roXtra QM software in the GxP-regulated environment
Live your quality management in accordance with the requirements of the EU GMP and the GAMP 5 guidelines, ISO 13485 and other directives.
roXtra QM software in the GxP-regulated environment
Live your quality management in accordance with the requirements of the EU GMP and the GAMP 5 guidelines, ISO 13485 and other directives.
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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 need to be validated?
A number of different regulations, directives and guidelines as well as standards (e.g. AMWHV, MPV, ISO 13485 and EU GMP guidelines) require the validation of software.
This regulatory necessity is based on the fact that validation contributes significantly to the analysis and control of risks, the avoidance of potential hazards for patients / customers, personnel and third parties as well as to complete traceability.
Which software needs to be validated?
Companies often use a variety of different software systems: from email programs and operating systems to automation and control software. Validating all of these systems would be an enormous challenge and is disproportionate to the individual, respective risk.
The regulations therefore require that software systems that have a direct influence on manufacturing processes or service provision 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 provision (see example: roXtra). In addition, standards such as ISO 13485 go one step further and specifically require the documentation of the validation of computer software that is used 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 therefore depends on the one hand on which regulations you are subject to and on the other hand on the purpose for which you use the software.
Who carries out the software validation?
Regulations that require software validation are aimed at 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 does not exclude the possibility that you may be supported by the software manufacturer in validation activities. See the section "Can Roxtra GmbH support me with validation?".
What does software validation involve?
With the help of software validation, you want to ensure that the software meets your requirements and define measures 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 schedule 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 of the system are(user requirements). You then compare these specific user requirements with the functions of the software system(functional specifications).
The core of validation is risk analysis and assessment. This involves identifying and evaluating potential risks and taking measures to minimize them. In addition to testing the various functions of the software, user training, for example, is also a risk minimization measure.
Another important point is the definition of criteria and specifications for valid system operation. Here you define, for example, under which circumstances a revalidation of the system is necessary, at which intervals data backups (backup rules) take place and what is to be done in the event of a system failure (disaster recovery).
The final step of validation involves summarizing the results and releasing the system in the form of a validation report.
When must a software validation be carried out?
Software must be validated before it is used for the first time. This is required by DIN EN ISO 13485:2016-08 (chapter 4.1.6 ), among others.
In addition, the system must be validated again after changes (= revalidation). The regulations leave considerably more leeway with regard to revalidation. It is not clear which changes require a new, complete validation.
In addition to software updates, changes also include modifications to 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 procedure of revalidation should be defined as part of the initial validation. The decision for or against revalidation is usually made on the basis of a risk analysis. Changes to the software associated with the update to a more recent version can, for example, be viewed in the release notes and evaluated in advance.
Can Roxtra GmbH support me with the validation?
Validation always takes place in the application environment, but the user can still be supported by the manufacturer in some validation activities during software validation. For example, it makes sense for the manufacturer to make it clear which functions of the software are tested and in what way 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 in accordance with 21 CFR Part 11, which is the equivalent of a handwritten signature and can be clearly assigned to a person. In roXtra, the user name, 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.
The validation of roXtra provides GxP-compliant proof that its applicability in the specific application environment is ensured. Our software solutions are extensively tested in over 5,000 automatic and manual tests as part of quality assurance before delivery.
We are also happy to support and advise you on validating 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 validation report, is run through as an example. This simplifies and accelerates the development of your specific, documented procedure for the validation of computerized systems. roXtra has already been successfully validated by a large number of customers, from drug manufacturing institutes to medical device manufacturers.
Specific workflow with complete
audit trail.
Documents, such as Standard Operating Procedures (SOP), are regularly revised to accurately reflect current guidelines, requirements and procedures. With roXtra, you can automate the workflow from processing and checking through to approval with a subsequent training step.
This means that new revisions are only used once the employees have been instructed accordingly. Every step is documented by roXtra in the time-stamped audit trail, ensuring complete traceability.
Clear, up-to-date and traceable.
Thanks to roXtra, your documents are unique. This means that the title, type and description are clearly labeled and each document can be identified by a unique document number or ID. The documents are structured and easy to check, for example using the "Folder report" function.
An automatic validity check can also be stored in roXtra 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
User reports & blog posts
Would you like to find out more about roXtra GxP software in the life sciences, GMP and GxP environment? Do you have questions about international guidelines (e.g. the EC GMP guidelines, other EU directives or FDA regulations), the certification of manufacturers, the establishment of 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
Ulm University Hospital has become an integral part of the medical and scientific map of the region and the country. With 29 clinics and 15 institutes, it offers patients inpatient and outpatient medical care at the highest level. To ensure that the high ... Read more
Electronic records and signatures: Title 21 CFR Part 11
March 26, 2020
Digitalization, technological progress, globalization and increasing customer requirements present companies with major challenges. They have to achieve better results faster and faster with their financial and human resources. In order to sustainably improve competence, efficiency and customer orientation, ... Read more
January 22, 2020
"Who invented it?" an old advertising slogan that everyone probably knows. Behind it are the herbal sweets from the Swiss company Ricola AG. What consumers are often not aware of, however, is that the production of herbal products is subject to high quality standards and strict ... Read more
QM with roXtra software solutions in the "good working practice (GxP)" environment
Why roXtra GxP?
Companies in the medical, pharmaceutical and pharmaceutical chemistry sectors are required to use certified and validated systems in order to comply with strict regulations and ensure conformity. We supply you with roXtra as a GxP-compliant standard version and thus minimize the qualification and validation effort for your company.
The software solutions and the team at Roxtra GmbH support you in setting up, validating, maintaining, certifying and further developing your efficient QM system. roXtra GxP fulfills the requirements of current national and international regulations and guidelines that are placed on software in the area of quality and process management.
What is the purpose of the "Guidelines for Good Working Practice (GxP)"?
Extensive requirements are placed on software systems from the "good working practice (GxP)" environment. Patient safety is always the top priority. Regardless of whether you are working in the field 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 addition to 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). The GxP software is also used by companies that are subject to global standards such as those of the FDA, the EU GMP guidelines (in particular Annex 11 and Annex 15), the guidelines of the German Medical Association (Rili-BÄK), CE marking and the GAMP 5 guidelines. Read 🗎here how specific GxP requirements are implemented in roXtra.
The guidelines of
good working practice (GxP)
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