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Quality management made easy - with roXtra

Your QM system in just one software.
All standards, all sectors.
Paperless and efficient.

Quality management made easy
- with roXtra

Your QM system in just one software.
All standards, all sectors.
Paperless and efficient.

QM made easy

Your QM system in just one software.
All standards, all sectors.
Paperless and efficient.

reference logo TUEV Sued

Continental reference logo

Reference logo Asklepios

Ehrmann reference logo

reference logo TUEV Sued

Reference logo Asklepios

Document control

Manage quality management documents in accordance with standards
and in individually defined workflows.

Learn more ...

Process management

Digitize and automate business processes
- across departments and locations.

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Risk management

Monitor and analyze risks in accordance with standards.

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Audit management

Manage audits effectively for sustainable success.

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Action management

Control measures centrally for continuous improvement.

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Electronic QM manual

Documentation of processes
Reference book

Simple, intuitive operation

Familiar folder structure
Layout as in Office

Support for all standards

ISO 9001, ISO 13485, and many more.
Integrated management system

Customer-oriented service

Personal contact person
Direct support

Configurable workflow

Individual processes
Audit trail

Practical full text search

All content searchable
Manage knowledge centrally

Transparent teamwork

Reminders & resubmissions
Clear responsibilities

Flexible assignment of rights

Individual rights
Cross-system data

Secure, web-based access

Location-independent
Regular safety tests

Get to know roXtra in a free and non-binding online presentation.

Get to know roXtra in a free and non-binding online presentation.

> Find central knowledge

With roXtra, you can manage all important company processes centrally, including existing knowledge and relevant information.

Thanks to the powerful full-text search, every user can immediately find the document they need. The software searches both the metadata and the content of the documents to which the employee has access rights.

The process list can be used to search for and filter processes in each module.

Would you like to derive direct measures from a risk analysis or an audit? With roXtra, you can create these without media discontinuity and immediately define a processor. Internal links ensure that stored data can be retrieved at any time.

The web-based application enables access to all digital documents, such as the QM manual, at any time and from any location. A wide range of interfaces also ensure fast and reliable data exchange.

> All standards, all sectors

With roXtra, workflows and processes can be flexibly configured to meet the specific needs and requirements of your company. This includes all standards and regulations, such as ISO 9001, ISO 13485, KTQ and software validation for GxP-regulated companies.

Whether small and medium-sized enterprises (SMEs) or international corporations - roXtra supports almost all sectors, from healthcare to manufacturing.

Find out more about our reference customers here.

> Integrated management system

roXtra enables the implementation of many other management systems as well as the transparent mapping of a comprehensive integrated management system (IMS). The software links areas such as quality management (ISO 9001), environmental management (ISO 14001), energy management (ISO 50001) and occupational health and safety (ISO 45001).

In addition, roXtra supports you in complying with the General Data Protection Regulation (GDPR) and compliance guidelines so that all requirements are reliably met.

> User management

User and rights management for web-based software is often one of the most error-prone processes. As a company and its IT landscape grow, user management becomes increasingly complex. With roXtra's cross-system and efficient user management, you always have an overview and can easily define individual rights.

Interface connections to various identity providers (such as Active Directory, Entra ID or Okta) make it easy to transfer and maintain user master data from other systems, especially for systems with a large number of users. Define all access, editing and release rights individually and organize your users by area, for example by department.

> Certification

ISO 9001:2015 stipulates complete documentation and control of information. Creating and maintaining quality management documentation is therefore one of the most important tasks and functions of QM software.

roXtra supports you in setting up a digital QM manual and in the standard-compliant management of your documents throughout the entire life cycle - from creation to revision, distribution to the relevant persons or groups and archiving.

For upcoming audits and certifications, the documents and all revisions can be clearly traced. So nothing stands in the way of your successful ISO certification!

By the way: At Roxtra, we don't just talk about quality management, we live it and are ISO 9001 certified ourselves! Our ISO 9001:2015 certificate

> Transparency &Teamwork

Efficient teamwork and transparent work processes are crucial to a company's success. With roXtra, tasks are generated automatically and distributed directly to the responsible person. This ensures that no task is overlooked and every employee knows exactly what they are responsible for.

To check the validity of your processes, you can store corresponding resubmissions. This ensures that your documents and processes are always up to date in line with the continuous improvement process (CIP). The person responsible is informed so that all team members know the current status of their tasks at all times.

> CIP

In addition to QM planning, the continuous improvement process (CIP) is also an important part of QM. DIN EN ISO 9001 defines continuous improvement as one of the seven principles of quality management. It serves to uncover potential for improvement in processes or products and to develop plans for the corresponding implementation.

The CIP is never complete, but is applied again and again in cycles. The method is based on the PDCA cycle (Plan, Do, Check, Act): the observation of processes, the analysis of weak points and ultimately the development of solutions for improvement and optimization.

roXtra helps you to identify potential weaknesses, improve existing processes and introduce these improvements as a standardized way of working throughout the company.

> Structure business processes

Mapping business processes creates transparency: process maps provide an overview of all core elements and supporting processes and illustrate how they are linked to each other.

With the Flowchart Designer, you can create transparent representations of your operational processes, organization charts, turtle models, etc. in no time at all. This allows you to easily structure and organize your business processes and make them accessible to all those involved. The Flowchart Designer also provides support for standard-compliant QM documentation.

Are you looking for a tool to automate business processes? Get to know roXtra processes!

With roXtra, the electronic mapping and automatic execution of business processes and procedures is simple: thanks to process modeling based on BPMN 2.0, roXtra supports you in presenting processes clearly and concisely. Forms can also be filled out and processed paperlessly.

This allows a wide variety of processes to be mapped digitally, such as orders, CAPA, CIP, measures, vacation requests and more.

> Hosting

As a customer, you decide whether you want to use the roXtra QM software as Software-as-a-Service (SaaS) or hosted locally (on-premise). Please note that the roXtra software is developed and hosted in Germany.

Regardless of which model you choose, security is our top priority: with regular penetration tests (pentests) and security checks, we guarantee the protection of your data and aim to meet the highest security standards.

Is hosting your SaaS solution in accordance with the C5 standard of the German Federal Office for Information Security (BSI) relevant for you? Contact us to find out more.

roXtra QM software is hosted in Germany
roXtra QM software is developed in Germany

What is a quality management system (QMS)?

A quality management system (QMS) should ensure consistent product and service quality, which increases customer satisfaction and strengthens the market position. It helps to optimize operational processes, reduce costs and increase efficiency. In addition, a QMS supports compliance with legal and regulatory requirements, minimizing risks and protecting the company's reputation.

Why do you have to do QM?

The simplest answer: Because there is a regulation.
Companies in certain sectors are obliged to provide evidence of a QMS. However, standard requirements, certifications and audits pose a major challenge for companies, especially for the quality management representative (QMB). Especially when working with not one, but several software solutions.

Why should I do QM?

Certified companies (for example according to DIN EN ISO 9001) have a large number of documents that need to be managed. Document control is a central component of this standard and ensures that all documents relevant to quality assurance are managed systematically. The aim is to ensure transparency of product and service quality. 

Would you like to find out more about roXtra?

We will be happy to advise you!

Would you like to find out more about roXtra?
We would be happy to advise you!

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