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- #038: Are you a Biotech or a Medtech? Here are the 8 Out of the Box Apps that can run your company; Delivered Validated!
#038: Are you a Biotech or a Medtech? Here are the 8 Out of the Box Apps that can run your company; Delivered Validated!
Continuous Data Integrity (cDI) managed services are specifically designed to be Data Integrity compliant and delivered validated.
Nagesh Nama
December 04, 2024 • Estimated Reading Time: 15 minutes
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Table of Contents
1.0. cDI Suite - 8 Apps that can run your company
You can be up and running in a day! Built for GxP, Data Integrity and 21 cFR Part 11 compliant and delivered validated!
1.1. Key Differentiators
Comprehensive Suite of Services: cDI provides an extensive range of managed services, including ContinuousDM, ContinuousALM, ContinuousRM, ContinuousSM, ContinuousITOM, ContinuousMTR, ContinuousRMM, and ContinuousMP. Each service is customized to be data integrity compliant with all best practices baked in.
FDA CSA Compliance: These services adhere to the FDA's Computer Software Assurance (CSA) guidelines, ensuring that systems are validated and meet all regulatory requirements.
21 CFR Part 11 / Annex 11 Compliance: cDI services ensure that each customer instance is deployed and maintained in a validated state with 100% regression testing.
Rapid Deployment: cDI services facilitate quick setup of an organization’s entire IT stack, integrating best practices and continuous validation from the outset.
Data Integrity Principles: Grounded in ALCOA+ principles, cDI services ensure that data is attributable, legible, contemporaneous, original, accurate, and complete, with an additional emphasis on data that is enduring and readily available.
2.0. App #1: Continuous Application Lifecycle Management (cALM)
ContinuousALM aims to transform software development by incorporating compliance with Part 11 standards and optimizing workflows, especially in GxP-regulated environments. The platform introduces advanced System Under Test (SUT) Management for precise tracking and organization, ensuring clarity and accuracy throughout the testing process.
Users benefit from the adaptable Coverage by Requirements, Specifications, and Tests feature, allowing manual adjustment of coverage levels and prioritization of specifications based on project objectives, thus enhancing testing precision and efficiency.
Moreover, the platform facilitates Requirements and Specifications Management with seamless integration capabilities with external systems such as Jira and VersionOne. Its risk-based testing functionality empowers teams to assign risk levels to requirements, automate test selection, and streamline reporting by considering failure probability and impact. Noteworthy Test Management features offer a well-structured framework to boost productivity and expand capabilities for API testing, stress tests, and more.
By incorporating Campaign Management and Defect Management, ContinuousALM ensures complete transparency and traceability across test campaigns and bug tracking.
Real-time updates on status, intuitive visual metrics, and centralized repositories contribute to efficient defect resolution. Furthermore, the platform aids in compliance with regulatory standards through Audit Logs, Traceability Matrices, and Versioning tools, assisting users in maintaining data integrity throughout the software lifecycle.
Lastly, the platform's Automation Integration and reporting functions establish ContinuousALM as a comprehensive solution for enhancing software development efficiency. It offers seamless integrations with popular tools like Jenkins, Selenium, and JMeter to support continuous testing and validation.
With a robust reporting engine, the platform delivers automated insights, empowering teams to achieve software excellence at every phase of the project.
3.0. App #2: Continuous Service Management (cSM)
ContinuousSM revolutionizes service management by offering a robust and agile platform that seamlessly integrates compliance and operational efficiency. In the face of escalating complexity within processes, especially in regulated settings, the demand for a reliable service management solution becomes imperative.
Every process whether GxP or Non-GxP can be accompanied by intelligent forms that move via intelligent workflows while providing intelligent metrics executing within the guardrails of intelligent compliance.
Conventional approaches often rely on outdated methods, resulting in inefficiencies and compliance vulnerabilities. ContinuousSM tackles these issues by delivering intelligent, automated workflows crafted to boost performance and guarantee adherence to GxP regulations.
4.0. App #3: Continuous Document Management (ContinuousDM)
Continuous Document Management (ContinuousDM) revolutionizes the way organizations handle, collaborate on, and safeguard their documents. It is crafted to streamline workflows, ensure adherence to regulations, and boost productivity.
ContinuousDM boasts powerful features like Audit Trails and Version Control that monitor document modifications and approvals to uphold data integrity. Real-time collaboration empowers teams to seamlessly collaborate on shared documents, while search capabilities deliver swift and easy access to vital content.
With advanced customization options such as custom workflows, e-signature integration, and robust encryption, ContinuousDM is built to meet GxP Compliance out of the box without compromising on user experience. The platform seamlessly integrates with popular tools like Microsoft Teams, Slack, and Google Drive, enabling teams to collaborate efficiently without the need to switch platforms.
The system is equipped with macros, whiteboards, and AI-powered insights for cutting-edge document analysis, enhancing decision-making and facilitating intelligent workflows. Users can harness these tools to automate tasks, generate dynamic content, and streamline document processes.
ContinuousDM's data classification and permissions ensure heightened security by regulating access based on document sensitivity, while export functionalities in various formats offer versatility for sharing and archiving.
5.0. App #4: Continuous Risk Management (ContinuousRM)
ContinuousRM revolutionizes risk management for organizations by introducing a proactive framework for continuous risk identification, assessment, and mitigation. In today’s intricate regulatory environment, especially in the life sciences sector, effective risk management is paramount. Conventional risk assessment methods often fall short, devolving into mere checklists rather than active processes. ContinuousRM combats this issue by providing robust tools and features that empower teams to effectively handle risks.
Noteworthy components of ContinuousRM encompass customizable risk tables, dynamic risk models, and automated reporting. The Risk Matrix enables organizations to visualize and evaluate risks using customizable parameters, thereby facilitating well-informed decision-making. By automating risk identification, mitigation, verification, and tracking, ContinuousRM ensures organizations adhere to industry standards like ISO 14971 and Good Manufacturing Practices (GMP).
The significance of ContinuousRM in the life sciences domain cannot be overstated. It guarantees regulatory compliance, simplifies audits, upholds product quality, and bolsters business continuity by detecting potential disruptions early on. With an intuitive interface and comprehensive tools, ContinuousRM enables teams to seamlessly integrate risk management into their project cycles, transforming risk into an opportunity for enhancement and advancement.
6.0 App #5: Continuous IT Operations Management (ContinuousITOM)
ContinuousITOM is a robust incident management platform that aims to streamline IT operations by promptly addressing critical incidents. It boasts key features such as actionable alerting through various channels, customizable alert enrichment, and alert lifecycle tracking. These functionalities guarantee that teams never overlook crucial alerts and can efficiently prioritize tasks based on severity and impact.
Moreover, the platform simplifies on-call management and escalations by allowing easy adjustments to schedules and escalation protocols through a unified interface.
ContinuousITOM also offers advanced reporting and analytics capabilities, providing valuable insights into team performance, alert origins, and incident response times. This data empowers organizations to pinpoint areas for enhancement and optimize their incident management workflows.
Additionally, ContinuousITOM supports service-oriented incident management, aiding teams in comprehending the effects of incidents on business services. It facilitates proactive communication with stakeholders during downtime.
The platform also includes communication and collaboration features like ChatOps integration and an Incident Command Center (ICC), enabling teams to efficiently coordinate responses and keep stakeholders informed throughout the incident resolution process.
7.0 App #6: Continuous Mail Protector (ContinuousMP)
ContinuousMP is a managed service designed to deliver advanced email security and compliance solutions, specifically crafted for organizations operating in GxP-regulated industries. Given the crucial role of email in communication and collaboration within the life sciences sector, ContinuousMP guarantees that your email system adheres to data integrity and cybersecurity standards.
This service provides robust protection through key features like Real-Time Threat Detection, Spam and Virus Protection, and Email Encryption, effectively shielding against spam, phishing attacks, malware, and unauthorized data breaches. Through tools such as Bracket Email Encryption and SafeSend Compliance, it ensures the security of sensitive data during transmission and aids organizations in meeting compliance standards such as HIPAA and GDPR.
Seamless integration with Microsoft 365 and Google Workspace simplifies setup and management for users. ContinuousMP also offers Email Continuity during outages, ensuring uninterrupted access to emails and seamless communication. Moreover, features like Archiving and Compliance ensure secure storage of email records to meet regulatory requirements, while Message Analytics enables detailed monitoring of email security incidents.
The platform's AI-powered Shield provides state-of-the-art protection against sophisticated email threats by continuously monitoring and filtering emails in real-time, quarantining suspicious ones for further review. Spam Filtering, Virus Protection, and advanced email filtering mechanisms work together to block harmful content before it reaches the inbox.
By incorporating a burner email address feature, ContinuousMP enhances user privacy by generating temporary email addresses for events or registrations. Additionally, the Shield's spy tracker blocker thwarts senders from tracking email opens and activities, preserving privacy and mitigating targeted threats. ContinuousMP further secures sensitive emails with multi-factor authentication, ensuring their safety even in the event of an account compromise.
8.0 App #7: Continuous Managed Threat Response (ContinuousMTR)
ContinuousMTR Cybersecurity-as-a-Service, developed by xLM in collaboration with Sophos, provides extensive protection for IT assets in the manufacturing sector. With the rise of Industry 4.0 and smart factories, manufacturers face increasing risks from cyber threats such as ransomware, data breaches, production interference, and intellectual property theft. ContinuousMTR plays a crucial role in minimizing business risk exposure and enhancing data integrity compliance, particularly for GxP-regulated companies.
This service offers a range of key features, including 24/7/365 Managed Detection and Response (MDR), Zero Trust Network Access (ZTNA), Endpoint protection with Intercept X, and Extended Detection and Response (XDR) for comprehensive cybersecurity monitoring. It not only safeguards manufacturing IT assets but also industrial control systems, networks, cloud environments, and email accounts.
Utilizing AI-driven tools and multi-layered security approaches, ContinuousMTR effectively tackles insider threats, supply chain vulnerabilities, and outdated legacy systems. It aligns with the FDA's data integrity requirements and meets industry standards like HIPAA, GDPR, and PCI DSS, making it particularly suitable for life sciences and other regulated industries.
Core Capabilities:
MDR: Round-the-clock monitoring by security specialists
ZTNA: Ensures secure access with continuous validation of user identities and device health
XDR: Provides a unified platform for identifying, investigating, and responding to sophisticated threats
Supply Chain Protection: Mitigates risks from third parties through advanced threat detection
Legacy System Security: Utilizes Firewall and SD-RED technologies to safeguard older, vulnerable systems
Cloud Security: Protects multi-cloud environments with Cloud Optix and Intercept X for Servers
Compliance: Adheres to GxP, HIPAA, GDPR, PCI DSS, and other global regulatory requirements
Cyber Insurance Readiness: Establishes essential cyber controls to fulfill insurance prerequisites
9.0. App #8: Continuous Remote Monitoring and Management (ContinuousRMM)
ContinuousRMM revolutionizes the way organizations oversee, control, and safeguard their IT assets with a robust Remote Monitoring and Management (RMM) solution. Engineered to guarantee compliance, security, and operational effectiveness, ContinuousRMM empowers real-time monitoring of vital infrastructure and streamlines operations across GxP-regulated and non-regulated settings.
This platform boasts advanced functionalities like Real-Time Monitoring, delivering immediate alerts for system performance issues, and Patch Management, which automatically updates systems to fortify security. ContinuousRMM also seamlessly incorporates AI-driven automation, diminishing manual tasks by optimizing ticket management and proactively addressing concerns.
This system supports Network Discovery, Automated Reporting, and AI-fueled analytics, empowering IT teams to function more efficiently and tackle issues before they escalate. Continuous Validation guarantees asset compliance, mitigating risks and sustaining productivity. With its strong security measures, automation capabilities, and seamless integrations, ContinuousRMM empowers organizations to manage their IT infrastructure confidently.
10.0. ContinuousDI - Platform
11.0. xLM cDI Partners
12.0. Delivered Validated!
Such an AI driven system shall be managed under a Continuous Governance framework that ensures the outputs are predictable with no exceptions. Such a Governance Framework incorporates Continuous Validation.
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