roXtra
The software for your digital quality managementVersion: 9
Version: 9
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!
AUDITMANAGEMENT
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.
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 www.roxtra.com.