ISO 17100-compliant translations. Human expertise.

Audit Ready • Regulatory Affairs and Quality

Audit Ready is not a software. It is a dedicated, human-led translation process built for companies where compliance is non-negotiable. Every step is auditable, traceable, and defensible.

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30-minute compliance check-up, no strings attached

Certified by Austrian Standards

ISO 17100

Translation quality standard

ISO 18587

AI translation post-editing standard

Trusted by

The compliance challenge

Generative AI translation tools are flooding the market, creating new compliance and audit challenges. As regulatory expectations continue to evolve, organizations need translation processes that provide documented human oversight, full traceability, and a defensible audit trail.

Why it matters

Regulators are increasingly scrutinizing the use of AI in regulated content processes. Demonstrable human oversight is becoming essential.

Notified Bodies frequently identify insufficient segregation of roles and incomplete traceability as audit findings.

For high-risk content, independent verification methods such as back translation can provide additional evidence of translation accuracy and support audit readiness.

The rise of AI is reshaping expectations. Procurement teams and regulators increasingly expect translation processes that provide human oversight, documented quality, and full traceability.

What Audit Ready means for you compliance

Separate Translator and Reviser Roles

A documented, ISO 17100-compliant two-step process with clearly defined roles for translation and independent revision. Every project follows strict segregation of responsibilities.

Documented Linguist Qualifications

Translator qualifications, native-language competence, and industry expertise documented for every project. Fully aligned with ISO 17100 requirements.

Enhanced Quality Control for High-Risk Content

For high-risk content, including clinical trial documents, package inserts, informed consent forms, and patient labeling, an independent linguist performs back translation into the source language. Any discrepancies are reviewed, reconciled, and documented to maintain traceability.

Complete Version History and Traceability

Reconstruct the complete history of every translated segment: who translated, who revised, who approved, when actions occurred, and what decisions were made. Full traceability to support confident responses during regulatory reviews.

Human Control at Every Step

No AI-generated translations enter your translation memory. Any AI-assisted content, when appropriate, is strictly controlled, segregated, and documented separately from human-generated translations.

On-Demand Compliance Reporting

Structured reporting designed to support efficient responses to audits and inspections.

A Proven Process, Not Software

Nothing to install. No new platform to validate. Audit Ready integrates seamlessly into your existing regulatory workflows

Full Traceability. Faster Audit Readiness.

Every linguist action, revision, and timestamp is captured and retained, creating a complete audit trail.

What about AI? Acceptable when controlled, documented, and human-oversighted.

Neither the MDR nor FDA requirements prohibit machine translation. The key requirement is demonstrable human oversight and control. ISO 18587 defines the framework for human post-editing of machine translation output by qualified experts. Every translation processed through this workflow is traceable, documented, and quality-controlled. Harness the efficiency of AI while maintaining compliance-focused oversight.

Compliance-ready across markets

United States

• FDA submissions (multilingual package inserts and labeling)
• 21 CFR Part 11 requirements
• Clinical trial documentation

France and EU

• MDR / IVDR translation requirements
• EMA & ANSM submissions
• Tool documentation

Canada

• Health Canada bilingual requirements
• French-language compliance (Quebec Bill 14)
• Official Languages Act obligations

South Korea

• KFDA / MFDS submissions
• Korean Medical Devices Act (KMDA)
• Clinical trial documents and package inserts in Korean

Discovery session

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