Life Sciences Solution

Localization Built for
Regulated Workflows

Audit-ready localization for clinical trials, regulatory submissions, Clinical Outcome Assessments, and patient-facing content. Built for pharma, biotech, MedTech, and CROs who need the platform to hold up under regulator scrutiny.

Start Free TrialTalk to Sales

Why Regulated Localization Is Different

Regulated Content Carries Risk, So the Platform Has to Hold Up

Validated, Not Just Translated

Trials and COAs demand forward translation, back-translation, and reconciliation. Wordbee runs that chain as configurable workflow steps, not a manual handoff between tools and inboxes.

Controlled Language

Approved terminology and mandatory QA gates keep off-label, inconsistent, or non-compliant wording out of patient-facing and regulatory content before it ever ships.

Provable After the Fact

Every change, reviewer, and version is captured in an exportable audit trail, with access scoped to exactly who should see what, ready for the submission or the audit.

Configurable Workflows

Build Your COA and Back-Translation Chain on a Template

Workflow templates run the regulated validation chain for you: forward translation, back-translation, reconciliation, and review in the sequence your SOPs require, with per-language rules and conditional steps.

Linguistic Validation · Workflow Template
  6. Every document follows the same validated path

Step 1 · Translate

Forward Translation

One or more linguists translate the source. Translation memory and approved terminology feed the editor so wording is consistent from the first pass.

At this step

  • Assign to in-house, freelance, or LSP suppliers
  • Live termbase suggestions during translation
  • Per-language rules within a single project
Learn More About Workflows

Quality Assurance

QA Engineered for Regulated Content

Errors are risk, not rework. Configure your QA profile once and apply it across every project. Run checks on demand, before delivery, or on a schedule. Block job completion until issues are resolved or explicitly overridden.

  • 25+ configurable QA rule types per profile
  • Terminology consistency at 50–100% similarity thresholds
  • Up to 600 forbidden terms per profile
  • Regex pattern matching for codes, part numbers, and identifiers
  • Tag and markup verification across source and target
  • Mandatory QA gates that block completion until errors clear
  • Cumulative QA results preserved across runs for full audit
  • QA reporting at the segment, job, and project level
See How Quality Assurance Works→
QA Workflow Gate
Blocks on Errors
2 errors, held at the gate
Nothing ships with errors. Critical issues hold the job at the gate until they're resolved.

Traceability and Access

Prove Who Did What, and Control Who Sees It

Every login, change, upload, and assignment lands in an exportable Activity Log, and every user is scoped to exactly what they should touch. The answer to an audit or an access review is always one export away.

  • Segment revision history through a Draft, Confirmed, Rejected status cycle, with batch undo
  • Activity Log at Settings → Activity Log, filterable by user, date, and event, exportable for submissions
  • 125 access rights, six inhouse and five external templates, with project- and resource-level scope
  • SAML 2.0 single sign-on with ADFS, Microsoft Entra, Google, and Okta
  • Multi-factor authentication with administrator reset and email fallback
  • Per-user API keys inherit permissions; tokens expire after 30 minutes
See Security and Certifications→
Audit Trail
Exportable
Sign-in
File upload
API call
Status change
Activity LogExport
  • 09:12Jane DoeSigned in
  • 09:14Jane DoeUploaded source.xliff
  • 09:15systemAPI export · /v1/jobs
  • 09:18Max MustermannStatus → Delivered
Every action, on the record. User and system events flow into one timestamped, filterable, exportable log.

The Full Picture

Everything the Security and Procurement Review Will Ask About

The capabilities that clear a regulated vendor assessment, governed in one platform.

Security and Compliance

  • ISO 27001 certified information security management
  • GDPR compliant, with a signed DPA and sub-processor list on request
  • Regular third-party penetration testing, summary under NDA
  • AES-256 encryption at rest, TLS 1.2 or higher in transit
  • SOC 2 Type II audit in progress

Data and Hosting

  • Microsoft Azure data centers in the European Union or the United States
  • Data stays in the region you select
  • Dedicated single-tenant hosting available for enterprise
  • Automated, encrypted backups with geographic redundancy

Terminology and Files

  • Termbase lifecycle: Unprocessed → Provisionally Processed → Finalized
  • Subject-field tagging to separate medical, clinical, and regulatory vocabularies
  • 40+ file formats, including multi-sheet Excel for clinical data
  • Column targeting and per-row character limits read straight from a sheet
Talk to Sales About Your Security Review

Frequently Asked

Questions Regulatory Teams Ask Us

Ready to See Wordbee for Life Sciences?

A working session with our team, who understand regulated workflows, audit requirements, and the realities of clinical and regulatory localization.

Start Free TrialTalk to Sales