Software > Business Management > Document Management Systems (DMS) > roXtra
The software for your digital quality management


The software for your digital quality management

Version:  9

Demo version

With our solutions and individually configurable modules, you can optimally adapt the QM system to your requirements and needs:


In roXtra Documents, benefit from the user-friendly and intuitive user interface as well as an individual document workflow with clear and transparent release and steering processes as well as the automatic and audit-proof versioning and archiving of your QM documents. Thanks to the fast and integrated full-text search, you always have an overview of where which document is located. With roXtra, steering and controlling is easy - and throughout the entire document lifecycle for all guidelines and requirements such as ISO 9001:2015, ISO 13485:2016 as well as in the GxP-regulated environment. You also have the option of visualising your business processes with the integrated flowchart designer and storing forms, documents and information directly from your roXtra documentation. So nothing stands in the way of a successful audit and ISO certification!

No more paper chaos! Make a sustainable contribution to the success of your company with digital document control!


roXtra Audits supports you from the planning of the inspection date and the implementation with the help of a questionnaire defined by you to the follow-up and evaluation of the results.


With the process management tool roXtra Processes you create digital forms easily and quickly. The module supports the intuitive creation of electronic input masks with form fields (e.g. checklists and dropdown fields) and the automation of already existing office forms. There are also numerous process templates for recurring processes such as complaints, CIPs, approvals and release processes, which you can adapt to your exact requirements in terms of content and form. In this way, you can quickly and conveniently digitalise your business processes and automate procedures.

Each electronic form represents its own process. BPMN 2.0 makes it easy and intuitive to graphically model processes and create electronic forms. Defined, logical rules and responsibilities for individual procedures and tasks of a process, as well as automatic notifications, create transparency for all those involved in the process.


The QM software roXtra supports you in limiting the required effort for your company-wide risk management and still fulfilling the legal requirements (e.g. according to ISO 31000, ISO 15224, ISO 9001 and ISO 80001-1) at the same time. roXtra Risks helps with the identification, with the qualitative risk analysis as well as with the management of the risks of your organisation. The risk management solution records and documents all incidents in accordance with the rules and supports the evaluation of corrective measures. Use the software to ensure transparency across the entire risk situation and lay the foundation for effective and efficient preventive measures.

Following the risk analysis, you can define appropriate measures and document them directly in the respective risk. By integrating the roXtra Processes module, you can also create individual measure processes and link them with each other.


roXtra takes contract management to a whole new level and supports you in the structured, secure and digital management of your contracts - from contract entry to deadline monitoring to audit-proof archiving. For each contract, you can store the essential metadata such as contract type, contract partner and contract number. Corresponding financial flows can be easily maintained and continuously displayed: roXtra shows which costs are incurred for a contract over the entire term. In comprehensive reports you can have statistics on all contract documents displayed in roXtra. This way you always have an overview of all deadlines and costs.


roXtra GxP supports the mapping of provisions of common national and international regulations and guidelines that are required of software to support QM documentation. These include, for example, the German Medicines Act (AMG), the German Medical Devices Act (MPG), the EU GMP guidelines (in particular Annex 11 and Annex 15), the guidelines of the German Medical Association (Rili-BÄK), the Code of Federal Regulations (in particular 21 CFR Part 11 and 21 CFR Part 820) and the GAMP 5 guidelines.


Active Directory
Azure AD

Target groups:

roXtra is used by companies of all sizes and industries due to its high scalability and adaptability.


Find out more about our references from a wide range of industries at

Contact information:
Mr. Marc Schukey
0049 (0)7161 505700
Links & Downloads:
direct to webpage
Success story
direct to webpage
Software exposé
request URL

Functions (excerpt) of roXtra:

8D report
Filing structures
Change documentation
Change logs
Change tracking
Creation and deletion of documents
API interfaces
Occupational safety
Archive access rights
Auditfunction signature
Audit management
Task generation
Task management
Task tracking
Processing status
Notification system
User and time stamp
Range search
Report management
Assessment tools
Assessment forms
Evaluation catalogs
BPMN 2.0 workflows
Fire protection documentation
Opportunity management
Change management
Compliance management
File archiving
Database interfaces
Data maintenance
Digital stationery
Document signatures
Documentation of QM
Documentation systems
Document workflow
Document archiving
Document input
Document indexing
Document classification
Document control
Document stamp
Document templates
E-mail alerts
E-mail notification
E-mail functions
E-mail integration
E-Mail dispatch
Probabilities of occurrence
Recording reasons
Reminder and escalation functions
Reminder functions
Export functions
External parties
Favorites management
FMEA Forms
Form and document processing
Import functions
Industry standards
Content overview
Table of contents creation
Internal communication
Inspection management
Internal audit functions
internal control systems
ISO standard management
Classification systems
Comment function
Control plan
Header and footer texts
Corrective and preventive actions
Corrective actions
Supplier audits
Supplier evaluation
Supplier qualification
Logos and signatures
Measures export and import
Measures management
Measures status query
Measures overview
Action tracking
Multi-user capability
Multiple links
Metadata search
Modeling workflow
Sample letters, contracts
Sample contracts
Sample templates
Message system
norms and standards
Standards, catalogs and pipe classes
Standards compliance
Outlook integration
PDF Viewer
PDF file
PDF creation
Process and form design
Process reporting
Process documentation
Process management
Inspection reports
Inspection plans
Inspection plan versioning
Ranking of risks
Legally compliant archiving
Risk assessment
Risk cockpit
Risk categories
Risk control
Risk map
Risk management
Risk control measures
Risk types
Self Sorting List
Backup and archiving
Language versions
Status changes
Search strategies
Template-based document creation
Deadline and time limit monitoring
Text editing
Text filter
Text templates, sample texts
Top risks
Trend analyses
Translation assistance
Monitoring of workflows
Contract approval workflow
Contract type definition
Contract controlling
Contract management
Full text search
Full text translation
Template management
Probability distributions
Maintenance contracts
recurring risks
Workflow management
Workflow optimization
Workflow status
Scheduled workflows
Time series analyses
Access rights
"on the fly" changes


from 2,500.00
plus 19% VAT

Get to know the software better! Request a video appointment for a personal presentation!

Technical specifications:

SaaS, Cloud:
Multi-user (network-compatible):
Multi-client compatible:
for a fee
on request
Manufacturer based in:
for a fee
for a fee
Installation support:
for a fee
Manual, Online Help, Demo version, Technical documentation
Dialogue language(s):
English, German, French
System requirements:
Compatible operating systems (runs with):
Win 11
Win 10
Win Server
Mainframe based
Unix based
Linux based
Mac OS
Mobile OSs (supports):
Old Compatible Operating Systems:
Win 8
Win 7
Win Vista
Win XP
Win 9x/ME
data storage medium:
Flash memory
Other requirements for soft- and hardware:
Web-based system: Operation via Internet Explorer from version 11, Mozilla Firefox, Google Chrome and Microsoft Edge (Chromium).