Regulatory compliance

For industries like life sciences, finance and manufacturing, compliance is not optional; it is the license to operate. Regulatory bodies (such as the FDA, EMA, SEC) mandate exactly what information must be provided to users, how it must be presented and how it must be translated.

Regulatory compliance in localization involves ensuring accuracy, traceability and clarity. A mistranslation in a Medical device technical file or a financial prospectus can lead to product recalls, fines or legal action. Therefore, compliant translation requires specialized workflows, including Back translation, validated audit trails and certification. RWS supports regulatory compliance through secure, ISO-certified processes and Structured content management. By managing regulated content in systems like Tridion Docs, organizations can guarantee that every version of a document is traceable, approved and compliant before it is published or submitted.