The QM Solution for Drug Manufacturers
The QM Solution for Drug Manufacturers
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Find out first-hand how pharmaceutical manufacturers use roXtra to make their pharmaceutical quality management efficient and compliant. Whether GMP guidelines, ISO 9001 or ISO 13485 - roXtra offers specially developed solutions for quality management in the pharmaceutical industry.
In our blog, you can find out more about certification and re-certification, the implementation of pharmaceutical quality management in practice and practical application examples from the industry. Discover how our software can help you to reliably meet regulatory requirements and optimize processes.
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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 roXtra Audits module, internal and external audits can be planned, documented and managed 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.
Action management in the pharmaceutical industry
Effective action management is a central component of quality management in the pharmaceutical industry in order to identify deviations at an early stage, minimize risks in a targeted manner and reliably meet legal requirements - for example in accordance with ISO 9001 or GMP. With roXtra Measures, immediate, corrective and preventive actions (CAPA) can be systematically planned, controlled and fully documented.
Roxtra's software ensures transparent tracking of all measures - even in a GxP/GMP-regulated environment - and thus supports the sustainable optimization of your processes. This not only strengthens your pharmaceutical quality management, but also ensures compliance with all relevant regulatory requirements.
Your advantages with roXtra measures:
- Central management: Clearly record and control all measures.
- Automatic effectiveness check: Sustainable implementation through planned checks.
- Simple evaluation: Filter lists of measures and export them as Excel, Word or PDF.
- Cross-module: Linking for consistent documentation.
Support for certifications and QM for pharmaceutical manufacturers
Our software solutions make your daily operations as well as the certification and re-certification of your quality management system (QMS) easier. With roXtra, you can implement a wide range of standards and regulations efficiently and in compliance with the rules - from ISO 9001 to ISO 27001.
Quality management for pharmaceutical manufacturers
- Guidelines of the German Medical Association (Rili-BÄK)
- U-GMP Guideline - Principles and Guidelines of Good Manufacturing Practice for Medicinal Products
(Good Manufacturing Practice, GMP) - Annex 11 - Guideline ICH Q10 Pharmaceutical Quality System
- Pharmacy operating regulations - quality management system (§ 2a ApBetrO) and for the manufacture of patient-specific parenteral medicinal products (§ 35 ApBetrO)
- Medicinal Products Act - Production of medicinal products (Sections 13 to 20a AMG) and quality assurance and control (Sections 54 to 55a AMG)
- Ordinance on the Manufacture of Pharmaceuticals and Active Pharmaceutical Ingredients (AMWHV)
- Operating Ordinance for Pharmaceutical Companies (PharmBetrV)
- EMA (European Medicines Agency) guidelines and recommendations
- Regulations of the Food and Drug Administration (FDA) - Food and Drug Administration of the United States
- Standard Operating Procedures (SOPs) - standardized procedures of processes in critical areas of the pharmaceutical industry
- Regulations of the Federal Institute for Drugs and Medical Devices (BfArM)
Risk management and security
- DIN EN ISO 31000: Guidelines for risk management
- ONR 49000 / ONR 49001: Austrian risk management standards
- IEC 80001: Risk management for networked medical technology
- KonTraG and Section 91 (2) AktG: Establishment of a risk management system (RMS) in the corporate sector and for listed companies
Quality management in general
- DIN EN ISO 9000 series of standards: Quality management standards
- DIN EN ISO 9001: Quality management systems
- ISO 27001: Information security management system (ISMS) and IT security
One software, many application areas.
What is pharmaceutical quality management?
Pharmaceutical quality management refers to all systematic measures aimed at ensuring the quality, safety and efficacy of medicinal products throughout the entire manufacturing and distribution chain. It includes processes such as document control, risk management, audits and CAPA as well as compliance with regulatory requirements such as GMP (Good Manufacturing Practice).
Why is quality management so important in the pharmaceutical sector?
Quality management is essential to guarantee patient safety, meet regulatory requirements and ensure consistently high product quality. In the pharmaceutical industry, errors can have serious consequences - which is why structured QM systems and seamless documentation are essential.
What role does GxP or GMP software play in pharmaceutical quality management?
GMP software supports pharmaceutical manufacturers in complying with legal regulations and standards through digital, traceable processes. It helps to manage QM documents, processes, audits, risks and measures in a structured manner and to document them in an audit-proof manner - a central building block for efficient and compliant quality management in the pharmaceutical industry.
roXtra supports you with the following solutions:
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