Signatures–What’sin a Name?

签名的含义是什么？

Q. In arecent audit, we were asked about the meaning of the signatures on ourcontrolled documents. Our reply was that it clearly states that the signatoriesare either authors, reviewers, or approvers. The auditor considered ourresponse insufficient, pointing out that we often have up to 10 reviewers.Though the names and titles of these are given, their review responsibilitiesare not defined or described. We are unclear how to make the meaning of the signaturesmore precise.

问：在最近的一次审计中，我们被问及受控文件上签名的含义。我们的答复是，它明确指出，签名者是作者、审核人，或批准人。检查官认为我们的答复不够充分，指出我们往往有多达10个审核人员。虽然给出了这人的名字和职位，但没有定义或描述其审核责任。我们不清楚如何使签名的含义更加精确。

A. The regulations do not provide much detail with regards to your question. For example, the European Union guidelines (1) require, “Documents containing instructions should be approved, signed, and dated by appropriate and authorised persons.” The US regulations are a little bit more specific in21 Code of Federal Regulations (CFR) Part 11 (2) regarding the signing of electronicrecords and state, “This information must include the printed name of thesigner, the date and time when the signature was executed, and the meaning [emphasis added] (such as review,approval, responsibility, and authorship) associated with the signature.”

回答：法规没有提供你所述问题的细节。例如，欧盟指南（1）要求，"指令类文件应由适当和授权的人员批准和签名/日期。美国 21 CFR） Part 11 （2）关于电子记录则略为具体，并声明，"应包含签名者的打印名称、签名日期和时间，以及与签名相关的的含义（如审核、批准、负责人或作者） [强调]。

The question is whether the meaning of the signatures in your documents isclear enough and unambiguous. Let us look at an example, such as a cleaningstandard operating procedure (SOP) for manufacturing equipment. An author, mostlikely a member of the operations team, prepares the document. There will beseveral reviewers, possibly including manufacturing, engineering, validation,quality unit, regulatory affairs, and health and safety. These reviewers willeach have a different perspective from which they perform their review.

问题是，文件签名的含义是否足够清晰和明确。让我们看一个例子，例如生产设备的清洁标准操作程序（SOP）。作者（很可能是操作班组的成员）正在准备文件。将会有几位审核人员，可能包括生产、工程、验证、质量部门、注册部门以及健康和安全。这些审核人各自有不同的视角来执行审核。

One could argue that the role and the associated job description definesufficiently what a reviewer has to do. In theory, yes; but in practice this isoften not the case. Therefore, companies typically apply one of two approaches:either define the controlled documents review and approval responsibilities ina document (e.g., the SOP for SOPs) or add the meaning to each signature in thesignature list.

有人可能会争辩说，角色和相关的工作描述足以界定审核人需要做什么。从理论上讲，是的；但在实践中，情况往往并非如此。因此，公司通常采用两种方法之一：在文件中定义受控文件审核和批准职责（例如，SOP以概之），或者在签名表中添加每个签名的含义。

Table I is an example of such a review responsibilities matrix.

表1是此类审核责任矩阵的示例。

If we apply this to the cleaning SOP example, we would expect:

如果我们将其应用于清洁SOP 中，我们期望：

The operators to check if theinstructions can actually be performed (technical feasibility)

操作人员检查该规程是否可实际执行（技术可行性）

Managers in manufacturing to check the functionalcorrectness of the cleaning procedures (e.g., cross-referencecleaning validation reports) and to verify that the instructions are clear andlogical

生产经理检查清洁程序的功能正确性（例如，交叉引用清洁验证报告），并确认该规程是否清晰且合乎逻辑

The validation team to verify that thecleaning procedures are in concurrence with previously executed cleaningvalidations

验证组确认清洁程序是否与所执行的清洁验证一致

The quality unit to ensure that thedocument uses the correct template and format, that the procedure meetsregulatory requirements, and that any related change controls oraudit/inspection commitments have been met

质量部门确保文件使用正确的模板和格式、该程序符合法规要求以及任何相关变更控制或审查/检查已完成

The regulatory affairsdepartment to confirm that the procedure is in concurrence with themanufacturing licenses

法规注册部门确认程序与生产许可一致

The health and safety executive to checkthat all required safety precautions are applied, for example, where flammableor corrosive solvents are used.

健康和安全经理检查是否采取了所有必需的安全预防措施，例如使用易燃或腐蚀性溶剂的地方。

In summary, it is good industry practice to clarify the precise remit foreach of the reviewers of a controlled document, rather than just apply thegeneral term of ‘reviewer.’ 

总之，良好的行业做法是明确受控文件的每个审核人员的确切职责，而不仅仅是应用"审核人"这一词。

And finally: are you still sure you need up to 10 reviewers?

最后：你还确定需要多达 10 个审核人吗？