VERTHOS QMS

VERTHOS QMS

VERTHOS QMS offers you the most customizable compliance and quality product with a fully integrated CAPA module. All processes can be easily customized by any system user and each process can be automatically validated by an authorized user. It includes the best analytics and reporting, providing flexibility to analyse your data and delivers complete visibility of your compliance system to reduce business risk. The fully mobile Native App supports working off line without standard internet connectivity and can be seamlessly synchronized. Using restful API’s and customer integration BOTS, VERTHOS QMS delivers the industry’s easiest integration with existing systems.

 

Five main reasons to consider VERTHOS QMS

  • MOST user Customizable with Validation
  • BEST Analytics and Reporting
  • FULLY mobile
  • EASIEST integration
  • Price Performance LEADER

 

MOST user Customizable with Validation

VERTHOS QMS includes all major QMS features like complaints, document control, change control, training management, CAPA management, deviation management, non-conformance, out-of-specification, audit management, risk management and supplier management.

MOST user Customizable QMS with ValidationVERTHOS QMS provides an unrivalled ability for the user to customize the entire QMS. It is the 1st QMS to provide automatic and instant design validation in accordance with 21 CFR Part 11 and Annex 11. Key features include:

  • Inter-organizational Process Design. Use the customization toolkit to design compliance, risk and quality process controls that span across departments, sub-divisions, external contractor, suppliers and customers. Get the benefits of collaboration–even across competing suppliers.
  • Collaborative Team Working Design. Create and maintain multi-step collaborative team work-flows with tasks for specialist roles, including multi-disciplinary approvals–mandating line-management teams to follow only pre-configured processes, so you spend significantly less time chasing personnel to complete their tasks.
  • Information Flow Design. Design the workflow so each person has exactly the right data available to them to carry out tasks within your workflows. Individual digitally signed reports provide an automatic audit trail showing the data that was available to the person that completed each task.
  • Activity Process Management Design. Spend less time dealing with common issues by making automated decisions based on real-time deep-analysis of task reports.
  • Automatic Validation. With in-built validation, all process flows can be mapped, confirmed, and automatically validated, allowing you to make 21 CFR Part 11 and Annex 11 compliant changes in days—rather than weeks to months and helps you optimize your processes.

 

BEST Analytics and Reporting

Best Analytics and Reporting - QMSVERTHOS QMS provides the four major categories of integrated analytics and reports: Operational management reports identify process bottlenecks and people who are not fully engaged, trend reports show efficacy of your processes, the real-time analytics dashboards let you slice your data exactly as you prefer, and the individual task reports provide a perfect evidence trail.  Features include:

  • Digitally signed task report PDF. VERTHOS QMS automatically produces a digitally signed tamper-proof PDF report for each user task in your workflows. It doubles as your comprehensive audit trail of all tasks.
  • One-click Task Context. You are always “audit-ready”, and just one mouse-click away from seeing the full context of any task displayed in a graphical hierarchy.
  • Bi-Directional Excel Spreadsheet Templates. Upload your own Excel spreadsheets into the system, define which fields are dynamic—and the system will automatically maintain and update the data on-demand (versus other systems that require manual exports each time and only generate static reports).
  • Report Redaction. Create multiple variants of any report that automatically exclude report sections that you do not wish to share. Protect confidentiality and trade secrets by only sharing the data needed by the recipient.
  • Composite Reports. Get a single overview report that automatically combines select data from multiple related reports—helps you easily see the big picture for any process.
  • Process Task Hierarchy. VERTHOS QMS provides a graphical hierarchical overview of every process that lets you see each task, including who, why and when it was assigned, plus a digitally signed task report so you are always audit-ready.
  • Analytics Dashboards. Create your own analytics dashboards with just a few clicks to visualize your data in pie, bar and line charts and in interactive hierarchy trees allowing you to identify risk in real-time.
  • Interactive Analytics. All charts (pie, bar, line and hierarchy trees) are fully interactive showing the underlying digitally signed task reports with a single mouse-click–providing confidence that reports and statistics are connected and verifiable.
  • Operational Management Reports. VERTHOS QMS automatically generates operational management reports that include a fully aged analysis by process and task type, helping you to identify process bottlenecks and people who are not fully engaged.
  • Trend Analysis Templates. Create your own custom templates that run automatically and perform deep-dive trend analysis across multiple aspects of your data allowing you to easily measure the effectiveness of your compliance, risk and quality efforts.

FULLY mobile

FULLY mobile - QMSVERTHOS QMS was optimized for mobility—including on and offline access (unlike legacy apps that use heavy VPNs, browsers or email to simulate mobile access). Every type of task or process looks and works identically on your desktop, tablet and phone. Mobile features include:

  • Synchronized Devices. Each of the devices is synchronized from the same database, so you can move seamlessly between mobile and desktop–picking up precisely where you left off.
  • Work Off-line. Unlike other applications that require a constant internet connection, VERTHOS QMS allows you to work off-line and automatically synchronizes your data once the internet becomes available–perfect for carrying out audits and investigations in remote areas with no cell or network access.
  • Standard Internet Connectivity. Uses encrypted internet connectivity without the need for VPNs (or importing/exporting email data). Perfect for situations where access to a VPN may not be available, particularly remote third-party sites, or when travelling.

 

EASIEST integration

EASIEST integration - QMSVERTHOS QMS was built to integrate.  All of the user applications use the same API (Application Program Interface) that is also available to your internal team. Key aspects include:

  • Restful API. VERTHOS QMS provides a comprehensive Restful API, that supports all operational features, and can be readily integrated with other systems in your environment using open industry standard interfaces (HTTPS / SSL / JSON).
  • IoT Support. IoT devices can be readily integrated that can eliminate error-prone manual processes in favor of automated collection of data from IoT devices.
  • Custom Integration BOTS. VERTHOS QMS provides integration building blocks (BOTS) to integrate with external systems. These blocks operate as real users on the system, can take instruction from their schedule, and complete their tasks with digital signatures. You only need to make changes to the BOTS (which are highly accessible), without having to change anything on either VERTHOS QMS or your external legacy system.
  • Encryption. Uses industry standard SSL for secure encrypted communications, and all data is stored within an encrypted data store (unlike many systems that pass sensitive data via email), protecting your valuable data.

 

Price Performance LEADER

Price Performance LEADER - QMSVERTHOS QMS is all inclusive and is much less to purchase, setup and maintain than major alternatives.

  • No hidden costs—no surprises. VERTHOS QMS is delivered with all the expected features. Unlike several vendors that deliver a “competitive” bid for the software, but then charge you for the slightest changes which can often double or triple your original costs.
  • Less costly to customize & validate. Uses a modern, modular system that you can easily customize, configure and self-validate–saving you potentially tens of thousands in custom changes (EACH time) and delays. You are not at the mercy that new releases will break your custom development or your compliance to 21 CFR Part 11 and Annex 11.
  • Lower cost of ownership. VERTHOS QMS is modular allowing you to select the functionality you need, manage the associated costs and integrate easily with existing systems. Everything is included, no customization or validation charges, much cheaper to integrate. Large savings through extensive automation. Workflows that are a perfect-fit for your business requiring less management time to drive adoption.

 

Quality Processes

VERTHOS QMS comes preloaded with a rich suite of quality management processes that you can adjust to your precise needs, including all of the following processes:


All processes are directly definable by you, giving you the power to:

  • Adjust existing processes to meet your exact needs.
  • Add or remove processes.
  • Clone existing processes as a basis for creating brand-new processes.
  • Connect the outcome of one process to another process (for example, CAPA or Action Management).
  • Define process rules based upon a deep analysis of activity data that can trigger other processes and activities.
  • Allocate or restrict processes based on user roles that you define.
  • Define the data you wish to capture in each activity.

All processes have the ability to support multi-person approval phases.  VERTHOS QMS provides automatic validation capability for all user defined changes.

 

Role Management and Security

VERTHOS QMS gives you all of the tools you need to ensure that you can precisely control who gets access to each aspect of functionality.

All activities are tamper-proof.  Once an activity is started by one of your staff it is automatically locked-down to that staff member.  VERTHOS QMS will not allow anyone else to make changes to that activity.  Once the activity is signed-off by the staff member it can never be changed again, even by the staff member that performed the activity.

All completed activities are treated as valuable evidence and are automatically retained to provide a full audit trail of your quality management activities.

Dashboards

VERTHOS QMS provides dashboards where you can see a live feed of all aspects of your quality management activities at a glance.  All dashboards are user definable and can analyse both live and historical data.

The diagram below below shows an activity tree illustrating the entire handling of an audit that resulted in multiple CAPA actions.  Just clicking on any part of the tree will open a PDF report from the VERTHOS QMS secure cloud showing how that activity was handled.  You can even observe activities being conducted as they happen.

 

You can use the built-in analytics dashboard to query any aspect of your operations and to analyse trends.

All graphs and charts are interactive, so you can click on a segment of a pie chart or a column in a bar chart to see the underlying data and reports.

You can customise the dashboards with just a few mouse clicks allowing you to create new analyses on demand.

 

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