We follow all applicable and relevant industry standards and fulfill all guidelines of DIN EN ISO 17100. In addition, we are certified according to DIN EN ISO 9001.
In order to exceed the quality standards of the pharmaceutical industry, we work in a strongly process-oriented manner. We established our own processes and tools according to the different types of documents and different customer requirements. In addition, we see ourselves as your partner and not just as a translation service provider, which means that we work with you to design systems and processes in such a way that you can expect long-term benefits such as cost reductions and shortened turnaround times, while we guarantee the same quality standards.
We not only provide precise workflow management by trained and experienced project managers with scientific and/or linguistic backgrounds but also quality checks in several steps, always adapted to the type of document and its intended use.
Our tools also vary depending on the process and systematically support the workflow:
- From standard quality assurance (QA) to consistency and terminology tools within the pharmaceutical and medical industry.
- Software tools for customer-specific or differentiated QAs
- Internal QA tools based on regulatory requirements
- Process and quality support tools such as translation memory systems and terminology databases
- Feedback loop tools
Revision of the Initial Translation According to DIN EN ISO 17100
An essential part of quality assurance (according to DIN EN ISO 17100) is the revision of the initial translation by a second independent language expert. This includes:
- Sentence-by-sentence linguistic review of the translation against the source text
- Target group and target market-relevant review/adjustment
- Interpretation, spelling and grammar
- Consideration of glossaries, terminology and consistency
Technical Review of the DIN 17100 Translation
Monolingual technical review of the translation by an independent third party expert (medical specialist, pharmacist, chemist, biochemist and life science specialist):
- Professional understanding
- Misinterpretation and
- Specialized terminology
Quality Assurance Checks in a Multi-Stage System
Sustainable and long-term quality assurance is ensured by a multi-stage evaluation process during and after each project. Depending on the type of project and document, electronic quality tools and/or expert-based quality checks are used to identify and correct any discrepancies in the translation. Tools make the translation process more controllable, transparent and efficient – in other words, faster, cost-effective and of higher quality.
We offer and incorporate a comprehensive range of different testing and quality assurance steps, as translation quality testing is carried out in many different ways throughout the translation and correction process. The bilingual or multilingual glossary of a translation project is checked and validated by a technical and/or linguistic expert, taking into account the source text. If desired, the terminology adjustments can be integrated directly into existing translations to ensure terminological consistency.
Standardized methods for measuring translation quality and quality indicators are used as a basis for categorization.
A Professional Team – Project Managers, Translators, Language and Professional Experts
Our project management team consists of professionally and methodically trained project managers who are compliant with the processes and standards in the healthcare industry. Our team can manage small, medium and large volumes in all languages.
The project management team is interdisciplinary and consists of:
- Certified translators
- Business economists
- IT specialists.
Furthermore, only selected and certified experts who meet at least the following requirements are entrusted to perform the translations:
- Native speakers of the target language
- Medical and technical translators
- Medical and scientific experts (medical specialist, pharmacist, chemist, biochemist, life science specialist, etc.) with appropriate degrees and in-depth linguistic expertise
- Many years of experience in the translation and linguistic field
- IT specialists.
Please feel free to request CVs before the start of the project. At the start of the collaboration, we build up a pool of translators or experts specifically for each client to ensure consistent quality. These translators are trained specifically for your requirements.
KPIs in the Translation Process
Our goal is to constantly improve our performance and to continuously improve our processes. Measuring our performance is the basis for this.
The quantitative collection of “Key Performance Indicators” (KPIs) is part of every project. Time, costs or cost savings and the quality of the individual delivery are the main indicators for assessing our performance.
Data security in the Translation Process
Special security and confidentiality standards are absolutely necessary for the healthcare industry and are therefore inevitable for us. We are used to working with sensitive data and managing it securely.
Data security has two aspects:
Protection of data against unauthorized access and protection against data loss. Both aspects are guaranteed for your data. Continuously updated and repeatedly tested data security and disaster recovery/business continuity plans document our protective measures for your data.
Redundant systems backed up cross-site, strict separation of client data or encrypted email communication are our standards.
Please feel free to communicate with us. We are happy to adjust our services to your requirements.