerge and change over time.
Mitigation measures: Tracking the actions taken to address identified risks.
Verification of mitigation efforts: Confirming the effectiveness of implemented mitigation strategies.
The Risk Matrix is a visual tool that helps assess and prioritize risks based on their likelihood and potential impact. ContinuousRM enables:
Customization of parameters: Define risk levels and scoring mechanisms to align with organizational needs.
Automatic risk score calculation: Provides a clear visualization of risk severity and facilitates prioritization.
Improved communication and collaboration: Offers an easy-to-understand representation of risks for stakeholders.
ContinuousRM offers predefined report templates and customizable options for comprehensive risk reporting:
Risk Matrix Macro: Presents initial and residual risks in a matrix format, adjustable to specific preferences.
Risk Table Macro: Displays risks in a structured table view, linking risks to mitigation actions and verification tasks.
Risk History Report: Provides a historical overview of individual risks with customizable parameters and timelines.
ContinuousRM offers several advantages:
Proactive risk management: Enables organizations to anticipate and address risks before they escalate.
Improved decision-making: Provides data-driven insights for informed decision-making across project phases.
Enhanced communication and collaboration: Facilitates a shared understanding of risks among stakeholders.
Increased efficiency and compliance: Streamlines risk management processes and ensures adherence to industry standards.
Continuous Managed Threat Response (cMTR)
ContinuousMTR is a Cybersecurity-as-a-Service solution specifically designed for drug and device manufacturers. It provides comprehensive protection against a wide range of cyber threats, including ransomware attacks, data breaches, insider threats, and supply chain vulnerabilities. The service is delivered and managed by xLM in partnership with Sophos, leveraging advanced security technologies and 24/7 expert support.
Industry 4.0 and the adoption of smart factories have expanded the attack surface for manufacturers due to increased digital transformation and IT/OT convergence. This exposes them to higher risks of cyberattacks, production sabotage, and intellectual property theft. ContinuousMTR addresses these challenges through:
Managed Detection and Response (MDR): 24/7 monitoring and response to sophisticated cyberattacks.
Zero Trust Network Access (ZTNA): Secure access control to critical systems and data, verifying every user and device.
Endpoint Protection with Intercept X: Proactive threat detection and prevention using AI and other advanced technologies.
Extended Detection and Response (XDR): Comprehensive visibility across the entire security environment for faster threat detection and response.
Supply Chain Attack Mitigation: Security measures to protect against vulnerabilities that can infiltrate through third-party suppliers.
ContinuousMTR offers numerous benefits to drug and device manufacturers, including:
Reduced Business Risk Exposure: Minimizes the likelihood and impact of successful cyberattacks.
Increased Data Integrity Compliance: Helps meet FDA data integrity mandates and other regulatory requirements.
Enhanced Protection for Critical Assets: Safeguards intellectual property, manufacturing processes, and sensitive data.
Proactive Threat Detection and Response: Identifies and neutralizes threats before they can cause significant damage.
24/7 Expert Support: Access to a team of cybersecurity specialists who can assist with incident response and other security needs.
Compliance with Industry Standards: Aligns with GxP, HIPAA, PCI DSS, GDPR, and other relevant regulations.
ContinuousMTR uses a Zero Trust Network Access (ZTNA) approach, which operates on the principle of "trust nothing, verify everything." This means that every user and device attempting to access critical systems and data must be continuously validated. ZTNA ensures that only authorized users and devices with a proven health status can connect, minimizing the risk of unauthorized access and lateral movement of threats.
ContinuousMTR incorporates features to mitigate insider threats through:
User-Based Access and Controls: Granular control over user access to specific resources and data.
User Risk Visibility: Identifies and monitors risky users based on behavior patterns and threat history.
Data Loss Prevention: Prevents sensitive data from leaving the organization's control, whether intentionally or accidentally.
Intercept X is an advanced endpoint protection solution that utilizes deep learning, anti-exploit, anti-ransomware, and malicious traffic detection to proactively defend against a wide range of threats. It constantly learns and improves, providing robust protection for endpoints within the ContinuousMTR framework.
Yes, ContinuousMTR helps organizations meet the stringent cyber control requirements often imposed by insurance providers. By providing comprehensive cybersecurity measures such as 24/7 endpoint detection and response, web security, logging and monitoring, ContinuousMTR demonstrates a strong security posture that can satisfy insurance conditions and potentially reduce premiums.
ContinuousMTR is a fully managed service, meaning that xLM and Sophos provide ongoing support, including:
24/7/365 Security Monitoring and Incident Response: A dedicated team of experts continuously monitors the environment and responds to security events and incidents.
Proactive Threat Hunting: Experts actively search for potential threats that may bypass traditional security measures.
Security Consulting and Guidance: Assistance with developing and implementing security strategies, policies, and best practices.
Software and Infrastructure Management: Continuous updates and maintenance of the security software and infrastructure.
Continuous Mail Protector (cMP)
Email is a critical communication tool in GxP environments, even if not always a direct impact system. It's used for notifications, reports, workflow triggers, and more. A compromised email system can lead to data breaches, regulatory fines, and disruptions to critical processes. Robust email protection ensures data integrity and cybersecurity.
ContinuousMP, a managed service by xLM, partners with Mailprotector® to provide comprehensive email security features.
These include:
Spam and Virus Protection: Advanced filtering algorithms block spam, phishing, and malicious emails.
Real-Time Threat Detection: Continuously scans and analyzes incoming emails for emerging threats.
Email Encryption: Protects sensitive information during transmission, complying with regulations like HIPAA and GDPR.
Bracket Email Encryption: Provides user-friendly end-to-end encryption for secure email communication.
Shield is a ContinuousMP feature that uses AI and adaptive learning to protect your inbox. It takes a zero-trust approach, stopping all threats and noise by default. Key functions include:
Advanced Threat Protection: Protects against phishing, malware, ransomware, and zero-day attacks.
Real-Time Monitoring: Instantly detects and mitigates threats to minimize risks.
URL and Attachment Scanning: Checks URLs for malicious destinations and scans attachments for hidden threats.
Email Privacy: Blocks spy trackers that can reveal personal information about you to the sender.
ContinuousMP provides uninterrupted email access, even during outages, through its Email Continuity feature. It offers:
24/7 Webmail Access: Users can send, receive, and access emails via a web interface, even if the primary email server is down.
Recent Email Access: Provides a copy of the last 30 days of emails for immediate access.
These features help organizations meet regulatory and organizational requirements for email recordkeeping:
Secure Archiving: Emails are stored securely and tamper-proof, preserving their original state.
Compliance Support: Helps meet GDPR, HIPAA, FINRA, and other regulatory requirements for email retention.
Efficient Retrieval: Advanced search capabilities allow for quick and easy retrieval of emails for audits or investigations.
ContinuousMP utilizes features like SafeSend and Recipient Confirmation:
SafeSend: Ensures sensitive information is handled appropriately, following compliance standards.
Recipient Confirmation: Requires users to verify recipients before sending sensitive emails, preventing accidental disclosures.
Burner Addresses are disposable email addresses that can be used to sign up for services or offers without revealing your primary email.
ContinuousMP allows you to:
Create and Manage Burners: Easily generate burner addresses and set expiration dates.
Control Message Flow: Choose to trust, silence, or block messages sent to burner addresses.
Protect Your Primary Email: Prevent unwanted marketing emails and protect your main inbox from spam.
ContinuousMP offers features that help users manage their inboxes more efficiently:
Email Bundling: Allows users to group less important emails and receive them at scheduled times.
AI-Generated Summaries: Provides concise summaries of bundled emails, allowing for quicker review.
Convenient Access: Bundled emails are accessible in a dedicated folder within the user's mailbox.
Continuous IT Operations and Management (cITOM)
Many manufacturing facilities, particularly those adhering to GxP regulations, face challenges with outdated alarm management systems. Common issues include:
Acknowledgement Without Action: Operators often acknowledge alarms without addressing the root cause, leading to recurring problems.
Alarm Overload: An excessive number of alarms, many of which are non-critical, can overwhelm operators and result in important alerts being overlooked.
Lack of Data Analysis: Historical alarm data is often disregarded, missing opportunities to identify recurring issues and improve processes.
Limited Knowledge Sharing: Systems often lack integrated knowledge bases, preventing operators from accessing historical solutions or contributing their own insights.
cITOM is an advanced incident management solution designed to address the shortcomings of traditional alarm management systems.
It enhances IT/OT resilience by centralizing alerts from various monitoring systems and ensuring timely notifications to the appropriate personnel. cITOM empowers teams to:
Respond to incidents swiftly and effectively.
Maintain operational continuity and minimize downtime.
Improve collaboration and communication during critical events.
cITOM employs several mechanisms to expedite incident response:
Centralized Alerting: Aggregates alerts from various monitoring tools for a unified view.
Multiple Notification Channels: Delivers alerts through email, SMS, mobile push, and voice calls, ensuring timely receipt.
On-Call Scheduling and Escalation: Routes alerts based on predefined schedules and escalates unacknowledged alerts automatically.
Alert Enrichment: Provides context to alerts by including charts, logs, runbooks, and other relevant data.
Yes, cITOM enables the automation of diagnostic and remediation tasks.
By integrating with platforms like AWS Systems Manager, cITOM can trigger pre-defined response playbooks based on specific alert conditions.
This reduces the reliance on on-call engineers, minimizing alert fatigue and MTTR (Mean Time to Resolution).
cITOM fosters team collaboration through:
Shared Incident Timeline: Provides a centralized log of all incident-related activities, ensuring transparency and accountability.
ChatOps Integration: Enables the creation of dedicated chat channels (e.g., Slack, Microsoft Teams) directly within cITOM for streamlined communication.
Web Conference Bridge: Facilitates immediate communication with key stakeholders via integrated web conferencing tools like Zoom or Twilio.
cITOM provides advanced reporting and analytics capabilities to gain operational insights:
Operational Efficiency Analytics: Tracks metrics like the number of alerts, acknowledgement times, and resolution times, allowing for trend analysis and identification of bottlenecks.
Monthly Overview Analytics: Delivers a comprehensive view of alert distribution and response trends, enabling month-over-month comparisons and insights.
Incident Investigation: Correlates incidents with code deployments from tools like Bitbucket and GitLab to pinpoint potential causes.
Yes, cITOM prioritizes data security and compliance with industry standards, making it suitable for GxP-regulated organizations.
Its robust features help these companies adhere to stringent data integrity regulations.
cITOM is offered as a managed service, ensuring continuous qualification of the software application, ongoing validation of the customer's instance, and thorough regression testing with each iteration.
Continuous Environmental Monitoring System (cEMS)
cEMS stands for Continuous Environmental Monitoring System, an AI-driven compliance tool for MedTech, biotech, and pharmaceutical sectors. It ensures 24/7 regulatory compliance by automating processes with real-time alerts, predictive analytics, and secure audit trails.
cEMS is essential due to strict regulatory requirements for accurate environmental records. Traditional methods are inefficient and error-prone, posing compliance risks. cEMS automates monitoring, integrating temperature tracking and AI analytics to prevent issues like sensor malfunctions in pharmaceutical facilities.
Key features include:
Advanced Data Logging: High-precision sensors monitor temperature, humidity, and more, with annual replacements eliminating calibration needs.
Real-Time Monitoring: Proactive alerts via various channels for deviations, with customizable workflows.
Predictive Analytics: Machine learning for trend forecasting and maintenance alerts.
AI-Driven Temperature Mapping: Enhanced mapping and validation with actionable insights.
Regulatory Compliance: Adheres to global standards with secure, encrypted data storage and audit trails.
Visual Dashboards: Real-time data visualization and customizable reports with API support for integration.
cEMS offers advanced AI-driven automation, replacing sensors annually without calibration, utilizing predictive analytics, and providing a modern user interface. It focuses solely on Life Sciences and ensures continuous monitoring with low total cost of ownership.
Companies gain unmatched compliance, accuracy, and efficiency, protecting product integrity and enhancing operations through predictive intelligence and 24/7 monitoring.
Continuous Robotic Process Automation (cRPA)
cRPA represents an AI-driven digital workforce comprised of intelligent agents that execute regulated tasks within enterprise systems such as SAP, Veeva, or ServiceNow. It facilitates natural language interactions, whether through chat or voice, and guarantees comprehensive traceability—including timestamps, screenshots, and digital signatures—to meet GxP audit compliance requirements.
cRPA ensures that all actions performed by the agents in backend systems are automatically recorded with audit-grade precision. This includes detailed logs, screenshots, timestamps, and electronic signatures. The system is inherently compliant with regulatory standards such as FDA 21 CFR Part 11 and EMA Annex 11.
Conversational interfaces available across Teams, web, and mobile, eliminating the need for tedious form filling.
Role-aware dashboards that provide user-specific insights.
Autonomous execution by digital agents with complete traceability.
Auto-documentation that automatically generates structured records.
Natural-language understanding for processing voice or text commands.
Built-in compliance tailored specifically for GxP environments.
cRPA is designed on a modular, cloud-native architecture that includes the following components:
CI/CD Pipelines: Ensuring version-controlled development with QA-approved deployments.
Backend APIs & Workflow Engine: Responsible for orchestrating and routing tasks.
Frontend Delivery: Web interfaces that are accessible across various devices.
Database Layer: Stores workflow logs, sessions, and audit trails.
Autonomous Agents: Execute tasks within target enterprise applications while capturing complete audit details
cRPA is capable of automating a diverse array of routine and regulated workflows across departments such as Quality, Operations, IT, and Compliance. This includes tasks like approvals, data entry, form population, change tracking, logbook management, reporting, and more. Whether initiated through chat, voice, or system events, cRPA agents manage tasks from start to finish, ensuring speed, accuracy, and full adherence to regulatory standards.