记录扫描、EXCEL电子表格的要求

本文为英国药监局（MHRA），作者Terry Madigan，为MHRA的检查员，有20多年的制药行业工作经历，历任制药企业的研究，开发和质量保证职能。

该文章提到如果记录从一种形式转换为另一种形式，如扫描为PDF版本，这些记录的准确性和完整性应由具有适当资质的人确认，应该针对潜在的失败模式进行评估，如可能存在多个版本的文档，或者有些双面文档可能不正确地仅被单面扫描

此外，还提到关于EXCEL电子表格的合规使用，指出如果电子表格有多个用户，是无法确定谁（可归属）进行了输入，输入是否被覆盖和替换（永久）以及何时输入数据（同步）的。

有关EXCEL合规使用的更多细节请参见GMP办公室发布的文章《EXCEL表格的合理设置和验证》

该文章摘译如下：

Where records are converted from one form to another, e.g. hard copy supplier invoices converted to pdf, or hard copy temperature records transcribed into an electronic record, then these should be confirmed as being accurate and complete by a person of appropriate seniority. This process should also be assessed for potential failure modes, for example when converting hard copy supplier invoices to pdf there may be more than one version of the document (same original but with different annotations on it). Both versions may therefore need to be retained. In addition, some double-sided documents may incorrectly be only scanned single-sided. Copying such documents can be tedious and is often delegated to an office junior, but the implications of not having a complete, accurate and legible set of scanned records will mean you will not be able to trace activities and will not comply with regulations.

如果记录从一种形式转换为另一种形式，例如将供应商发票转换为pdf，或将温度记录转换成电子记录，那么这些记录的准确性和完整性应由具有适当资质的人确认。这个过程也应该针对潜在的失败模式进行评估，例如，当将硬拷贝供应商发票转换为pdf时，可能存在多个版本的文档（原始版本相同，但有不同的附注）。因此这两个版本都需要保留。另外，有些双面文档可能不正确地仅被单面扫描。复制这样的文件可能是乏味的，并且经常被委派给初级办公室新人，但是扫描记录不完整准确可读将意味着你将不能追溯活动并不符合法规。

Do you excel?

你是否使用EXCEL

The use of spreadsheets deserves a special mention. When data contained within the spreadsheet cannot be reconstructed elsewhere and is essential to GxP activity then the data governance measures need to rigorous. There needs to be caution when number-rounding, converting from one unit of measure to another or from numbers to graphs.

电子表格的使用值得特别提及。如果电子表格中的数据无法在其他地方重新构建并且对GxP活动至关重要，那么就需要严格的数据治理措施。数字取舍、从一个测量单位转换到另一个测量单位或从数字转换为图形时需要注意。

If the spreadsheet has multiple users it may be impossible to ascertain who (Attributable) made an entry, whether entries have been over-written and replaced (permanent), and when the data entries had been made (Contemporaneous). If the spreadsheet is not version-controlled and managed as a controlled document, then there may be different versions in use (Original). Where formulae and other functions are used there is potential for these to be corrupted without being detected (Accurate).

如果电子表格有多个用户，则可能无法确定谁（可归属）进行了输入，输入是否被覆盖和替换（永久）以及何时输入数据（同步）。如果电子表格不受版本控制并作为受控文档进行管理，则可能存在不同的正在使用的版本（原始版本）。在使用公式和其他功能的情况下，若没有进行保护，可能出现错误（准确）。

Possible ways of gaining appropriate control include restricting the use of spreadsheets only for non-critical data and locking down cells or sheets within it so write access is restricted. Another potential solution is to use the spreadsheet to create a hard copy version which is version-controlled, approved and dated, locked down and managed as the controlled version.  In this case it is the approved version that needs to be used as the working document, not the unapproved spreadsheet used to create it.  this approach can be useful when data is not entered frequently such as a staff training matrix that may only be revised a few times each year or confirmation of supplier or customer authentication carried out every fortnight.

适当控制的可能方法包括限制仅用于非关键数据的电子表格的使用，以及锁定其中的单元格或表单，以便限制写入访问。另一个可能的解决方案是对电子表格进行版本控制，批准和生效，锁定并作为受控版本进行管理。在这种情况下，仅可以使用经批准的版本作为工作文档，而不是用于创建它的未经批准的电子表格。这种方法在不需要经常输入数据的情况下非常有用，例如每年只需要修改几次的员工培训矩阵或每两周进行一次供应商或客户认证的确认。

Where Macros or formulae are used within a spreadsheet these should be defined (e.g. within an operating procedure), tested for accuracy and protected against unauthorized changes.  Confirming these are not corrupted should be part of regular data integrity review.

如果在电子表格中使用宏或公式，应定义这些宏（例如在一个操作规程中），测试其准确性并防止未经授权的更改。确认这些宏没有被破坏应该是定期数据完整性审核的一部分。