QM Software for the Pharmaceutical and Medical Technology Industries
QM software for the pharmaceutical and medical technology industries
The QM system for the most stringent regulatory requirements
When audits and regulatory requirements dictate daily operations, you need a quality management system that provides peace of mind. For more than 25 years, roXtra has been helping companies in the pharmaceutical and medical technology sectors manage their documents and processes in compliance with standards—making it one of the leading solutions for professional quality management in highly regulated industries.
Why is roXtra the right QM software for the pharmaceutical and medical technology industries?
roXtra is specifically designed to meet the practical needs of organizations in the medical technology and pharmaceutical sectors—while offering maximum flexibility.
Whether you operate a single location or a group of companies, our QM software scales with your needs and enables consistent, cross-location management and continuous improvement of your quality processes.
Safety Through Audits and Inspections
roXtra centralizes all quality-related documents and processes in one place. Automated workflows reliably route reviews and approvals to the right people, and changes are fully documented. This ensures you’re always prepared to provide information—even for last-minute audits.
Audit-proof documentation
Our QM software is validatable and designed to meet all complex regulatory requirements (e.g., GMP and MDR). Versioning, approvals, and changes are tracked transparently within roXtra, while audit trails, role-based access controls, and audit-proof archiving ensure transparency and security.
Data Protection & IT Security
roXtra is hosted in a German data center that is ISO 27001-certified and BSI C5-compliant. The solution is GDPR-compliant and meets stringent requirements for data protection, data security, and compliance in regulated environments.
Manage measures and risks in a structured manner
roXtra guides you through CAPA and non-conformance processes with clear workflows. Responsibilities, deadlines, and actions are clearly defined, and their status is visible at all times. This ensures that actions are effectively implemented and consistently tracked.
Safety for users
Employees always work with approved and up-to-date SOPs and guidelines. Changes are communicated transparently, and responsibilities are clearly defined. This reduces errors in day-to-day operations and enhances safety for patients, products, and users.
AI Support with roXi: Less Effort, Faster Results
Our platform is a forward-looking solution that is continuously being developed. The integration of AI features helps you automate processes, perform intelligent document searches, and optimize workflows.
Schedule an appointment online now
Before we go on and on about it, we’d rather give you a firsthand look. In a no-obligation online presentation, we’ll give you a hands-on introduction to roXtra—and show you how it can make your day-to-day work easier.
Schedule an appointment online now
Before we go on and on about it, we’d rather give you a firsthand look. In a no-obligation online presentation, we’ll give you a hands-on introduction to roXtra—and show you how it can make your day-to-day work easier.
With these roXtra solutions, you’ll have your quality management firmly under control
Digital Document Management – Clear and Secure
Keep your quality-related documents easily under control: All content is stored in one central location, clearly versioned, and properly approved. This way, everyone involved can immediately see what is currently in effect and what is no longer valid. Changes are documented in a traceable manner, and older versions are securely archived. This provides clarity in day-to-day operations and offers peace of mind when audits or inspections are scheduled.
Your advantages
- Clear roles and transparent responsibilities
- Automated workflows for documents and approvals
- Intuitive operation for different user groups
- Complete version control and change logs
- Audit trail and extended read receipts
roXtra Processes Transparent Workflows for Medical Technology and Pharmaceuticals
With roXtra Processes , you roXtra Processes your business processes digitally and transparently. Whether it’s CAPA, complaint management, or vacation requests—processes can be easily modeled, automated, and flexibly customized without integrating additional systems.
Typical applications
- CAPA, Nonconformance, and Complaint Processes
- Release and Approval Procedures in the GxP Environment
- Hygiene, Safety, and Compliance Audits
- Administrative processes such as vacation or training requests
Key Features
- Graphical Process Modeling According to BPMN 2.0
- Electronic forms and automated workflows
- End-to-end digital process chains
- Integration with existing ERP, CRM, and Office systems
New: AI Process Generator
Our AI generates complete BPMN processes at the click of a button. Describe your workflow or enter an existing process description, and roXi will generate logical workflows, including fields and roles.
Successfully Managing Risks, Audits, and Measures
Risk Management for Informed Decisions
Using a centralized tool, you can identify and assess all relevant risks and develop appropriate measures based on them.
Your advantages
- Structured identification and assessment of quality-related risks
- Support for patient, user, and product safety
- Coverage of process, compliance, IT, and data protection risks
- Compliance with standards such as ISO 31000
- Direct identification of actions and opportunities
Effectively manage and track initiatives
With roXtra, you can plan, manage, and document quality-related measures in a centralized and traceable manner. Responsibilities, deadlines, and statuses are transparent at all times, ensuring that measures are consistently implemented and their effectiveness can be verified.
Your advantages
- Centralized recording and tracking of all measures
- Direct derivation of CAPA actions from processes, risks, and audits
- Documented effectiveness testing and informative reports
- Clear lines of responsibility across departments and locations
Conduct audits in a structured and secure manner
roXtra makes your audit management clear and simple, so you're always prepared for audits.
Your advantages
- Support for relevant standards such as ISO 9001, ISO 13485, and ISO/IEC 17025
- GxP-compliant system architecture, including validation support
- Audits can be conducted remotely and offline
- Complete audit trails
- Direct derivation and tracking of actions
With these roXtra solutions, you’ll have your quality management firmly under control
Simple, digital document management
With roXtra, organizations in the medical and pharmaceutical sectors can manage their quality-related documents centrally, securely, and entirely digitally. From automatic versioning and controlled approval processes to documented read receipts, the entire document lifecycle is mapped transparently. SOPs, procedural instructions, guidelines, hygiene requirements, work instructions, and checklists are always up to date, archived in an audit-proof manner, and available without media breaks.
Follow-up reminders and notification functions ensure that content is reviewed on time and updated regularly.
✔️ Clear roles, responsibilities, and transparency
✔️ Digital and automated workflows
✔️ Intuitive usability for all user groups
✔️ Comprehensive version control and change logs
✔️ Audit trail and advanced read receipts
roXtra Processes a module for a wide range of applications in medical technology and the pharmaceutical industry
With roXtra Processes , you roXtra Processes quality-related and administrative processes exactly as they are carried out in your organization. Whether for CAPA processes, change control, internal approvals, or complaint management, roXtra enables structured, digital, and traceable management of all workflows. Processes can be easily modeled, automated, and adapted to new regulatory or organizational requirements at any time without the need for additional systems.
Typical applications
✔️ Digital management of CAPA, nonconformity, and complaint processes
✔️ Release and approval procedures in the GxP environment
✔️ Hygiene, safety, and compliance inspections
✔️ Administrative processes such as vacation or training requests
Key Features
✔️ Integration with existing ERP, CRM, and Office systems
✔️ Graphical process modeling according to BPMN 2.0
✔️ Electronic forms and automated workflows
✔️ End-to-end, fully digital process chains
New: AI Process Generator
Our AI generates complete BPMN processes at the click of a button. Describe your workflow or enter an existing process description, and roXi will generate logical workflows, including fields and roles.
Successfully Managing Risks, Audits, and Measures
Risk Management for Transparent Decision-Making
With roXtra, you can centrally capture, assess, and manage risks within a structured system. Risks related to processes, products, IT, or organizational structure are documented in a traceable manner and linked to specific mitigation measures. This enables you to establish a robust foundation for compliance, quality improvement, and confident decision-making in a regulated environment.
✔️ Maintaining and improving patient safety, e.g., by preventing medical errors
✔️ Addressing all compliance, medical, IT, and data protection risks (including ISO 31000 and KRITIS)
✔️ Improving the quality of care through early detection of process gaps
✔️ Directly identifying opportunities and actions based on the risk management system
Plan measures easily and implement them sustainably
Clearly assign tasks, set deadlines, and track progress in real time.
✔️ Centralized recording and management of all actions
✔️ Creation of (CAPA) actions directly from the Processes/Risks/Audits modules
✔️ Automatic effectiveness checks, reports (Excel/Word/PDF), and comprehensive documentation
✔️ Transparent assignment of responsibilities for wards, departments, and divisions
Is your next audit coming up? No problem.
roXtra makes your audit management clear and simple, so you're always prepared for audits.
✔️ Audit-ready for ISO 9001, ISO 13485, DIN EN ISO/IEC 17025, ISO 14001, KTQ, G-BA, etc.
✔️ GxP-compliant delivery and validation support
✔️ Can be performed remotely and offline
✔️ Complete audit trails
✔️ Direct derivation of corrective actions
Find out more about the AI possibilities in roXtra
roXtra opens up new possibilities for you: Thanks to our intelligent assistant roXi, you can find exactly the information you need in no time. Or use the AI Hub and an API interface to easily and securely integrate your own AI systems into roXtra—always up to date and always compliant with data protection regulations. Our team would be happy to show you in a personalized online session how you can take your quality management to the next level by leveraging artificial intelligence in roXtra.
Customer Reviews and Experiences with roXtra
Customer Stories
Answers to your most important questions
Which QM software is best suited for the pharmaceutical and medical technology industries?
Suitable QM software for the pharmaceutical and medical device industries helps organizations implement regulatory requirements in a secure and traceable manner. This includes, among other things, GxP guidelines, GMP, GDP, ISO standards, the MDR, as well as regulations governing pharmacies and pharmaceuticals.
Other key factors include robust IT security, GDPR compliance, and ease of use for different user groups. Integrated solutions that combine core quality management tasks—such as document control, processes, risks, audits, and corrective action management—into a single system have proven effective. This results in a transparent quality management system that works effectively in day-to-day operations and reliably stands up to audits.
What standards and requirements does roXtra support?
roXtra works across standards and industries. The software is not limited to specific standards but supports the implementation and operation of integrated management systems.
Typical applications include:
- Quality management (e.g., ISO 9001, DIN EN ISO 13485, EN 9100)
- Environmental and Sustainability Management (e.g., ISO 14001)
- Risk and Compliance Management (e.g., ISO 31000, ISO 14971, ICH Q9)
- Information Security Management (e.g., ISO/IEC 27001, GDPR-compliant data processing)
- Legal, regulatory, and internal requirements (e.g., industry-specific requirements, GxP including GMP and GDP, MDR, AMG, ApBetrO, customer requirements, internal guidelines)
Is your certification or regulatory requirement not listed? Feel free to contact us. Together, we’ll explore how roXtra can best support your specific needs.
Where is the roXtra QM system hosted?
As a customer, you decide whether you want to use the roXtra QM software as Software-as-a-Service (SaaS) or hosted locally at your site (on-premise). The software itself is developed and hosted in Germany. You can find all the information about your usage options here.
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 Federal Office for Information Security (BSI) relevant to you?Contact us to learn more.
Is roXtra suitable for use in a GxP environment?
Yes. roXtra is designed for use in regulated environments and supports GxP-compliant processes such as document control, CAPA management, audit management, and risk management. Audit-proof documentation, clear role models, and audit trails ensure traceability and compliance.
Is roXtra validatable?
roXtra is designed to be validation-ready and supports companies in the validation of computer-based systems. Its system architecture, logging, authorization concepts, and documentation provide a robust foundation for risk-based validation in accordance with GxP requirements. For more information, visit: https://www.roxtra.com/gxp/
What company sizes is roXtra suitable for?
roXtra is scalable and is suitable for small pharmacies and businesses as well as for medium-sized and international companies in the pharmaceutical and medical technology industries. It can flexibly support multi-tiered organizational structures and cross-location processes.
How complex is the implementation of roXtra?
The rollout of roXtra is phased and practical. Companies can start with individual modules and expand the solution as needed. roXtra supports you throughout the implementation process and ensures that the solution quickly delivers value—without the need for complex or high-risk IT projects.
Why getting started with us is so easy:
- A phased rollout instead of a years-long quality management project
- Ready to go with tried-and-tested QM templates—no need for a months-long planning phase
- Guided tour & personal contact person
- Practical support instead of waiting on hold
- Minimal IT effort, no programming required
- First usable results early in the project
Who roXtra is particularly well-suited for in the pharmaceutical and medical technology sectors
Pharmacies and pharmacy chains
Pharmaceutical Manufacturers & Pharmacy
Contract,
Testing and Quality Control Laboratories
Medical technology and products company
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