The QM solution for pharmaceutical manufacturers

Effective document control with roXtra

In the pharmaceutical industry, high quality and safety standards are essential in order to meet legal requirements and ensure consistently high product quality. Regulations such as Good Manufacturing Practice (GMP), ISO 9001 or ISO 13485 require structured and reliable pharmaceutical quality management.

With the roXtra document control module, you can efficiently manage your QM documentation - from standard operating procedures (SOPs) to hygiene specifications and test protocols. Our software accompanies the entire life cycle of your documents and ensures that all relevant regulations are implemented in accordance with the rules - even in the GMP environment.

Your advantages with roXtra in the area of document control:

• Individual approval workflows: Customizable to your processes and standard requirements.
• Audit-proof versioning: automatic storage and archiving.
• Rule-compliant document management: For all guidelines, including in the GMP environment.
• Rely on a future-proof software solution to make quality management in pharmaceutical production efficient, compliant and transparent.

Efficient and digital process management

Optimize your internal processes with a digital solution for quality management in the pharmaceutical industry. The roXtra Processes module makes it easy to model and control workflows - from production to hygiene and quality inspections through to complaints management.

Thanks to an intuitive graphical interface, rules, responsibilities and tasks can be clearly defined for all relevant processes. This ensures efficient implementation of pharmaceutical quality management requirements and ensures that all regulatory requirements are met. We supply you with roXtra as a GxP-compliant standard version and support you in designing transparent, secure and efficient processes.

With the Flowchart Designer, you can create simple models such as flowcharts, organization charts or mind maps in no time at all and make your processes easy to understand for everyone involved.

With the Flowchart Designer, you can create simple models such as flowcharts, organization charts or mind maps in no time at all and make your processes easy to understand for everyone involved.

Advantages of process management with roXtra:

• Transparency and clarity: Visualization of complex procedures such as production processes and quality inspections.
• Continuous improvement (CIP): Optimize processes and make them sustainably efficient.
• User-friendliness: Intuitive design and fast implementation of your requirements.

Effective risk management for maximum safety

With roXtra Risks you can optimize your quality management and reduce the effort involved in risk management. Identify, analyze and manage potential risks centrally to ensure quality and safety. roXtra supports you in complying with regulatory requirements such as GMP, ISO 9001 and ISO 13485 and facilitates the implementation of effective quality management in the pharmaceutical industry.

Regulations require well thought-out risk management in order to identify potential risks - such as quality deviations in production or hygiene defects - at an early stage. With roXtra, you can systematically assess risks, manage preventive measures and continuously improve your QM processes. Rely on reliable GMP-compliant software to minimize risks and efficiently meet regulatory requirements.

Effective audit management for pharmaceutical manufacturers with roXtra Audits

Audits are an essential part of pharmaceutical quality management in order to check manufacturing processes, identify deviations and enable continuous improvements.

With the module roXtra Audits module allows you to plan, document and manage internal and external audits in a structured manner. The software also supports you in the GxP/GMP environment in transparently controlling audit processes as part of quality management in the pharmaceutical industry, directly deriving measures and seamlessly tracking their implementation.

Your advantages with roXtra Audits:

• Efficiency and transparency: Document and initiate immediate, corrective and preventive measures directly in the context of the audit.
• Systematic implementation: Access your questionnaire from any location - even offline.
• Optimized planning: Maintain an overview of past, current and planned audits.