Meet Sesen at DIA 2025 in Washington, D.C.
Join us June 15–19 at Booth #2013 to explore global clinical and regulatory language solutions.

No, thanks

BOOK A MEETING BOOK A MEETING
Sign In
quality-assurance-audit-translation

Why QA Audit Translation Matters in Life Sciences

Accurate and consistent translation of quality assurance (QA) documentation is critical for maintaining regulatory compliance across global life sciences operations. Pharmaceutical, biotechnology, and medical device companies must prepare for audits conducted by international regulatory bodies such as the FDA, EMA, PMDA, and ISO-certifying agencies. These inspections often require the submission of multilingual documentation, including GMP protocols, quality manuals, and audit findings.

Translation errors or inconsistencies can lead to audit delays, regulatory citations, or rejected submissions. In highly regulated environments, even minor linguistic discrepancies can compromise data integrity or misrepresent quality processes. That is why precise language, controlled terminology, and adherence to validated translation workflows are essential.

High-quality QA translations also support traceability throughout the document lifecycle. From SOP revisions to CAPA reports, translated materials must retain their original intent, technical meaning, and regulatory alignment to withstand inspection scrutiny. With the growing globalization of manufacturing and supply chains, multilingual QA documentation is not optional, it is a regulatory necessity.

Sesen specializes in translating quality assurance audit documentation with a focus on accuracy, consistency, and audit readiness. Our ISO-certified processes and scientific subject matter expertise help clients reduce compliance risks and demonstrate robust quality control across borders.

Read More Read Less

What We Translate for Quality Assurance Audits

Sesen delivers high-accuracy translations for a full range of quality assurance documentation required during regulatory inspections and internal audits. Our work supports life sciences companies preparing for FDA, EMA, PMDA, and ISO audits across multilingual markets. Each document is translated with strict adherence to industry-specific terminology, regulatory context, and format consistency.

We provide certified translations for the following QA audit-related materials:

Our operations are fully certified to ISO 17100 (translation services), ISO 9001:2015 (quality management), and ISO 13485:2016 (medical devices), ensuring repeatable, auditable quality across all regulatory deliverables.

We provide structured, version-controlled deliverables with complete revision histories—ready for submission or regulatory audit at any time.

All translations are performed by qualified, professional native linguists with subject-matter expertise in regulatory, clinical, and technical content.

We use secure, validated systems that support electronic records and signatures, with full traceability for submissions to the FDA and other digital-authority frameworks.

Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.

Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.

Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.

Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.

Every translation is managed with robust version control, enabling transparent collaboration and clear documentation of updates, comments, and reviewer changes.

Sesen ensures all translated materials meet the linguistic, technical, and regulatory expectations of global quality systems, helping life sciences clients maintain full inspection readiness across all operational regions. Explore our full range of GMP and Manufacturing Translation Services.

Certified Translation Workflows and Standards

Sesen’s quality assurance audit translation services are built on certified workflows that align with the most recognized international standards in both translation and life sciences compliance. These certifications validate our commitment to delivering linguistically accurate, technically precise, and audit-ready translations.

We operate in full compliance with the following standards:

  • ISO 17100 – International standard for translation services, specifying requirements for translator qualifications, project management, and quality assurance across all language projects.
  • ISO 9001:2015 – Quality management system certification that governs our internal processes, continuous improvement practices, and client satisfaction protocols.
  • ISO 13485:2016 – Standard for medical device quality management systems, specifically addressing documentation and process control for life sciences and regulated industries.

These standards form the foundation of every project we manage. From translator selection and terminology management to final quality control checks, each stage of the workflow is governed by traceable procedures designed to ensure consistency, compliance, and regulatory alignment. Our clients benefit from a documented audit trail for every translation delivered, helping them meet global inspection and documentation requirements with confidence.

Read More Read Less

Subject Matter Expertise in Quality and Manufacturing

Sesen assigns professional native linguists with specialized backgrounds in quality assurance, quality control, regulatory affairs, and pharmaceutical manufacturing. Our translators are not only fluent in the target language but also trained in the technical nuances of life sciences documentation, ensuring accurate interpretation of industry-specific terminology and regulatory context.

We support translation for highly specialized content, including:

  • Biologics and Active Pharmaceutical Ingredients (APIs)
    Expertise in translating manufacturing protocols, batch records, and validation data for complex drug substances.
  • Sterile Processing and Aseptic Techniques
    Familiarity with terminology related to cleanroom procedures, contamination control, and environmental monitoring.
  • Validation and Equipment Qualification
    Accurate translation of IQ/OQ/PQ protocols, process validation reports, and calibration procedures.

Our linguists work within structured translation environments that leverage validated bilingual glossaries, client-approved terminology, and regulated style guides. This ensures consistency across all QA documents and aligns with each client’s internal quality standards.

In addition, we maintain up-to-date knowledge of global regulatory frameworks, including those of the FDA (United States), EMA (European Union), PMDA (Japan), ANVISA (Brazil), and MFDS (South Korea). Our team understands the unique documentation requirements and inspection expectations of each regulatory body, enabling us to deliver translations that are not only technically sound but also fully compliant across jurisdictions.

Read More Read Less

Multi-Step Quality Control Process

Sesen follows a rigorous multi-step quality control process to deliver translations that are accurate, consistent, and ready for regulatory or internal audits. Each project is managed through a validated workflow that mirrors the level of scrutiny applied during actual quality inspections, ensuring that all translated materials meet the highest standards of linguistic and regulatory integrity.

Our QA process includes the following stages:

Each project is assigned to a professional translator with proven expertise in life sciences and quality assurance. Translators are selected based on their language proficiency and subject matter knowledge to ensure accuracy and technical relevance.

A second qualified linguist conducts a full review of the translation to check for fidelity to the source text, linguistic clarity, and alignment with approved terminology and tone.

Our team applies validated glossaries, controlled vocabularies, and client-specific style guides to maintain consistency across all QA documentation. Formatting is reviewed to match source layouts and regulatory expectations.

A final QA check is conducted by a senior reviewer to simulate audit readiness. This includes verifying completeness, traceability, and formatting consistency across multilingual files.

Upon request, we offer back translation and reconciliation services to support risk-based validation strategies and compliance with high-risk or high-sensitivity documentation requirements.

Sesen’s structured QA process provides clients with complete confidence in the audit-readiness of their translated quality documentation, supporting smoother regulatory reviews and minimizing compliance risks. Learn more about our Quality Assurance and Terminology Management practices.

Technology-Enabled Accuracy

Sesen combines advanced language technology with subject matter expertise to deliver highly accurate, consistent, and audit-ready translations. Our translation workflows are supported by tools that streamline quality control, reduce human error, and maintain linguistic and regulatory consistency across projects.

We leverage the following technologies to enhance QA audit translation services:

Our platform utilizes translation memory to store and reuse previously approved translations, ensuring consistency across recurring content such as SOPs, validation protocols, and quality manuals. Integrated terminology management systems enforce the use of client-approved terms and controlled vocabularies to reduce variation and improve regulatory alignment.

We deploy automated linguistic and formatting QA checks to detect potential issues such as untranslated segments, terminology deviations, number mismatches, or formatting inconsistencies. These automated reviews supplement human validation and accelerate quality assurance without compromising accuracy.

All projects are managed through a secure, cloud-based environment that maintains full version control and document traceability. This infrastructure supports multilingual audit trails, role-based access, and encrypted data handling in compliance with data protection and quality system requirements.

By integrating technology into every step of the workflow, Sesen delivers translations that are not only linguistically precise but also traceable and compliant with the rigorous demands of global regulatory inspections.

Global Support for Internal and Regulatory Audits

Sesen provides comprehensive multilingual translation support to help life sciences companies prepare for internal quality audits, third-party supplier assessments, and regulatory inspections across global markets. Our specialized services are designed to meet the documentation standards and linguistic expectations of both local and international authorities.

We support audit preparation and response across a wide range of regions and regulatory frameworks, including:

Translations are available in over 150 languages to support site inspections, vendor audits, and compliance reviews. We translate quality manuals, audit findings, CAPA reports, and supplier evaluation documents for use across global operations.

Our team has experience translating inspection and audit documentation for regional regulators such as the Japanese Ministry of Health, Labour and Welfare (MHLW), the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and others. We ensure that translations reflect the regulatory terminology and formatting conventions required by each agency.

We offer expedited translation services for urgent audit preparations, including support for short-notice inspections, follow-up responses, and unannounced audits. Our scalable workflows and global linguist network allow us to deliver compliant translations on accelerated timelines without compromising quality.

Sesen enables life sciences organizations to operate confidently in multilingual regulatory environments by providing accurate, timely, and compliant translations that withstand audit scrutiny. We also support Regulatory Submission Translation for FDA, EMA, and PMDA filings.

Case Study: Fast, Compliant Translations for EMA Audit Readiness

Sesen was engaged by a global pharmaceutical manufacturer preparing for an upcoming European Medicines Agency (EMA) inspection across multiple production sites. The client required urgent translation of critical QA documentation, including Standard Operating Procedures (SOPs), equipment validation protocols, deviation reports, and CAPA documentation into five European languages.

Working within a compressed two-week timeframe, Sesen deployed a dedicated project team composed of native-speaking linguists with specialized expertise in GMP compliance and pharmaceutical manufacturing. Using translation memory tools and validated terminology databases, we ensured consistency across related documents while meeting the client’s internal formatting and quality requirements.

Our ISO-certified workflow included bilingual review, terminology compliance checks, and a final QA simulation to verify audit readiness. All deliverables were returned on schedule and were successfully submitted during the EMA inspection without requiring revision.

This project demonstrates Sesen’s ability to manage high-volume, high-urgency QA translation requests while maintaining technical precision, regulatory compliance, and multilingual accuracy under tight deadlines.

Read More Read Less

Why Choose Sesen

Sesen is the trusted partner for life sciences organizations seeking high-quality, audit-ready translation services. Our exclusive focus on the life sciences industry, combined with certified workflows and subject matter expertise, positions us as a leading provider for global quality assurance translation needs.

We specialize exclusively in pharmaceutical, biotechnology, and medical device translation. Every project is tailored to the specific linguistic and regulatory requirements of the life sciences sector.

Our translation process is fully compliant with ISO 17100, ISO 9001:2015, and ISO 13485:2016, ensuring documented quality control, version traceability, and inspection readiness across all deliverables.

Our linguists have backgrounds in quality assurance, regulatory affairs, and pharmaceutical manufacturing. We assign translators with the right technical knowledge to every project.

We provide multilingual support for FDA, EMA, PMDA, ANVISA, and MFDS audits. Our team understands the unique documentation and terminology expectations of each regulatory body.

Sesen supports top-tier pharmaceutical, biotech, and medical device firms with critical translation needs for inspections, submissions, and compliance documentation.

Our proven track record, technical precision, and regulatory fluency make Sesen the preferred choice for quality assurance audit translation services in the life sciences industry.

Let Sesen Support Your Next Audit with Expert Translation

Ensure your quality assurance documentation is accurate, compliant, and audit-ready with professional translation services tailored for life sciences.

REQUEST A QUOTE REQUEST A QUOTE
SPEAK TO AN EXPERT SPEAK TO AN EXPERT