QM Software 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 Software 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.
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Software validation
What is validation?
Validation describes the documented proof that the applicability in the specific application environment is ensured. The term validation is often used as an umbrella term for the validation of manufacturing processes, cleaning processes, analytical methods, technical equipment or even software systems.
Why does software have to be validated?
A number of different regulations, guidelines and standards (e.g. AMWHV, MPV, ISO 13485 and EU GMP guidelines) require the validation of software.
This regulatory requirement is based on the fact that validation contributes significantly to the analysis and control of risks, the avoidance of potential hazards for patients / customers, staff and third parties as well as to complete traceability.
Which software needs to be validated?
Companies often use a multitude of different software systems: from email programmes and operating systems to automation and control software. Validating all these systems would be a huge challenge, and it is not relative to the individual, specific risk.
The regulations therefore require that only software systems that have a direct influence on manufacturing processes or service performance must be validated.
Does roXtra need to be validated?
Yes. The current GxP regulations require the validation of software that has a direct influence on manufacturing processes or service performance (see example: roXtra). In addition, standards such as ISO 13485 extend this one step further and specifically require the documentation of the validation of computer software that finds application in the quality management system (DIN EN ISO 13485:2016-08 chapter 4.1.6).
Whether the validation of roXtra is necessary in your company depends on the regulations that you are subjected to and the purpose that you use the software for.
Who is responsible for the software validation?
Regulations requiring software validation are addressed to the users of the respective software. They are obliged to ensure the suitability of the respective system for its intended use. Accordingly, validation is also the responsibility of the user.
However, this fact does not exclude that you can be supported by the software producer in validation activities. See the section "Is it possible for Roxtra GmbH to support me during the validation process?“.
What does a software validation involve?
Software validation is a way to ensure that the software fulfills your requirements and to define actions to minimize the associated risks.
The first step is to plan your validation activities (validation plan). The validation plan (VP) includes, for example, the purpose of the validation, a description of the system and the system environment as well as the time frame and definition of roles and responsibilities.
In order to check whether a software fulfills your specific requirements, the next step is to clearly show what your requirements are (user requirements). Then, you compare these specific user requirements with the functions of the software system (functional specifications).
The core of validation is risk analysis and assessment. The aim is to identify potential risks, evaluate them and take actions to minimise them. In addition to testing the various functions of the software, user training, is also an action to minimise risks.
Another important point is the definition of criteria and specifications for valid system operation. Here you specify the circumstances that require a revalidation of the system, the time intervals for data backups (backup rules) and what to do in the event of a system failure (disaster recovery).
The final step of the validation involves summarising the results and releasing the system within the validation report.
When should the software validation be completed?
Software must be validated before it is used for the first time. This is required, for example, by DIN EN ISO 13485:2016-08 (Chapter 4.1.6 ).
In addition, the system must be revalidated after changes (= revalidation). With regard to revalidation, the regulations are less specific. It is not clear which changes require a new, complete validation.
In addition to software updates, changes also include modification of the software's area of application. It may therefore be necessary to revalidate the system if its use is extended to other areas of the company, for example.
The criteria for the necessity and the procedure of revalidation should be determined within the framework of the initial validation. The decision for or against revalidation is usually made on the basis of a risk analysis. New features of the software that are associated with the update to a more recent version can be viewed in the release notes and evaluated in advance.
Is it possible for Roxtra GmbH to support me during the validation process?
Validation always takes place in the application environment, but the manufacturer can still support the user in some validation activities. For example, it makes sense for the manufacturer to make clear which functions of the software are already tested before delivery. The user of the software takes this into account within the risk assessment and aligns his own test and qualification cases accordingly.
Proven functions for use in the GxP-regulated environment
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.
Successful validation.
With the validation of roXtra, the GxP-compliant proof is provided that the applicability in the specific application environment is ensured. Our software solutions are extensively tested in over 5000 automatic and manual tests as part of quality assurance even before the system is delivered.
In addition, we are happy to support and consult you in the validation of the system in your specific application environment. For this purpose, we can offer you sample documentation in which the validation, from the validation plan (VP) to the report, is run through as an example. This simplifies and accelerates the development of your specific, documented procedure for the validation of computer-aided systems. roXtra has already been successfully validated at a large number of customers, from pharmaceuticals manufacturing institutes to medical device manufacturers.
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.
Thus, new revisions are only used once employees have been appropriately trained. Each step is documented by roXtra in the time-stamped audit trail, so that complete traceability is ensured.
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. The GxP software offers a high level of security for your data. Access to the system is protected by entering a user ID and password, among other things.
More information on Document Workflow with roXtra
Case Studies & Blog Posts
You would like to learn more about the GxP software roXtra in the life sciences, GMP and GxP environment? Do you have questions about international guidelines (e.g. the EC GMP guidelines, other EU guidelines or FDA regulations), the certification of manufacturers, the establishment of a compliance-compliant quality management, the IT infrastructure of your organization or the validation of computer-aided systems? In our blog we regularly inform you about exciting projects and topics in this area.
Successful validation results speak for themselves: roXtra at Ulm University Hospital
November 10, 2020
It is impossible to imagine the medical and scientific map of the region and the country without the University Hospital Ulm. With 29 clinics and 15 institutes, it offers patients inpatient and outpatient care at the highest level. To ensure that the high ... Read more
Electronic Records and Signatures: Title 21 CFR Part 11
26 March 2020
Digitization, technological progress, globalization and increasing customer requirements present companies with major challenges. You have to achieve better and better results with your financial and human resources faster and faster. In order to sustainably improve competence, efficiency and customer orientation, ... Read more
22 January 2020
"Who invented it?" is a former advertising slogan that everyone probably knows. Behind it are the herbal sweets from the Swiss company Ricola AG. What consumers are often unfamiliar with, however, is that the production of the herbal products is subject to high quality standards and strict ... Read more
QM with roXtra in the environment
of "good practice (GxP)".
Why roXtra GxP?
Companies in the fields of medicine, pharmacy and pharmaceutical chemistry are required to use certified and validated systems in order to meet the strict regulations and to ensure conformity. We therefore provide you roXtra as a GxP-compliant standard version and thus minimise the qualification and validation effort for your company.
The software solutions and the team of Roxtra GmbH supports you in setting up, validating, maintaining, certifying and further developing your efficient QM system. roXtra GxP meets the requirements of current national and international regulations and guidelines for software in the field of Quality and Process Management.
What is the purpose of the "Guidelines of Good Practice (GxP)"?
Extensive requirements are placed on software systems from the environment of "good practice (GxP)". The topic of patient safety is always at the top of the list. Regardless of whether you are working in the area of Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP) or Good Distribution Practice of medicinal products for human use (GDP), all influences on your product must be continuously monitored.
In accordance with laws such as the German Medicines Act (AMG), the German Medical Devices Act (MPG) and the Code of Federal Regulations (in particular 21 CFR Part 11 and 21 CFR Part 820), our software products meet the requirements of standards such as ISO 9001 and DIN EN ISO 13485 (medical devices - quality management systems). Additionally, GxP software is used by companies which are subject to global standards such as those of the FDA, the EU GMP Guide (in particular Annex 11 and Annex 15), the guidelines of the German Medical Association (Rili-BÄK), CE marking and the GAMP 5 Guide. Read 🗎here how concrete GxP requirements are realized in roXtra.
The guidelines of the
good practice (GxP)
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