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The QM Solution for your Pharmacy

  • Document control according to standards
  • Simple process automation
  • Easy operation & secure access

The QM Solution for your Pharmacy

An excerpt of our customers in the pharmaceutical industry

Customer testimonialn

References megapharm uses roXtra
References Bless You uses roXtra
References Acnos Pharma uses roXtra
References Noweda uses roXtra

roXtra supports you with the following solutions:

The roXtra Documents module for standard-compliant document management

Document Workflow

The roXtra Processes module for digitizing business processes

Process Management

The roXtra Actions module for controlling and monitoring actions

Action Management

The roXtra Risks module for digital risk monitoring

Risk Management

The roXtra Audits module for planning and documenting audits

Audit management

roXtra software in the field of pharmacies

Unlike other retail businesses, pharmacies are subject to strict legal regulations and must comply with special requirements and quality assurance measures that are regularly monitored by the relevant authorities. This is the only way to ensure a consistently high quality of drugs and medicines and thus the protection of customers. In addition, customers expect qualified advice on all aspects of medicines and health issues - from storage and administration to interactions and possible side effects or risks. Pharmacies are therefore legally obliged by various regulations, such as the Pharmacy Act (Apothekengesetz, ApoG) and the Pharmacy Operating Regulations (Apothekenbetriebsordnung, ApBetrO), to ensure the proper supply of medicines to the population. The regulations state that goods (medicines, hygiene products, etc.) and services (health examinations, pharmaceutical care, provision of medical aids, etc.) must be offered by pharmacies in the highest quality.

Since 2014, pharmacies have been required by the Pharmacy Operations Ordinance to operate a Quality Management System (QMS) "in accordance with the type and scope of pharmaceutical activities" (§ 2a Quality Management System - ApBetrO). In addition to the guarantee, this includes the production, testing and storage of medicinal products, as well as the control, optimisation and documentation of internal processes.

Our software solutions can be individually adapted to your needs.

This ensures both, user-friendliness and compliance with the provisions of common standard specifications (e.g. ISO 9001), the German Medicines Act, the Pharmacy Operating Regulations and the German Social Code (SGB) etc. 🗎Here you will find an overview of how the requirements of GxP regulations such as the EU EMP Guideline (Annex 11) and the guidelines of the German Medical Association (Rili-BÄK) are implemented in roXtra. In addition, we will be happy to support you during implementation, validation and throughout the entire system operation.

DOCUMENTS

Pharmacies are obliged to record pharmaceutical activities, such as the manufacture, testing and storage of medicinal products, as well as regulations on work processes, in writing (§ 2a Pharmacy Operating Regulations).

roXtra Document Workflow is the perfect software solution to manage and archive your pharmacy's QM documents clearly, audit-proof and in accordance with regulatory requirements. Store relevant documents, such as regulations on hygiene measures, instructions for pharmaceutical staff, inventory for medical devices, and much more, centrally for your employees.

The roXtra Documents module for standard-compliant document management
PROCESSES

Digitize and automate your internal processes with the module roXtra Processes. With the graphical modelling (BPMN 2.0) you have the possibility to map and run through rules, responsibilities, tasks and input fields for different processes and forms (e.g. testing of finished medicinal products, rental of equipment etc.).

With the Flowchart-Designer you can visualize simple models - such as flowcharts, organigrams, mindmaps, etc. - in no time at all. Thus, the pharmaceutical processes of your pharmacy (drug transport, home care, design of the courier service, etc.) are easy to understand for your employees and can be continuously improved (CIP).

The roXtra Processes module for digitizing business processes
RISKS

With roXtra risks you can reduce the amount of work required for your cross-company risk management. Identify and manage potential risks centrally for an effective, qualitative risk analysis in your pharmacy. roXtra supports the current standards and regulations (e.g. ISO 31000 or ONR 49001, ISO 9001 and ISO 27001).

Pharmacies are legally obliged to ensure the proper supply of medicines to the population. Therefore, many regulations require a risk management system. Effective risk management supports the avoidance, reduction, optimisation and transfer of risks. In this way, you can prevent various risks (e.g. poor hygiene, drug spoilage, supply shortages of drugs, etc.) and prevent them in the future.

The roXtra Risks module for digital risk monitoring
AUDITS

Audits are an essential part of your work as a quality manager and internal auditor?
You know that systematic audit management is your most powerful tool as an auditor?

Increase the effectiveness and quality of your own work with the roXtra Audits module. The software supports you in auditing management systems according to the specifications such as those of ISO 19011.

Thanks to roXtra Audits, you work with a system and access the questionnaire for conducting audits regardless of location, even offline. In this way, you increase internal efficiency and diligence when conducting audits. At the same time, your team and you gain an overview of the status of past, current or pre-planned audits.
Focus on identifying internal nonconformities and areas for improvement. Defined immediate, corrective and preventive actions are documented and started directly in the context of the audit. No matter whether DIN EN ISO 9001, ISO 13485, DIN EN ISO/IEC 17025 or ISO 14001: roXtra helps you to meet the various requirements of current standards with flying colors in order to do a really good job.

The roXtra Audit module for planning and documenting audits
CERTIFICATION & STANDARDS

Our software solutions support you both, in daily pharmacy operations and during the certification and re-certification of your quality management system. With roXtra, the implementation of a multitude of standards and regulations becomes a breeze.

  • Implementation of the DIN EN ISO 9000 series of standards - quality management standard
  • Including DIN EN ISO 9001 - Quality management systems
  • DIN EN ISO 31000 - Guidelines for risk management
  • or ONR 49000 / ONR 49001 - Austrian risk management standard
  • Quality certificate of the Chamber of Pharmacists
  • QM statutes of the Chamber of Pharmacists
  • QM guidelines of the Federal Chamber of Pharmacists (BAK)
  • Pharmacy operating regulations - § 2a Quality management system (ApBetrO)
  • BAK quality seal
  • ISO 27001 - Information Security Management System (ISMS) / IT Security
  • KonTraG - Law on Control and Transparency in the Corporate Sector (Corporate Governance)
  • Section 91 (2) AktG - Establishment of a risk management system (RMS) for listed companies
Certification and standards at roXtra

success stories

We can tell you a lot of things...

...that's why we give our users a voice. In this way, you receive first-hand reports directly from the field. Branch pharmacies, pharmacy chains as well as mail order pharmacies can fall back on a location-independent QM software with roXtra. See for yourself and learn more about the use of roXtra in a wide variety of areas.

  • In the service of patients
    Together with the Rennbahnklinik, we have published a user report in "QZ - Quality and Reliability". Read the full article here.
  • Smart sensor solutions need smart document control
    Together with our customer Sensirion AG, we have published a case study in the trade journal MQ Management und Qualität. Read the complete article here.
  • Mental health also needs processes
    Together with our customer Dr. Fontheim - Mental Health, we have published a case study in the trade journal QZ Qualität und Zuverlässigkeit. Read the full article here.

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