roXtra in a GxP-regulated environment

Operate your quality management according to the requirements of EU-GMP guidelines, DIN EN ISO 13485 and other regulations.

QM with roXtra in the environment of “good practice (GxP)”

The requirements for software systems in the field of “good practice (GxP)” are extensive. We supply roXtra as a GxP-compliant standard version and thus minimize your qualification and validation efforts.

roXtra GxP fulfils the requirements of current national and international regulations and guidelines, which are set for software supporting QM documentation.  These include, for example, the German Medicinal Products Act (Arzneimittelgesetz – AMG), the German Act on Medical Devices (Medizinproduktgesetz – MPG), the EU-GMP guidelines (especially Annex 11 and Annex 15), the Guidelines of the German Medical Association (Rili-BÄK), the Code of Federal Regulations (especially 21 CFR Part 11 and 21 CFR Part 820) and the GAMP 5 guidelines. 🗎Here you will find an overview of the implementation of GxP requirements in roXtra.

Electronic signature according to 21 CFR Part 11

roXtra supports an electronic signature according to 21 CFR Part 11, which is considered equivalent to a handwritten signature and can be clearly assigned to a person. In roXtra username, password and identification number (ID) are used as identification components. The meaning associated with the signature as well as the date and time are recorded in the audit trail.

   Equivalent to a handwritten signature
   Unique assignment
   Documented in the audit trail

Successful validation.

With the validation of roXtra, documented evidence is provided that the applicability in the specific user environment is ensured. Our software solutions are extensively tested in over 5000 automated and manual tests before they are delivered. In addition, we are happy to support and assist our customers during the validation of the system (e.g. according to GAMP 5) in your specific user environment. We provide sample documentation for this – from the validation plan (VP) all the way to the validation report.

Competent consulting services  
Test system setup  
Validation templates  
 

Individual workflow and end-to-end audit trail.

Documents such as Standard Operating Procedures (SOP) are regularly revised to reflect current policies, requirements and procedures. With roXtra you can automate the workflow from processing, through review and approval with subsequent training step. This means that new revisions are only used once employees have been appropriately trained. Each step is documented by roXtra in a time-stamped audit trail, thus ensuring complete traceability.

   GxP compliant workflows
   Time-stamped audit trail
   Complete revision histories

Conclusive, up-to-date and traceable.

Due to roXtra your documents are conclusive. This means that title, type and description are conclusively marked, and each document can be identified by a unique ID. The documents are structured and easy to control, for example using the “folder report” function. In roXtra an automatic validity check can also be activated so that your documentation is regularly checked and kept up to date. As soon as a document has been revised, the old revision is archived, thus preventing accidental use of the outdated version.

Unique document ID  
Automatic validity check  
Archiving obsolete revisions  
 

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