Validation
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Leipzig Validation
Leipzig Validation: How to Ensure Quality and Legal Certainty!
In Leipzig, one encounters the subject of validation in a wide range of areas. From the validation of student IDs to the validation of complex software systems, it is important to understand and correctly apply the processes. Would you like to learn more about how to optimize validation processes in your company? Get in touch with us here!
The topic briefly and concisely
Validation is versatile in Leipzig, from student ID validation at universities to preclinical validation of therapies at Fraunhofer IZI.
The ValiKom Transfer Project and the new validation procedure under § 1 paragraph 6 BBiG improve the recognition of professional skills, which enhances the employment prospects of skilled workers without formal qualifications.
The EMAS re-validation of the UFZ and the validation by the city of Leipzig staff demonstrate that validation also plays an important role in environmental management and in public administration, which can increase efficiency by up to 20%.
Discover the diverse applications of validation in Leipzig. Whether it's student identification, software, or professional skills, we'll show you how to successfully design validation processes and achieve legally sound results.
What Does Validation Mean?
Validation is a crucial process to ensure quality and legal certainty in various fields. At its core, it involves the confirmation and verification that a product, service, or system meets defined requirements and specifications. This can relate to documents, software, processes, or even professional competencies. Validation goes beyond mere verification; it ensures that the result is not only correct but also serves the intended purpose. At Mentoc, we provide professional translation services where validation plays a central role in ensuring your documents are accepted in an international context.
Definition and Delimitation
The definition of validation involves the systematic evaluation of whether a particular procedure or system delivers the expected results. This differs from verification, which focuses on whether a product has been created correctly according to specifications. Validation considers the entire lifecycle of a product or process, from conception through implementation to maintenance. The validation processes allow professional competencies to be identified, documented, evaluated, and certified.
Why Is Validation Important?
The significance of validation lies in ensuring quality and compliance. Through validation, standards and regulations are upheld, which is particularly critical in regulated industries such as pharmaceuticals, medical technology, or finance. Another key aspect is the minimisation of risks and prevention of errors that could lead to costly consequences. Validation helps to build trust in products and services and enhance customer satisfaction. At Mentoc, we place great importance on validating our translation processes to ensure your documents are not only linguistically accurate but also legally sound.
Overview of Validation Areas in Leipzig
In Leipzig, there is a variety of applications for validation, from universities to research institutions and businesses. For instance, HTWK Leipzig offers a validation station for HTWK-Cards, while Fraunhofer IZI focuses on the preclinical development and validation of novel therapies. Validation also plays a key role in environmental management, as illustrated by the EMAS re-validation of UFZ. This diversity highlights the broad applicability and relevance of validation in various sectors of the city. Validation is also of great importance in Berlin, particularly in the area of certified translations.
Easily validate student ID cards at HTWK and Uni Leipzig
HTWK Leipzig: Validation Station for HTWK Cards
The HTWK Leipzig has set up a self-service validation station for HTWK Cards (student ID cards) in the library. It is located on the ground floor staircase, right next to the charging station. This allows students to independently update their card validity after re-registration each semester. The validation station is accessible during the library's opening hours and offers a convenient alternative to manual validation. This implementation simplifies the administrative process and improves student access to validation services.
Self-Service Validation
The self-service validation offers a convenient update of student ID cards. Students can simply insert their HTWK Cards into the validation station and update their validity. The location of the validation station in the library is central and easily accessible. This saves time and effort, as students are no longer dependent on the opening hours of certain service facilities. HTWK Leipzig is thus opting for a modern and service-oriented solution.
Studentenwerk Leipzig: Courtesy Arrangement for Student ID Cards
The Studentenwerk Leipzig has introduced a courtesy arrangement for student ID cards due to COVID-19-related restrictions that made validation difficult. The MDV (Central German Transport Association) has implemented a special regulation for the summer semester 2021 MDV semester ticket, which corresponds to a similar special regulation from the summer semester 2020. If the student ID card only displays the winter semester 2020/21, students can present their enrolment certificate for the summer semester 2021 along with a photo ID. The enrolment certificate can also be presented on a mobile phone. This courtesy arrangement applies until all validation terminals are fully re-opened, plus an additional grace period of 14 days.
MDV Semester Ticket and COVID-19
The special regulations due to restrictions allowed students to use the MDV semester ticket despite lack of validation. The validity of the enrolment certificate in conjunction with a photo ID was recognized as a substitute for validation. This measure helped ensure the mobility of students during the pandemic. The Studentenwerk Leipzig responded flexibly to the special circumstances and offered a pragmatic solution.
Relevance for Students
Validation is of great importance for students as it enables access to services and offerings from universities and the Studentenwerk. Validation of the student ID is particularly required for the use of the semester ticket. Without a valid student ID, students may not be able to avail certain services. Therefore, it is important to regularly validate the student ID and to stay informed about current regulations and courtesy measures. At Mentoc, we support students with high-quality translations of their study documents to ensure international recognition of their achievements.
Fraunhofer IZI validates novel therapies for better medicine
Preclinical Development and Validation
The Fraunhofer IZI Department of Preclinical Development and Validation focuses on the preclinical validation of novel therapies. A key focus is the efficient development of in vitro and in vivo models for preclinical studies. The main objective is to pool expertise for the preclinical validation of new therapeutic approaches. The department develops and validates relevant models to test the efficacy and safety of drug candidates and medical devices.
Focus on Novel Therapies
The development of in vitro and in vivo models enables a comprehensive assessment of therapeutic approaches. Preclinical validation is a crucial step in recognising the potential of new therapies and minimising risks early on. In this way, the Fraunhofer IZI makes an important contribution to the development of innovative medical solutions. Validation includes the development of diagnostic methods for secretory and cellular protein biomarkers, including monoclonal antibody development and assay validation (e.g. ELISA, Luminex®, lateral-flow assay, flow cytometry).
GLP-Compliant Studies
An important aspect of the Fraunhofer IZI's work is conducting GLP-compliant and GLP-equivalent efficacy and safety studies for drug candidates (especially ATMPs) and medical devices (ISO 10993). This includes the development and validation of relevant models. GLP (Good Laboratory Practice) is a quality assurance system that ensures studies are conducted to the highest scientific standards. Compliance with GLP guidelines is particularly crucial for the approval of drugs and medical devices.
Efficacy and Safety Studies
Efficacy and safety studies assess the efficacy and safety of drug candidates and medical devices. The validation of study results is a decisive step in ensuring the quality and reliability of the data. The Fraunhofer IZI has extensive experience in conducting GLP-compliant studies, thus making a significant contribution to the development of safe and effective therapies.
Biomarker Development
Fraunhofer IZI identifies and validates protein biomarkers for diagnostics and therapy in chronic-inflammatory and tumour diseases as well as in regenerative medicine. Moreover, monoclonal antibodies against tumour targets (e.g. triple-negative breast cancer) are developed for drug development. Biomarker development is a significant area of research because it can help to detect diseases early and treat them more specifically. Fraunhofer IZI is also involved in the Fraunhofer Excellence Cluster for Immune-Mediated Diseases and conducts research specifically on therapies for chronic inflammatory bowel diseases.
Diagnostic Methods
The development of diagnostic methods includes the identification and validation of protein biomarkers. These biomarkers can help to detect diseases early and monitor therapy success. Fraunhofer IZI relies on modern technologies and innovative approaches. The validation of diagnostic methods is a critical step in ensuring the reliability and accuracy of results. At Mentoc, we support research institutions with legally compliant translations of study results and publications.
Have professional competencies recognised through the ValiKom Transfer procedure
ValiKom Transfer Project
The ValiKom Transfer Project, which ended on 31/10/2024, focused on the validation of professional competences acquired outside of formal education. The project aimed to facilitate the recognition of skills and knowledge that cannot be demonstrated through formal qualifications. This is particularly important for professionals without traditional qualifications, as it can enhance their employment prospects. The validation process allows for the documentation, assessment, and certification of professional skills, resulting in a certificate that verifies compliance with recognised professional qualifications.
Recognition of Non-Formally Acquired Competences
The goal of the project was to highlight professional competences not achieved through formal educational qualifications. The project workflow included assessment and certification by chambers, leading to a certificate that details the demonstrable skills. The procedure targeted individuals with relevant expertise but without formal qualifications. By the end of the project, it was offered by 32 chambers across Germany.
New Validation Procedure under § 1 Paragraph 6 BBiG
Since 01/01/2025, there is a new, legally regulated validation procedure (in accordance with § 1 paragraph 6 BBiG), available through chambers of crafts, industry and commerce chambers, or agricultural chambers. This procedure builds on the experiences from the ValiKom Transfer Project and aims to further enhance the recognition of non-formally acquired competences. The legal basis and implementation of the procedure are established in § 1 paragraph 6 of the Vocational Training Act (BBiG). The procedure targets individuals who possess professional competences but do not have a formal vocational qualification.
Legal Basis and Implementation
The responsibility for conducting the validation procedure lies with the chambers (chambers of crafts, IHK, agricultural chambers). These chambers have the necessary expertise and infrastructure to assess and certify the applicants' competences. The procedure usually includes an individual competence assessment, where the applicant’s skills and knowledge are evaluated through practical tasks and expert discussions. Upon successful validation, participants receive a certificate that attests to their competences.
Validation Service Centre
A new Validation Service Centre, supported by the Federal Ministry of Education and Research, has been assisting the chambers with the implementation of this new procedure since 01/11/2024. The Validation Service Centre's role is to support the chambers in the implementation of the validation procedure and to ensure the quality of the validation. It offers the chambers training, consultations, and informational materials. Additionally, the Validation Service Centre develops quality standards and tools for validation.
Support for the Chambers
The duties of the Validation Service Centre include the advising and supporting the chambers in the implementation of the validation procedure. The service centre's goals are to promote the validation of professional competences and improve recognition of professionals without formal vocational qualifications. The service centre ensures that the validation procedure is carried out uniformly and with quality assurance nationwide. At Mentoc, we offer professional translations for certificates and other documents required in the validation process.
UFZ focuses on sustainable environmental management through EMAS validation
EMAS Re-Validation of the UFZ
The UFZ (Helmholtz Centre for Environmental Research) successfully completed its 20th EMAS re-validation in June 2024. This underscores UFZ's ongoing commitment to sustainable environmental management. EMAS (Eco-Management and Audit Scheme) is a voluntary environmental management system by the European Union that assists companies and organisations in continuously improving their environmental performance. The EMAS validation confirms that UFZ's environmental management system complies with the requirements of the EMAS regulation.
Sustainable Environmental Management
The successful re-validation in June 2024 demonstrates that UFZ has implemented an effective environmental management system. UFZ is committed to continuously improving its environmental performance and minimising its environmental impact. UFZ's environmental management system encompasses all areas of the organisation, from research to administration to the operation of buildings and facilities. UFZ relies on innovative technologies and measures to achieve its environmental goals.
UFZ's Strengths in the Environmental Sector
Among the strengths of the UFZ in the environmental sector are the effective transfer of research results to society and politics and the pronounced awareness of the associated environmental impacts. Internal communication, employee engagement, and management's commitment to environmental goals were also praised. UFZ aims to make its research results available for solving environmental problems. UFZ works closely with politics, business, and civil society to put its research results into practice.
Transfer of Research Results
The transfer of research results is an important contribution of UFZ to solving environmental problems. Internal communication and employee engagement ensure that all UFZ employees are committed to environmental protection. Management's commitment to environmental goals is a decisive success factor for UFZ's environmental management. UFZ relies on open and transparent communication to inform stakeholders about its environmental performance.
Awards and Recognition
In 2023, UFZ was honoured with the award for "Best EMAS Environmental Statement" and received silver status as a "Bicycle-Friendly Employer" in 2022 and 2023. Furthermore, UFZ is recognised by the Environment Alliance Saxony for the years 2022-2025. These awards and recognitions demonstrate that UFZ is a pioneer in sustainable environmental management. UFZ is committed to environmental protection and contributes to improving the quality of life in Saxony and Germany.
Best EMAS Environmental Statement and Bicycle-Friendly Employer
The award of "Best EMAS Environmental Statement" acknowledges UFZ's transparent and comprehensive reporting on its environmental performance. The silver status as a "Bicycle-Friendly Employer" shows that UFZ is committed to the promotion of cycling. Recognition by the Environment Alliance Saxony confirms UFZ's dedication to environmental protection. We at Mentoc support companies and organisations with professional translations of environmental statements and other documents in the field of environmental management.
Administrator Validation at the City of Leipzig: Tasks and Requirements
Scope of Responsibilities
The role of Validation Officer at the City of Leipzig involves validating digital invoice entries via WMD xSuite for SAP. The focus is on plausibility checks and ensuring correct allocation to relevant departments. A key aspect is the meticulous processing of business partner data within SAP, including duplicate checks using online resources, and in exceptional cases, even the register of residents. The role requires collaboration with various departments to resolve invoice-related issues and optimize the zRE process. The job posting on LinkedIn provides further details on the tasks.
Validation of Digital Invoices
The validation of digital invoices includes the assessment of the plausibility and accuracy of data. Correct allocation to the relevant departments is crucial for a smooth invoice process. Collaboration with various departments enables the resolution of discrepancies and process optimization. The City of Leipzig leverages modern technologies to make the invoice process more efficient and transparent.
SAP and Business Partner Data
Meticulous data maintenance in SAP is an important part of the responsibilities of the Validation Officer. Duplicate checks using online resources, and in exceptional cases, even the register of residents ensure that the data is accurate and current. Collaboration with various departments facilitates the resolution of discrepancies and optimization of the data inventory. The City of Leipzig places great importance on the quality of its data and relies on modern technologies to ensure it.
Meticulous Data Maintenance
Meticulous data maintenance involves the assessment of the completeness, accuracy, and timeliness of data. Duplicate checks serve to identify and clean up incorrect or duplicate data sets. Collaboration with various departments enables the resolution of discrepancies and optimization of the data inventory. The City of Leipzig uses modern technologies to make data maintenance more efficient and effective.
Cash and Budgetary Law
For the role of Validation Officer, knowledge of cash and budgetary law is required. The position is temporary and subject to specific legal conditions. The position is temporary and subject to restrictions due to previous employment with the City of Leipzig. The City of Leipzig places great emphasis on adherence to legal conditions and relies on qualified employees who possess the necessary knowledge.
Knowledge Required
Knowledge of cash and budgetary law is essential for the correct processing of invoices and compliance with legal regulations. The temporary nature of the position and the legal conditions are important aspects to consider when applying. The City of Leipzig offers its employees an attractive working environment and diverse development opportunities. At Mentoc, we offer professional translations for application documents and other materials in the field of public administration.
Validation experts in Leipzig: Salary potential and influencing factors
Average Salary
In Leipzig, validation experts earn an average of €40,973 per year, with the salary range between €37,246 and €52,341. Specialisations in areas such as method validation, software validation, or system validation can lead to higher salaries (approximately €57,000 to €61,000). Career development and increasing responsibility, especially positions with managerial duties, have a significant impact on earning potential. Larger companies tend to pay higher salaries than smaller ones.
Salary Range and Influencing Factors
The salary range for validation experts in Leipzig is dependent on various factors, such as specialisation, professional experience, and managerial responsibilities. The size of the company also plays a role. Method validation, software validation, or system validation can lead to higher salaries. Continuous professional development is crucial to enhance salary potential.
Salary Differences
Larger companies tend to pay higher salaries than smaller ones. Career development and increasing responsibility, particularly positions with managerial duties, have a significant impact on earning potential. Relevant experience and continuous professional development are key to salary growth. The salary data from Jobvector provides a detailed overview of salary prospects for validation experts in Leipzig.
Company Size and Career Development
Company size and career development are important factors influencing the salary of validation experts. Willingness to engage in further education also plays a role. Continuous professional development is important to boost salary potential. Validation experts with managerial duties generally earn more than those without such responsibilities.
Validation in Leipzig: Your Key to Quality and Efficiency
Overview of the Different Areas of Validation
Validation plays a significant role in various areas in Leipzig, ranging from educational institutions and research facilities to companies. The HTWK Leipzig offers a validation station for HTWK-Cards, Fraunhofer IZI focuses on preclinical development and validation of novel therapies, and UFZ is committed to sustainable environmental management through EMAS validation. The city of Leipzig also requires skilled personnel in the field of validation, as shown by the job advertisement for a validation clerk. This diversity highlights the broad applicability and importance of validation across different sectors in the city.
Diversity and Importance
The diversity of validation areas in Leipzig shows that validation is a crucial part of quality assurance and efficiency enhancement. The significance of validation is underscored by its various application fields in educational institutions, research facilities, and companies. Validation ensures that products, services, and processes meet defined requirements and specifications.
Outlook on Future Developments
Validation will continue to play a key role in the future, especially concerning the digitalization and automation of processes. The increasing importance of sustainability and environmental protection will also raise the requirements for validation. Validation experts will therefore remain in demand in the future. At Mentoc, we support companies and organizations with professional translation services to optimize their validation processes and support their international business activities.
Trends and Innovations
Trends and innovations in the field of validation include the automation of validation processes, the use of artificial intelligence, and the development of new validation methods. The growing importance of data integrity and security will also increase the demands on validation. Validation will remain an essential component of quality assurance and efficiency improvement in the future.
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More useful links
The HTWK Leipzig offers a validation station for HTWK cards (student ID cards) to allow for self-service updates on the validity of the cards following each semester's re-registration.
The Fraunhofer IZI focuses on the preclinical development and validation of novel therapies, with an emphasis on the efficient creation of in vitro and in vivo models for preclinical studies.
The UFZ (Helmholtz Centre for Environmental Research) has successfully undergone its EMAS re-validation, highlighting the ongoing commitment to sustainable environmental management.
The Studentenwerk Leipzig has introduced a goodwill policy for student ID cards, enabling students to use the MDV semester ticket despite COVID-19 related restrictions.
The ValiKom Transfer Project focused on the validation of professional skills acquired outside formal education, to enable the recognition of skills and knowledge.
FAQ
What does validation mean in the context of Leipzig?
Validation is the confirmation and verification that a product, service, or system meets defined requirements and specifications. In Leipzig, validation occurs in various sectors such as universities, research institutions, and businesses.
Where can students in Leipzig validate their student IDs?
The HTWK Leipzig provides a self-service validation station for HTWK cards in the library. The Studentenwerk Leipzig has introduced discretionary policies for student IDs to facilitate the use of the semester ticket despite restrictions.
What role does validation play in research in Leipzig?
The Fraunhofer IZI focuses on the preclinical development and validation of novel therapies to test the efficacy and safety of drug candidates and medical devices.
What is the ValiKom Transfer Project and how is it related to validation?
The ValiKom Transfer Project focused on the validation of professional competencies acquired outside formal education. Since 2025, there is a new, legally regulated validation procedure.
How does the EMAS Re-Validation of UFZ contribute to environmental protection?
The EMAS Re-Validation of UFZ underscores the ongoing commitment to sustainable environmental management and confirms that the environmental management system complies with the requirements of the EMAS regulation.
What are the responsibilities of a validation specialist at the City of Leipzig?
A validation specialist at the City of Leipzig validates digital invoice entries via WMD xSuite for SAP and ensures correct allocation to the relevant departments.
What is the average salary for validation experts in Leipzig?
In Leipzig, validation experts earn an average of €40,973 per year, with specialisations and managerial responsibilities potentially leading to higher salaries.
How can government grants aid in validation?
Government grants provide the opportunity to invest in high-quality validation processes, enhancing efficiency and ensuring compliance with standards.
