Validation验证
Validation is the documented process of confirming that a procedure, system, equipment, or analytical method consistently produces results that meet predetermined specifications and quality attributes. In life-science translation and localization, the term appears in process validation plans, computer-system validation reports, cleaning validation protocols, and regulatory dossiers that describe how a manufacturer demonstrates controlled performance.
Updated
Angel Translation editorial reference · Confirm the rendering against your source and approved project terminology.
Check source meaning → confirm the preferred term → record approved variants and references.
Where this term appears
Validation content appears in SOPs, validation master plans, installation/operational/performance qualification documents, and audit responses translated for manufacturing sites, laboratories, and software vendors. Translators must preserve the separation between validation, qualification, and verification, especially when those terms appear together in tables, checklists, protocols, and compliance narratives.
Translation checks
One common mistake is translating validation as “testing” or “approval,” which narrows or shifts its regulatory meaning. Another is using the same target term for validation, qualification, and verification; in life-science quality systems these are related but distinct activities, and conflating them can misstate what evidence exists for a process or system.
Chinese document application
Validation in context · validation plan
- English source
- Define the intended use before validation.
- Chinese rendering to review
- 在确认前明确预期用途。
Illustrative wording only. Confirm the rendering against the actual source and approved project terminology.
Check the distinction in context
Validation and verification can require different Chinese renderings in a controlled terminology system. Use the organization’s approved distinction and the source context. Avoid alternating terms merely because a dictionary lists both as possible translations.
Check the returned Chinese file
Compare the translated title, activity description and report heading. The agreed Chinese rendering of validation should stay consistent with the documented concept, while a separately defined verification activity retains its own approved term.
Prepare the connected files
Send the approved terminology, plan and relevant acceptance wording. The technical owner should confirm the intended concept before the same term is applied across the file set.
Keep the term aligned across your files
Check intended use, warnings, document versions and approved terminology with the project team. Translation supports documentation; it does not establish product approval or regulatory acceptance.
Provide approved terms and previous translations with the source files. Agree how variants, ambiguous wording and revisions will be reviewed. Terminology maintenance and any termbase handback are confirmed in the project scope. See the 8-step AI + expert workflow.
Related document experience
NIPRO Medical (Hefei)
Chinese → EnglishMedical-device registration files and technical specifications, in volume.
Read the published project →
Walvax Biotechnology
Chinese → EnglishVaccine-production process documentation, SOPs, quality-control standards and microbiology-testing procedures.
Read the published project →Published scope shows related industry experience; it does not confirm that this specific term was used or reviewed in the project.
Working on life science documentation?
Include the source and target languages, file types, intended use, deadline and any approved termbase. Agree handling before sending sensitive files. Acknowledged in 4 hours, quoted in 24.
Prepare an inquiry email →Life Science solutions →File handling →A glossary entry is not an official standard or evidence of regulatory acceptance. Confirm current requirements for your project separately.