How to Ensure Translation Accuracy in Regulated Industries

When you work in a regulated industries like healthcare, finance, pharmaceuticals, energy, or legal services, accuracy in documentation goes beyond important to non-negotiable.

If you have a mistranslation this can have serious consequences such as compliance failures, financial penalties, reputational damage, or even safety risks.

As a Language Service Provider (LSP), we know that our clients in regulated sectors need much more support than just fluency in a language. They need a precise, methodical approach.

In this article, we’ll look at the most important things to consider and implement to make sure your documents meet the highest standards of accuracy and compliance.

Work with Subject-Matter Expert Translators

Your translator in a regulated industry must understand more than just the language, they must understand the regulations, terminology, and nuances of your field.

• Industry-specific knowledge — A translator with a background in pharmaceuticals, for example, will be familiar with clinical trial protocols, medical terminology, and the style required for regulatory submissions.
• Ongoing professional development — Regulations change. Translators who continually update their knowledge can help you stay compliant.
• Experience with similar documents — A translator who has worked on similar projects to yours will know the pitfalls to avoid.

The bottom line is we’d never recommend using a generalist translator to handle regulated documents just because they’re fluent in both languages. Always verify their expertise in your specific industry.

Establish a Glossary and Style Guide Beforehand

Consistency is crucial in regulated content. In these industries, one mistranslated term can cause confusion or non-compliance.

• Glossary — Compile a list of approved industry terms, product names, and abbreviations in both the source and target languages.
• Style guide — Define your formatting rules, tone, measurement units, and date formats to ensure uniformity across all documents.

If you think this doesn’t matter, it does. Regulators expect precise and consistent terminology from you. Inconsistent wording can signal inaccuracy or lack of quality control.

Use Translation Memory (TM) for Consistency

Your TM stores previously translated segments for reuse in future documents.

• Advantages — They save time, reduce errors, and ensure consistency across large volumes of content.
• Compliance benefit — If a particular regulatory phrase has been approved before, TM ensures it is reproduced with 100 percent accuracy.

It’s important to note, however, that translation memory is not a substitute for human review. The best way to look at it is as a support tool to maintain consistency.

Implement a Multi-Step Quality Assurance Process

In regulated industries, a single review is rarely enough. Consider a layered approach which includes the following steps:

1. Initial translation by a subject-matter expert.
2. Bilingual editing to refine terminology, tone, and accuracy.
3. Independent proofreading by another linguist.
4. Final in-context review to ensure formatting, layout, and compliance requirements are met.

What you’re doing is manufacturing quality checks, where each step reduces the risk of an inaccurate translation.

Involve Legal and Regulatory Review

Even if your translator is an expert, compliance specialists should review translated documents before submission.

• Regulatory compliance check — Ensure the translation adheres to specific requirements from industry bodies or local regulators.
• Legal verification — Contracts, disclaimers, and compliance statements should be reviewed by bilingual legal professionals to avoid loopholes or misinterpretations.

Maintain Secure Handling of Documents

Regulated industries often deal with confidential or sensitive information. Data breaches can be just as damaging as translation errors.

• Secure file transfer — Use encrypted platforms for sending and receiving files.
• Non-Disclosure Agreements (NDAs) — Ensure all your linguists and vendors sign binding confidentiality agreements.
• Controlled access — Limit document access to authorized team members only.

Plan for Localization, Not Just Translation

In some regulated industries, simply translating the words isn’t enough. You must adapt the content for local laws, standards, and cultural practices.

For example:

• A pharmaceutical label for the EU may require different dosage instructions than the US version.
• Financial disclosures in one country may require additional disclaimers in another.

Localization ensures your document isn’t just linguistically correct, but also legally and culturally compliant in the target market.

Audit and Update Regularly

Regulations evolve, and as they do so should your translated materials.

• Periodic audits — Review past translations to ensure they still meet current legal requirements.
• Version control — Keep track of updates so your outdated translations aren’t mistakenly reused.
• Ongoing feedback — Encourage translators and reviewers to flag changes in terminology or law as they arise.

Train Your Internal Team

Even with the best translators, your internal staff plays a role in accuracy. They’re the ones in the business, day in day out, who know how you operate.

• Clear source documents — Errors in the source text will be faithfully reproduced in the translation.
• Defined processes — Everyone should know how to request, review, and approve translations.
• Terminology awareness — Teams should understand why certain terms are used consistently.

Regulate Your Process

Getting your own process right, and sticking to it, comes down to blending linguistic precision, industry expertise, rigorous reviews, and strict adherence to compliance standards.

By working with subject-matter experts, creating clear terminology resources, leveraging technology, and having multi-layered quality checks, you not only protect your organization from costly errors, but you also strengthen your reputation for reliability and professionalism.

Do you work in a regulated industry and need translation support? If so, we’d love to talk to you. Consultations are free and there’s no obligation.

You’re in safe hands with us as we’re ISO 17100 and ISO 9001 compliant, have over twenty years of professional translation experience, and have earned the trust of organizations around the world.