Has the validation program been thoroughly documented?
确认方案已经彻底地形成档案了吗？

The validation should be done in accordance with written qualification protocols and the results should be recorded in the qualification reports.
验证必须遵循已获得批准的方案，结果记录在确认报告中。

You will need it for warranty validation.
你将需要用它来保证验证。