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xLM’s ContinuousDI

Goal is to provide a set of managed services to go from where you are to Continuous Data Integrity (cDI) Compliance.

cDI Program based on ALCOA+. All our programs include Enterprise wide Data Integrity (DI) Assessment Services that encompasses Clinical, Manufacturing and/or Laboratory areas within a life science company.

Includes the following DI Categories: GxP Data Integrity, Data Governance, Data Lifecycle, Original Records / True Copies, All Computer System Transactions, Audit Trails, Data Review, User Access/System Admin Roles, Data Retention and Archival, Backup & Disaster Recovery, File Structures, System Validation, System Interfaces, and Data Risk Assessments

cDI Benefits

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Compliance Speed to full cDI Compliance in weeks.
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Managed Services Leverage our packaged managed services that is continuously validated and with best practices baked in.
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Cost We can beat any of our competitors price.
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Validation You will be getting a continuously validated service and NOT just an IT Service.
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No hardware or software to buy We provide managed services and do all the heavy lifting.
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Performance All our managed services are best in class.
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Pro Services Our Pro Services to give you a full deck: Fractional vCISO, Fractional vCOO, Auditing, FDA CSA Consulting, Cyber Security & Data Integrity Assessments.
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Support 24/7, 365 Days support
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Experience Over 30 years experience providing GxP Services to Global Clients. 
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Trust

Our managed services adhere to our QMS which is based on ISO9001-2015, 21 CFR Part 11/ Annex 11.

Use TLS to protect information while in transit across the Internet. We have implemented TLS1.2 and Perfect Forward Secrecy (PFS) to further support data protection.

Benefits

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Technology Partners

cDI Platform Architecture

Powered by ATLASSIAN
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cDI Platform Key Features

Scrum Boards

Scrum boards help agile teams break large, complex projects into manageable pieces of work so focused teams, working in sprints, ship faster.

Roadmaps

Keep your teams and organization in sync with roadmaps.

Intuitive Analytics

Make data-driven decisions in record speed with Analytics. Use pre-built or customized dashboards to analyze your data across teams and projects.

The Data Lake offers fully modeled data across apps for faster analysis, directly inside the Platform or in your BI tool of choice.

Drag & Drop Automation

Focus on the important things.  Let automation do the rest.  Automation is simple, but powerful.

E-Sign any record

Execute electronic signatures on any issue. Each signature contains signee name, title, date/time, signature meaning and is locked cryptographically to the Issue.

PDF Signature Archives

Will capture a PDF point-in-time snapshot of 
the complete “Signed” issue. 

PDF includes standard fields, description, attachments, comments and all custom fields, plus eSign signatures , invites and verification.

Daily and On-demand Backups

Save time from manual exports and scripts with automated daily backups.

Trigger on-demand backups for all or specific projects or objects including attachments. Monitor and report backup activity for compliance.

Pre-built Dashboard Templates

Instantly build reports with Power BI dashboard templates and pre-configured data sources. Just download one of the templates and get your report in Power BI without a hassle.

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cDI Platform Additional Features

shield-biconSecure and Compliant Safeguard user accounts with built-in support for SAML single sign-on, and triage suspicious behavior with organization audit logs.
uptime-biconSuperior Uptime and Support Guaranteed 99.95% uptime SLA and a 30 minute support response, 24/7.
integration-biconIntegration
  • Full Office 365 Integration
  • Power BI Integration

cDI Managed Services

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c-itom

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#1

Powered by XQUAL

ContinuousALM lets you manage requirements, specifications, traceability, test cases (both Manual and automated) as well as deviations. You can: 

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Structure your releases down to components
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Define your business requirements
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Write your functional and technical specifications
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Manage your projects using Agile/V-model practices
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Design Your tests and test case procedures
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Orchestrate your test and test plans
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Plan and execute your test campaigns
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Archive and compare your test results
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Report on coverage, results, progress, quality
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Track your bugs

ContinuousALM Key Features

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Requirements Management

You can easily see the requirement coverage in terms of tests.  You can also view requirements related statistics.

Requirement Statistics

You can obtain various KPIs related requirements organized by priority, approval stats, risk stats...and more.

Requirement Traceability

You can view the traceability flow between requirements and tests.

Test KPIs

You can view various test metadata, statistics and KPIs

Test Case Execution Results

A dashboard displaying the results of test cases related to a test.

Test Campaign Results

A dashboard displaying the execution results related to a test campaign.

Test Campaign Execution Coverage by Requirements

A dashboard that displays the requirements coverage by Test Execution.

Bug (Deviation) Statistics

Global bug statistics by Status, Severity, Priority...and more..

ContinuousALM Additional Features

methodalogy-biconMethodologies Supported
  • Agile
  • V-Model
  • RUP
  • Kanban
connectors-biconConnectors
  • Support for more than 90 launchers
  • QTP/UFT, Selenium/WebDriver, JMeter, SoapUI, Robot Framework, Cucumber, Telerik, Ranorex, TestComplete, Postman, Tape
devops-biconDevOps Connectors to many Continuous Integration (CI) systems including Bamboo, Jenkins, Hudson, TeamCit
enterprice-biconEnterprise integration Real-time connectors to JIRA, VersionOne, Bugzilla, Mantis, Clearquest, VersionOne, Redmine, QC, YouTrack
dashboard-biconKPIs
  • One-Click progression assessment on requirements and specification completion
  • One-Click testability and quality assessment 
  • Radar-based at-a-glance status
system-biconSoftware Quality Built-in
  • Support for automated and manual test execution
  • Dedicated exploratory testing module based on Session-Based Test Management (supports FDA CSA)
lens-biconData Visualization
  • Dimension-based and time-based data analysis diagrams for any object
  • Export reports in xml, html, csv (Excel), docx(Word) and pdf formats
  • System, Requirements, Specification coverage/results
ContinuousALM Features calm-features

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#2

Powered by ATLASSIAN

A robust, sophisticated Document Management System ready to manage your regulated as well general documents. ContinuousDM includes Records Management, ability to customize workflows, detailed audit logs and granular security.

ContinuousDM Key Features

Build customized review processes

Use the Workflow Builder to create customized review and approval processes that meet your unique needs.

Restrict Access to Confidential Information

Share and restrict access to sensitive information.  Restrict access to confidential information by leveraging user groups.

Improve compliance with centralized audit logs

View centralized audit logs showing who has accessed, created, modified, attempted and deleted the secretes, all at the fingertips of the administrators.

Easily organize pages based on sensitivity & risk

Unstructured, poorly organized data is difficult to protect. Use built-in data classification levels to easily categorize pages based on their sensitivity and make informed decisions to mitigate the risk of data loss.

Reduce risk with level-based page permissions

Reduce the risk of data exposure in with classification-level-based page restrictions. Align page access to your data governance policies and centrally manage which users/groups have view or edit permissions.

#3

Powered by ATLASSIAN

ContinuousSM is a robust service management solution, meticulously designed to empower teams across various domains. It seamlessly integrates service request management, incident handling, problem resolution, change management, knowledge sharing, asset tracking, and configuration management.  Leveraging these robust features, xLM’s team can manage all your service requests in compliance with GxP as well as ITIL.

ContinuousSM Key Features

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Request Management We can manage requests of any type with assigned workflows while the requestor can monitor progress from the portal.
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Change Management Our IT operations teams are empowered with richer contextual information around changes so they can make better decisions and minimize risk.
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Integration We can integrate with your favorite software tools. Build custom add-ons with our REST API and open platform to supercharge our service desk.
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Incident Management Our teams can work together with all stakeholders to rapidly respond, resolve and continuously learn from incidents.
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Asset Management Store assets to manage inventory efficiently, track ownership and lifecycles, and reduce costs.
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Mobile With the Service Management mobile app, submit, approve, and resolve issues quickly, from wherever you are.
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Problem Management We can group incidents to problems, fast-track root cause analysis, and record work arounds to minimize the impact of incidents. 
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Configuration Management We can gain visibility into the infrastructure that support critical applications and services. Understand service dependencies so risk can be minimized.
ContinuousSM Features calm-features

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ContinuousSM Additional Features

Software License Monitoring

We can get a high-level view into your cloud resources by utilized, idle, or unallocated. Integration with cloud providers like Microsoft 365. Ability to track manually added third-party software of any type (BOX, OEM, ESD).

Domains & SSL Certificates Expiry Monitoring

We can manage and track all of your organization's Internet domain and SSL certificates to ensure they don't expire and prevent domain hijacking.

#4

Powered by ATLASSIAN

ContinuousRM offers a comprehensive suite of features to help you identify, assess, and mitigate potential risks.  It provides a centralized repository for tracking risks and measures across multiple projects, with real-time insights into risk issues.  The apps facilitate the planning, development, and tracking of risk mitigation strategies, and enable the generation of powerful reports for informed decision-making. 

ContinuousRM Key Features

Manage Risks in Customizable Risk Table View

Identify, evaluate and mitigate risks in a familiar spreadsheet view.  Quick Overview, Easy Sorting and Automated Risk Traceability.  Link Risks to existing issues.

Manage Risks in any project

Enable Risk Management features in any of your existing projects.  Create and manage risks easily in the issue views.  Simply add Severity and Probability values to automatically calculate the Risk score.

Custom Risk Models(Matrices or RPN Scores)

Manage your risks with the method you want – Risk Matrices or RPN. Define up to 10 Risk Characteristics (Severity, Probability, Detectability, etc) & up to 10 Risk Iterations (Initial, Current, Target, etc)

Identify, mitigate, verify & trace risks

A fully customizable Multi-Sheet Risk Table to manage risks with any method. Complete traceability of risks through links to mitigation actions and test cases. Quick filtering and sorting of risks for better overview.

Report your Risks

Add the Risk Matrix, Risk Table and Risk History Reports on your pages with live links to Risks.

ContinuousRM Additional Features

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Templates Comes with customizable built-In templates for Hazard Analysis (15014971), FMEA (IEC60812), Project risks and a DIY risk template. 
shield-biconCompliance Audits Automated traceability, Risk Reports, Dashboard gadgets and full risk history for your compliance audits. 
shield-biconSystematic Analysis

Calculation of numeric fields through mathematical expressions, aiding in systematic analysis.

#5

Powered by ATLASSIAN

ContinuousITOM is a modern incident management platform designed to ensure that critical incidents are promptly addressed by the xLM’s staff. Here’s a concise overview:

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ContinuousITOM Key Features

  • Multiple Alerting Channels
  • Alert Enrichment
  • Custom Alert Actions
  • Alert Customization and Classification
  • Alert Lifecycle Tracking
  • Alert & Notification Policies
  • Heartbeats
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Actionable & Reliable Alerting Ensures we will never miss a critical alert. With deep Integrations into monitoring, ticketing, and chat tools, Operations Management groups alerts, filters out the noise, and notifies us using multiple channels. Thus providing the necessary information for our team to immediately begin resolution.
  • On Call Schedule Management 
  • Routing Rules and Escalations 
  • On-Call Overrides 
  • On Call Reminder Notifications 
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On-call Management & Escalations Makes on-call management easy. We can modify schedules and define escalation rules within one interface. Our team will always know who is on-call and accountable during incidents. We will always have the confidence that critical alerts will be acknowledged.
  • Operational Efficiency Analytics
  • Monthly Overview Analytics
  • Downloadable Schedulable Reports
  • User & Team Productivity Analytics
  • On-Call Analytics
  • Conference Attendance & Efficiency Analytics 
  • Post-Incident Analysis Reporting
  • Service & Infrastructure Health Reporting
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Advanced Reporting & Analytics Helps us gain Insight Into areas of success and opportunities for improvement. Tracks everything related to alerts and incidents. Powerful reporting and analytics helps in revealing the source of most alerts, our team’s performance in acknowledging and resolving, and how on-call workloads are distributed.
  • Planning and Scenarios 
  • Stakeholder Communications 
  • Alert Clustering 
  • Post-Incident Analysis 
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Service Aware Incidents Management We can understand how issues impact your business services and will help proactively communicate outages to all stakeholders. We can plan ahead of service disruptions and have the system send messages, create status pages, and establish conference bridges immediately when Incidents occur. Distractions are minimized, and teams stay focused on a resolution.
  • ChatOps
  • Web Conference Bridge
  • Stakeholder Communications 
  • Incident Command Center (ICC)
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Communication and Collaboration Effective communication and collaboration are the keys to fast response times. Provides deep integrations into our chat tools so we can take action and collaborate easily. We can create virtual war rooms to orchestrate a response between multiple teams and keep stakeholders up to date using mass notification capabilities.

#6

Powered by SOPHOS

ContinuousMTR is a fully-managed service that combines machine learning with human analysis to deliver proactive security protection. It offers 24/7 threat hunting, detection, and response by an expert team. Unlike other managed detection and response (MDR) services that merely notify you of attacks, ContinuousMTR takes targeted actions on your behalf to neutralize even the most sophisticated threats. The service arms your organization with a highly-trained team of threat hunters and response experts who proactively hunt for and validate potential threats, determine their scope and severity, and apply appropriate business context. They initiate actions to remotely disrupt, contain, and neutralize threats, providing actionable advice for addressing recurring incidents. ContinuousMTR is built on top of Intercept X, a world-class endpoint protection solution, and fuses machine learning technology with expert analysis for improved threat detection and rapid response. It’s like having a dedicated team of security experts working tirelessly to keep your organization safe from cyber threats!

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Alert Management ContinuousITOM receives alerts from monitoring your systems and custom applications. It categorizes each alert based on importance and timing, ensuring that no critical incident goes unnoticed.
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On-Call Schedules The platform maintains on-call schedules, notifying the appropriate xLM personnel through multiple communication channels (such as voice calls, email, SMS, and mobile push messages) when incidents occur.
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Escalation If an alert remains unacknowledged, ContinuousITOM automatically escalates it, ensuring timely attention to the incident.

ContinuousMTR Key Features

Endpoints

  • Central Intercept X Advanced with XDR and MTR Advanced for - PCs and Servers
  • 24/7 Threat Hunting
  • Adversarial Detections
  • Security Health Check
  • Data Retention
  • Activity Reporting
  • Dedicated Incident Lead
  • Enhanced Telemetry
  • Proactive Posture Management
Read More... Read Less...

Central Mobile Advanced

  • Mobile Content Management (MCM), Intercept X for Mobile
  • Secure Workspace
  • Secure Email container apps
  • Unified Endpoint Management (UEM) for BYOD and business-owned
  • Mobile Device Management (MDM)
  • Mobile Application Management (MAM)
  • Mobile Email Management (MEM)
  • Device, Network, and App Security Centralized deployment, configuration, and reporting

Central Device Encryption

Management of Full Disk Encryption.
Supports BitLocker on Windows and File Vault on macOS

Firewalls

  • Xstream Protection with WAF and Email
  • Network Protection
  • Web Protection
  • Email Protection
  • Webserver Protection
  • Central Orchestration
  • Enhanced Support
  • Zero-Day Protection

Central Cloud Optix

  • Agentless multi-cloud security and compliance
  • Automated benchmark and compliance reporting, including custom policies
  • Smart alerts
  • Resource Inventory
  • Network topology visualization
  • AI-powered anomaly detection
  • Proactive Infrastructure-as-Code template file scanning
  • Third-party tool integrations for remediation

#7

Powered by ATERA

ContinuousRMM is a robust software solution to remotely monitor and manage your IT assets. It provides real-time insights, proactive issue detection, and streamlined IT operations. Key features include real-time monitoring, remote control, automated maintenance tasks, patch management,
and reporting. ContinuousRMM ensures system health and performance across unlimited devices,
and sites.

ContinuousRMM Key Features

Real-time monitoring and alerts

We can monitor system activity in real-time, and scale up to manage as many devices, or sites as you need. With automated alerts and thresholds for different device types, we get full visibility into device or group behaviors that keep you ahead of the game and two steps ahead of any looming incidents. We can set specific alert thresholds for different device types customized according

IT automation

We can use threshold profiles, which can automatically take action based on a trigger.  Our robust script library has hundreds of scripts, all of which can be run directly using PowerShell, CMD files, and more.

  • Create System Restore Point
  • Delete Temp Files
  • Delete Internet History

Patch management

We can manage all OS patches for Windows and Mac, automate software installation, patching and updates for a wide range of software.

  • Run Windows Update: All / Critical / Important / Security.
  • Run Windows Update: Service Pack
  • Install Microsoft Office Updates
  • Install Driver Updates (Hardware)
  • Install Java updates

Integrated remote access

We can integrate with Splashtop, AnyDesk, TeamViewer and ConnectWise.

  • Access desktops, servers, applications, files and data with ease
  • Share screens, send files, and establish remote control
  • Use AnyDesk to record a shared screen
  • Securely log in from anywhere, globally
  • Open Remote Desktop from a device, ticket or alert for quick time to value
  • Chat with users in real-time to resolve issues

ContinuousRMM Additional Features

battery-biconAsset and inventory scanning
  • Hardware distribution
  • Software inventory
  • Operating System distribution
  • MS Office distribution
Read More... Read Less...
graph-biconReporting and analytics

Our wide range of reports and analytics allow us to set and keep track of data-driven goals, including:

  • System health at-a-glance
  • Agent health
  • System inventory audit
  • Microsoft Licensing
time-biconComplete Activity Log Every single action or command that user issued is automatically logged into the main database. We will have total traceability so we can really keep a 360° view of what's going on inside your IT systems.
monitor-biconSNMP Monitoring With automatic OID monitoring on Linux-based devices (routers, firewalls, PCs, etc.) we now have the capacity to monitor all of your printers, routers, and other SNMP devices.
ContinuousRMM Features calm-features

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#8

Powered by MAILPROTECTOR

ContinuousMP Key Features

Overview Statistics

Statistics of the Delivered Mails, Spam Mails, Policy Mails, Attacks, Viruses and Total Mails
for Inbound and Outbound within a domain
for a specific period.

Full support for Microsoft 365 & Google G-Suite Workspace

ContinuousMP provides full support for M365 and Google G-Suite.

Organization Message Statistics Dashboard

Provides our team with detailed message statistics across your entire organization. 

Message Filtering

Sophisticated message filtering engine to control Spam, etc..

Options

Options include Cloud Filter (Email Security), Bracket (Encrypted Email), Dropsuite (Backup
and Archiving), SecureStore (Archiving), XtraMail (Email Continuity)

Message Analytics

Provides rich message analytics that is extremely useful for our support teams.

Shield

Shield is more than just another email filter. Way more…  Shield is designed to silence the noise we all feel with email. It’s like having noise-cancelling headphones for your inbox, putting the user back in control.

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ContinuousMP Additional Features

bracketmail-biconBracket Email Encryption
  • Easy to use email encryption with no plugins or apps. Bracket has turned using email encryption from dread to delight. Just wrap brackets around the [subject] in any email client on any device, and Bracket handles the rest.
  • Bracket now includes Share, our secure file transfer service, for every user at no additional cost.
cloud-biconCloud Filter Email Filtering
  • Total email security that filters all the junk people don't want.
  • CloudFilter delivers full-stack protection from annoying spam and crippling email-based ransomware and Phishing attacks in a way that's effective, efficient, and easy to use.
safesend-biconSafesend Email Compliance
  • Prevents spam proliferation and keeps damaging or sensitive data from being leaked via email.
  • SafeSend expands beyond CloudFilter’s outbound filtering by giving greater control over outbound email traffic with custom content rules and more.
xtramail-biconXtraMail Email Continuity
  • It’s like s spare tire for an email server.
  • With XtraMail, our customers have 24/7 access to an affordable, always on, copy of their last 30 days of email.
  • When their email servers go down, users can login to XtraMail’s webmail and keep emailing from the same address.
bf-icon-four 1Shield
  • Zero-trust security at the core
  • A security HUD (heads up display) in every email
  • X-ray view clearly explains key sender integrity data points
  • Blocks spam, viruses, and phishing
bf-icon-fivePrivacy
  • Hide who you are/what you say
  • Blocks embedded spy trackers
  • Create burner addresses to keep your main email address private
  • Lock/Unlock any sensitive email from being read in your inbox

Professional Services

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FAQs

1. What Al features does cDI Stack have?
ContinuousRMM's Al features include:
 
  • Auto ticket summaries
  • Auto-generated response
  • Ticket solution suggestions
  • Automated script generator
 
ContinuousSM
 
  • Automated issue suggestions: Uses machine learning to suggest issues based on user activity and patterns.
  • Predictive prioritization: Helps prioritize bugs and issues based on their potential impact and severity, using Al.
  • Smart search: Enhances search capabilities with natural language processing to understand the context of queries.
  • Similar issues: Recommends similar issues to avoid duplicates and streamline workflow.
  • Next-gen project templates: Suggests project templates based on the team's needs and past project setups.
 
ContinuousDM
 
  • Smart links: Automatically transforms links pasted Into pages Into rich content previews.
  • Content recommendations: Suggests relevant articles and documents to users based on their work and interests.
  • Meeting notes assistant: Summarizes key points and action items from meeting notes using natural language processing.
  • Page Insights: Provides suggestions for improving content quality and engagement based on analytics.
 
ContinuousITOM
 
  • Incident prediction: Identifies patterns that could indicate potential incidents before they occur.
  • Smart alert routing: Automatically routes alerts to the most appropriate responder based on past incident data.
  • Noise reduction: Filters out redundant alerts using Machine Learning to reduce noise and focus on critical issues.
 
ContinuousMTR
 
Offers a range of features that leverage artificial intelligence (AI) and machine learning (ML) technologies to enhance threat detection, response, and prevention capabilities. While specific Al features may evolve over time, the core aspects of MTR typically include:
 
  1. Al-Powered Detection: MTR uses Al algorithms to analyze behavior patterns and detect anomalies that may indicate a threat. This includes identifying suspicious activities and malware that traditional signature-based detection methods might miss.
  2. Machine Learning Models: It incorporates advanced machine learning models that are trained on vast datasets of security threats. These models improve over time, adapting to new threats and reducing false positives.
  3. Threat Hunting: Leveraging Al, MTR conducts proactive threat hunting across the network. This involves searching for signs of compromised systems and indicators of attack (loAs) that suggest a breach or an ongoing attack.
  4. Automated Response: MTR utilizes Al to automate certain response actions to threats, enabling faster mitigation and reducing the window of opportunity for attackers. This includes isolating affected devices, terminating malicious processes, and applying security patches.
  5. Behavioral Analytics: By analyzing the behavior of users, applications, and network traffic, MTR identifies patterns that deviate from the norm, which could indicate a cyber threat or compromise.
  6. Adaptive Threat Response: Al is used to tailor the response to the specific characteristics each detected threat, ensuring that the response is proportional and effective.
  7. Security Analytics and Reporting: MTR provides detailed analytics and reports on security events, leveraging Al to highlight trends, identify vulnerabilities, and recommend actions to improve security posture.
  8. Integration: MTR integrates with other products using Al to provide a coordinated and comprehensive security strategy across endpoints, networks, and cloud services.
 
ContinuousValidation
 
  • ContinuousValidation incorporates Computer Vision, Al LLMs to identify Ul screen objects. This new technology is far superior than traditional test automation technologies. This enables xLM to manage software changes very efficiently and reliably.
  • xLM is investing in Al LAM (Large Action Model) technology to mimick how a human interacts with software. This will enable xLM to fully integrate next gen test automation technology into the platform. This will help us increase coverage, perform more advanced testing, manage changes efficiently while increasing compliance.
2. What is roadmap for a full stack implementation of cDl?

Step 1

xLM will perform a detailed Data Integrity Assessment to understand your landscape. This assessment includes:
 
  • GxP Data Integrity
  • Data Governance
  • Data Lifecycle
  • Original Records / True Copies
  • Computer System Transactions
  • Audit Trails
  • Data Review
  • User Access/System Admin Roles
  • Data Retention & Archival
  • Backup & Disaster Recovery
  • File Structures
  • System Validation
  • System Interfaces
  • Data Risk Assessments
  • Cyber Security Posture

Step 2

  • Formulate recommendations based on Gap Analysis.
  • Finalize an implementation plan based on your priorities, objectives, resources, current systems/contracts, budgets and DI gaps.

Step 3 (Optional)

  • Appoint a fractional vCISO from our partner Trava Security and a fractional vCQO from xLM.
  • This will ensure leadership within your IT in areas of Cyber Security and IT Quality.

Step 4

  • Develop an IT Quality Manual.
  • Identify all new policies and procedures that need to be developed.
  • Identify existing policies and procedures that need to updated.
  • These policies and procedures need to address, but not limited to the following areas: IT Security, Acceptable Use, Identity and Access Mgmt, Incident and Problem Mgmt, Risk Managment, Information Classification, IT Asset Protection, Business Partner Risk Mgmt, Change and Configuration Mgmt, Business Continuity and Disaster Recovery, IT Infrastructure Qualification, IT Supplier Auditing, etc..
  • Develop/Update and obtain approvals on the Quality Manual and Policies / Procedures.

Step 5

  • Identify cDI Managed Services required to fill in the gaps and comply with the new IT Quality Manual.
  • Finalize MSA for Subscriptions.

Step 6

cDI Managed Service Onboarding
  • xLM's team will follow their onboarding process for each of the Managed Services.
  • The end result is deployment of a validated instance for each of the managed cDI services.
  • Customer Training.
  • Data Migration and corresponding validation.
  • Hypercare Support.
  • Ongoing managed services.

Step 7

  • Conduct monthly status calls to provide various metrics related to the performance of managed services.
  • Continuous Improvement.
  • Ongoing Change and Configuration Mgmt.
3. Can we pick cDI and Pro Services a la carte?
You can select any one or more services to meet your current situation, objectives and budget. 
4. Does your cDI comply with FDA's CSA?

xLM's cDI managed services complies with FDA's CSA.

fda-csd-flow-diagram

 

5. Does your cDl comply with 21 CFR Part 11 / Annex 11?
  • Every managed service is qualified in a xLM Test Environment.
  • Every customer instance is deployed and validated.
  • Customer's instance is maintained in a validated state with 100% regression.
  • Every service is evaluated for 21 CFR / Annex 11 compliance and such features are included in Qualification / Validation testing.
6. What is our QA's role in approving our instance's validation artifacts?
  • Every single validation artifact is released for customer's QA approval.
  • The entire validation library is organized and made available in a dedicated portal.
7. What are the cDl services available for use to the customer?
  • The following cDI instances are configured and managed by xLM. These Services are available to the customer to use on a daily basis:
  • ContinuousDM
  • Continuous ALM
  • ContinuousRM
  • ContinuousSM (for opening tickets and approving them)
8. How can we manage our internal validation activities?
  • We recommend that you use ContinuousALM for managing your Validation Assets (Systems).
  • You can manage projects, products and validation tasks here.
  • ALM fully supports Requirements, Specification, Tests and Test Case as well as Test Execution Mgmt.
  • You can manage bi-directional traceability.
  • Export any report into word so that you can use your own templates before approving. For example an URS, FDS, Test Protocol, etc.
9. Can you manage and monitor our IT Infrastructure?
  • Yes. We can completely manage your IT Infrastructure.
  • This includes both On-Prem and Cloud Assets.
  • We can manage your GxP IT Assets as well as Non-GxP Assets including Desktop PCs and Laptops.
  • We provide 24/7 365 support.
  • Our Change and Configuration Mgmt coupled with state of the art Al based pro active toolset ensures IT compliance.
10. What role does our Internal IT play?
  • We will be reporting to your Internal IT and QA.
  • It does depend on the Service Bundle your choose.
  • Generally speaking, all our services will be provide by working hand in hand with your IT leadership.
  • xLM will be part of your IT Department and will coordinate as required.
  • Since we provide managed services, the burden on your IT is very minimal since we bring the best toolset and industry best practices with a goverance framework that exceeds FDA or any other health authority expectations.
11. Can we perform an audit of xLM?
  • Yes. Our Engagement Manager can coordinate an audit.
  • We will also provide our Quality Manual and a comprehensive xLM QMS documentation once the contract is signed.

#9

Continuous Validation

What Is Continuous Validation?

Manual cloud app validation is costly and time-consuming. A continuous validation framework accelerates timelines, maximizes efficiency, and ensures data integrity while giving you the peace
of mind of staying GxP compliant. 

Key Benefits of Continuous Validation

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COMPRESSION of
validation timelines
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REDUCTION in cloud app
validation spend
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REGRESSION with every
new release

The 4-Step Validation Process

step-pre-validation
Pre-Validation
  • Validation plan
  • User requirements specification
    (URS)/functional requirements
    specification (FRS)
  • Configuration specification for
    that particular software
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Script Development
  • Prepare script
  • Run Dev pipeline
  • Fix codebase if required
  • Re-run Dev pipeline
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Testing
  • Run release pipeline
  • Generate reports
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Reports
  • Reports review checklist
  • Prepare package
  • Shipment
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High Test Coverage
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High Data Integrity Assurance
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Full Coverage for Patches & Upgrades
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Full Coverage for IaaS, PaaS, and SaaS
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21 CFR Part 11/ Annex 11 Compliant
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Robust Testing
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Integrated Risk
and Traceability
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Historical Test Data Analysis
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Flexible Framework

Every Continuous Managed Service is part of our Continuous Validation Program

  • In every service we offer, the software product is continuously qualified.
  • Also the customer's instance is continuously validated.
  • In each run, 100% regression is performed.