分析能为您提供什么
一份证书要么支持某项决定，要么不支持。报告会明确说明是哪一种，并展示其推理过程。
经得起质证的结论
每项结论都包含所依据的要求、观察到的证据、推理过程、来源及版本，以及解决该问题所需的行动。
拒绝猜测，只给结论
当证书所载证据不足以得出结论时，报告会明确说明并指出缺失内容。一个自信但错误的答案，比没有答案更危险。
可复现的记录
每次分析都会保存所用的引擎、来源版本及规则指纹，因此数月前生成的报告仍可追溯至其生成时所依据的确切基础。
适用人群
制药生产商
在物料放行投入生产前，检查其到货证书。
进口商与经销商
在采购和清关前，检查供应商证书。
实验室与合同研发生产机构（CDMO）
在不同分析员和班次之间提供一致的复核。
监管机构
对提交的证书提供结构化、可关联证据的审查视图。
来自知识中心
What must a certificate of analysis for an API contain?
The elements ICH Q7 expects on a certificate of analysis for an active pharmaceutical ingredient: identity of the material and batch, the dates, every test with its limit and result, and a dated signature from the quality unit with the manufacturer's details.
Retest date or expiry date: what is the difference, and what should a COA show?
The two dates mean different things. An expiry date is the point after which a material should not be used; a retest date is the point at which it should be re-examined. ICH Q7 defines both and says which should appear on a certificate of analysis.
Can a manufacturer rely on a supplier's certificate of analysis instead of testing?
Partly, and only under conditions. US, EU and ICH requirements all allow a supplier's certificate to replace some in-house testing, but each insists on an identity test of every batch, on establishing the reliability of the supplier's results, and on confirming them at intervals.