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Posted by: Terry Madigan, Posted on: 25 May 2018 - Categories: Compliance matters, Good distribution practice 类别：符合性问题，优良流通规范 https://mhrainspectorate.blog.gov.uk/2018/05/25/i-dont-believe-it/ The recently published guidance on data integrity provides an extensive description of the MHRA expectations of data integrity across the GxPs. This is not a new regulatory requirement but guidance on how to meet the requirement. Compared to other GxPs, GDP world is technically simpler, has risks that are common to other GxPs as well as some specific to pharmaceutical wholesaling. What follows are some examples of data integrity issues I have seen in my role as a GDP inspector. 最近发布的关于数据完整性的指南全面描绘了MHRA在整个GXP范围内对数据完整性的期望。这并不是新的法规要求，而只是指导如何符合要求。与其它GXP相比，GDP世界的技术更为简单，有一些与其它GXP共同的风险，也有一些在药品批发领域特有的风险。以下是在我的GDP检查员工作中看到的一些数据完整性问题的例子。 Does it matter? 这重要吗？ As an inspector, when reviewing data I ask myself ''does this data matter (i.e. is it critical) and if so, can I trust what I see?'' 作为一名检查员，在审核数据时我都会问自己“这个数据重要吗（就是说是否关键），如果是，我能相信我看到的东西吗？” When presented with a thermometer that indicates ambient storage ranges it is easy to cast doubt on a reading that shows the minimum temperature of 5°C and a maximum of 36°C. The possible explanations were easy to test. Was the thermometer calibrated? Did it show signs of damage? Did staff know how to use the device? I decided that the temperature monitoring was important in this case and I couldn’t trust the records. The thermometer turned out to be not calibrated and staff didn’t knowhow to use it. 当用一支温度计指示环境存贮范围时，如果最低温度显示5°C最高温度显示36°C很容易对读数产生怀疑。可能的解释是很容易进行测试的。温度计是否校正？温度计是否有受损的痕迹？员工是否知晓如何使用该仪表？我认为温度监测在此情形是很重要的，因此我不能相信这些记录。而最后则发现该温度未经校正，并且员工并不知晓如何使用。 Such outlying data iseasy to spot, but when we are faced with data that looks within trend we are less likely to question whether it is valid; however, the integrity of data canbe just as unreliable even though it all appears within the expected range.Poor quality of data is often unintended and may be due to poor training or useof poor equipment. 此类超常的数据很容易看出来，但如果我们面对的数据看起来在趋势范围内，我们就不太可能去质疑其有效性了。但是，即使所有数据看起来都在预期范围内，数据完整性也可能是不可信的。数据质量太差通常是无意中造成的，可能是因为培训不足或使用了不良设备导致。 One example of intended falsification of data used a weakness in a process for re-palletising stock combined with lack of oversight by the owner of the stock. A trailer of medicines was delivered to a third-party warehouse to be re‑palletised from standard to smaller pallets and shipped onwards – the pallet number andtotal gross weight were now different. It was only when the pallets were broken down at Goods In at the final destination that shortages were identified with acouple of outers missing from each pallet. This may have been avoided or detected earlier if better data governance was applied by the stock owner,perhaps using stricter control of the process, having a witness for buildingthe pallets and more detailed recording and review of records. 有一个有意对数据做假的例子，其中利用了重新打托且将货物并托过程中货主缺乏监管的漏洞。一拖车的药品要发往第三方仓库，将原来的标准托盘改为较小的托盘重新打托并发货—托盘数量和总毛重就不一样了。在货物到达最终目的地时才发现托盘破损了，每个托盘上都有一些外包装缺失了。如果货主有更好的数据管理方式，本来可以避免或早点发现这些问题，比如使用更为严格的流程控制，现场督导打托过程，并更为详细地记录和审核记录。 Criticality 关键程度 Data is critical ifit has a direct bearing on patient health or GDP compliance and cannot be reconstructed. The extent of data governance should be commensurate with the level of criticality of the data and may take the form of higher level of data review, more through process design and more attention on addressing potential causes of poor data integrity e.g.poor equipment qualification and weak quality culture. 如果数据对患者健康或GDP符合性有着直接影响且不能重新构建，则这些数据就是关键的。数据管理的深度应与数据的关键程度相适应，可以考虑更高水平的数据审核，更为深入的流程设计，更加注意解决导致数据完整性不良的潜在原因，如，设备确认不良和质量文化差。 GDP computerised systems GDP计算机化系统 The advance of computerised system and application development has enabled operators to carryout activities at an increasingly fast pace including flash transactions, sometimes without having sight of stock. The intention to use non-trackable software such as WhatsApp for quality-critical event reporting has been proposed by wholesalers – and refused on the grounds of not being capable tocomply with DI requirements; however, the use of computerised systems is encouraged providing they are appropriately qualified and controlled,especially if they are bespoke to your organisation. The GxP Data Integrity guidance provides a lot of information on this topic. 计算机化系统和应用软件开发的优点使得操作人员可以更快地执行任务，包括闪速交易，有时候都不会看到库存实物。批发商打算在质量关键事件报告中使用不可追踪软件如WhatsApp（瓦次普），但因为不能符合EI要求而被拒绝了。鼓励使用经过适当确认并受控的计算机化系统，尤其是公司订制系统。GXP数据完整性指南提供了关于此主题的不少信息。 The use of robots and electronic audit trails can lead to a false sense of security in relation todata integrity. The simple act of ensuring that stock is delivered to the right address can fail when an electronic proof of delivery signal cannot be picked up either in remote Africa or in mid-Wales and work-arounds are created.Additional problems of maintaining a full audit trail arises when stock changes from one organisation or department to another, for example delivery of a consignment through a network of third-party couriers leading to an incomplete document audit trail. Also, some couriers only retain their track and tracerecords for a few weeks before destroying them. 使用机器人和电子审核追踪可能会让人产生数据完整性很安全的错觉。如果一个电子发货信息在遥远的非洲或在威尔士中部未被捕获并创建出解决方案，确保将正确的货物发至正确的地址这样简单的动作也是可能失败的。维护全面审计追踪过程中，如果库存从一个组织或部门改到另一个，例如，通过第三国网络发送一单货物导致不完整的文件审计追踪。还有，一些货运商只是保持其跟踪追溯记录几周，然后就将其销毁了。 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 andlegible set of scanned records will mean you will not be able to trace activities and will not comply with regulations. 如果记录从一种格式转成另一种，例如，纸质副本供应商发标转成PDF，或者是纸质温度记录纸转成电子记录，然后可以由一个资深人员确认其准确度和完整性。还要评估该流程的潜在失效模式，例如，如果转化纸质供应商发标至PDF，则可能会有不止一个版本的文件（相同来源，但不同的背书号）。2个版本可能都需要保存。另外，有些双面文件可能只扫描了一面。复印此类文件可能很枯燥，通常是交给办公室新手去做的，但没有完整准确和清楚的扫描记录就意味着你无法追溯活动，也就不符合法规要求。 Do you excel? 你用EXCEL吗？ The use of spreadsheets deserves a special mention. I am a great advocate of spreadsheets for managing and presenting data, and their versatility and ease of use has ledto wide application within GDP. When data contained within the spreadsheet cannot be reconstructed elsewhere and is essential to GDP 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 numbersto graphs. 使用数据表值得大家特别关注。我是非常提倡使用数据表来管理和呈现数据的，其多样性和易于使用的特性使得其在GDP范围内被广泛使用。当数据表内含有的数据不能在其它地方重建，并且对GDP活动至关重要时，数据管理措施需要更为严格。在进行数据修约、单位转换或将数字转为图表时应特别小心。 If the spreadsheet has multiple users it may be impossible to ascertain who (Attributable) made anentry, 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). 如果数据表有多个用户，则可能无法确定是谁（归属性）输入的，是否输入的数据有被覆盖或替换（永久），是否已录入数据（同步）。如果数据表并无版本控制，作为一个受控文件来管理，则可能会有不同版本都在使用中（原始的）。如果使用了公式和其它函数，则可能会发生潜在的错误而不被察觉（准确性）。 Possible ways of gaining appropriate control include restricting the use of spreadsheets only fornon-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 ahard copy version which is version-controlled, approved and dated, locked downand man aged 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 notentered frequently such as a staff training matrix that may only be revised afew times each year or confirmation of supplier or customer authentication carried out every fortnight. 实现适当控制的可能方法有限制只允许使用非关键数据的数据表，以及锁定单元格或数据表内的页对写入权限进行限制。另一个可能的解决方案是使用数据表来创建一份纸质版本，采用版本控制，执行批准流程并写上日期，作为受控版本进行锁定和管理。在此情形下，需要使用批准后的版本作为工作文件，而不是采用未经批准的数据表来创建。如果数据录入不频繁，如员工培训数据，可能一年只有几次会进行修改，或者是供应商确认，或客户认证会每2周一次，则此方法可能会比较有用。 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. 如果在数据表内使用了宏或公式，则应定义（例如，在一个操作程序里）并测试其准确性，保护其不受未经授权的修改。确认这些不会受损应该是常规数据完整性审核的一部分。 Whether it is hardcopy or soft, having data and records you know are accurate and complete not only meets minimum GDP requirements, but surely is also the foundation with which to make sound and confident business decisions. 无论是纸质记录或软件，保有你明知是准确和完整的数据和记录并不只是符合最低GDP要求，并且肯定还是做出令人信服的合理业务决策的基础。
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发表于 2018-5-29 08:38:31
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