实验室数据完整性

实验室数据完整性

The enduring assets of a laboratory’s work are the records that documentthose activities. When laboratory records are used to support a regulatoryfunction, they are considered to be legal documents. It is of criticalimportance that data integrity is understood and adhered to by everyone workingin the laboratory environment.

确保实验室工作被记录形成文档的这些活动，当实验室记录被用于支持法规要求，它被认为是一个法规文件，数据完整用于了解实验室环境中每个工作人员的情况是非常重要的。

All it takes is one kink in the chain to destroy your laboratory’sreputation

所有情况的发生都可能破坏你实验室的可信度

For records to be considered reliable and trustworthy, they must complywith the following criteria:

记录应该是可靠和可信的，他必须符合以下关键点：

• Legible and Understandable 易读易懂
• Attributable 归属
• Contemporaneous 同步
• Original 原始性
• Accurate 正确性
• Complete 完整性
• Consistent 一致性
• Indelible 不可随意消除
• Available 可用
  
  

Legible andUnderstandable

易读易懂

A record that cannot be read or understood has no value and might as wellnot exist. All records should be composed so they conform to grammaticalconvention which should be consistent throughout.

一份记录不能被阅读或者理解，那么他就是没有价值的或者是不存在。所有记录应该符合语法并且连续通顺。

It is best to avoid buzzwords, cliques and slang as these are prone tochange with time and are often not understood outside a particular locality. Itis always good practice to have any record reviewed by a second person as thiscan often highlight any ambiguities.

最好避免行话或者哩语，以避免随着时间的改变而不能理解当时的特殊说法，通常好的做法是任何记录都由第二个人进行复核。

Attributable 归属

Attributable, The identity of the person creating a record should bedocumented. For paper records this is normally done by the individual signingand dating the record with their signature.

As the record you may be signing may be a legal document, you shouldclearly understand the implication of your signature.

归属，人员起草的记录应该被文件化，用纸张记录他平常做的事情，通过在这些记录上签名和记录日期。

A signature should be individual to a specific individual and the practiceof signing someone else’s name or initials is fraud, and is taken veryseriously.

签名应该本人签名，如果代签或者代签某人的缩写，被认为是欺诈行为，它是非常严重的做法。

Contemporaneous 同步记录数据

All records must be made at the time an activity takes place. Delayingwriting up, for example until the end of the day, will inevitably affect theaccuracy of that record as details can be forgotten or miss-remembered.

所有的记录必须是在时间发生的时间和地点被同步记录。推迟记录，如直到这一天下班，可能导致影响记录的准确性，因为可能会忘记或者不能完全及其所有的东西。

Original 原始性

All records must be original; information must be recorded directly ontothe document. This avoids the potential of introducing errors in transcribinginformation between documents.

所有的记录必须是原始的，信息必须被直接记录到文档中。以避免在抄录信息的过程中出现错误的可能。

If information from an instrument is printed out, by the instrument, thatprintout is the original record and should be signed, dated and attached to therecord.

如果信息是从仪器中被打印出来的。这份原始打印记录应该被签上姓名、日期和相关附件附入这份记录中。

Accurate 准确性

The record must reflect what actually happened. Any changes should be madewithout obscuring or obliterating the original information, the use of whiteoutor correction fluid is prohibited.

Any changes made to a record should be signed by the person making thechange and dated to show when it was made and a written explanation should alsobe provided.

Remember, the record may be needed after you have left the company andcannot be contacted for clarification.

记录必须反应出实际发生了什么，任何变更应该没有覆盖或者删除原始信息，禁止使用涂改液或者修正液。

任何变更应该由当事人进行记录，说明做出变更的日期、时间，并解释为什么变更。

记住，即使当事人离开公司后，这份记录都能够很清楚被所有接收人解释，

Complete完整性

The record must contain all information associated with the analysis ofthe sample, including system suitability tests, injection sequences, processingmethods, sample preparation procedures and results.

This must also include any reinjections or repeat analysis performed onthe sample.

Remember the position of the regulatory authorities for something thatneeds to be done is – ‘if it isn’t documented it’s a rumour’.

However, failing to disclose reanalysis or reinjection of samples willundermine confidence in the reliability of the records.

记录必须包含所有样品分析的信息，包括系统适应性测试，进针频次，过程分析，样品准备过程和结果。

必须同时包括重新进针或者重新分析样品的过程。

记住监管部门的立场--“如果没有记录，那么这就是一个谣言”

Consistent 一致性

Consistency in this context refers to the sequence of the componentevents, which the analytical method comprises, being performed in a logicalorder.

For example it is not possible to commence the HPLC run before the sampleshave been prepared, therefore the balance printout for the sample weightsshould be date/time stamped at least one or two hours prior to the sampleinjection time, to allow time to prepare the samples.

Therefore all date/time stamps should be in the expected sequence.

In order to avoid confusion in this respect, it is worth ensuring allinstruments that produce date/time stamped printouts are time synchronised.This is best done by reference to a standard reference time, such as a nationalonline time server.

一致性指的是有一定的序列性，分析方法是在一定的逻辑顺序下进行的。

如你不可能在样品配制前，就进行HPLC样品监测。因此，进样前，样品称量应该有时间签名，至少应该有1到2个小时的样品准备时间。

因此，所有的时间显示样品按照期望的序列进行检测。

以避免在这方面的困扰，这个值得所有一起打印出来的时间和输出时间是同步的，最好有一个标准时间作为对比，如国家网络时间。

Indelible不可磨灭

Indelible means the record must be legible for the lifetime of the recordand once it has been made it cannot be removed.

不可磨灭是指记录必须清晰的，一但产生不得被随意删除。

Hand written entries of information should be made in ink and not pencilwhich can be erased

手写记录应该是油墨书写，而不是铅笔书写。

If printouts are made on thermal paper, which darkens with time, aphotocopy should be made; this should be certified as an accurate copy of theoriginal print and attached

如果是打印的是热敏纸，为防止时间推移产生不清楚，应该有复印件附于相应原件后。

If print outs are attached to a page they should be:

如果打印后作为附页的应该：

• Secured to the page withacid free glue and industrial strength Sellotape
• Signed and dated across theattachment and the page
• Annotated with a referenceto the document
• 固定到页面后，应该无酸胶或者双面胶。
• 签名和日期跨越了该页。
• 参考文献需要进行注释。
  
  

Available 可用的

All records should be available for inspection, audit and review for thelifetime of the document.

If a document is requested during a regulatory audit, it should beproduced within thirty minutes.

Therefore, the laboratory should establish an easy to reference archive system.Records should be archived so as to preserve their integrity, such as

所有的记录应该可用于检查，审计和文件生命周期中可审核。

如果文件需要接受法规审计，它应该在30分钟内被提供。

因此，实验室应该建立一个简单的参考索引系统，记录应存档，如：

• Secure facility withrestricted access
• Effective fire suppression
• Protection from dampness orhumidity
• Controlled access toDocument
• 通道内应有安全措施。
• 有效的防火措施
• 防潮
• 控制文件借阅
  
  

来源：齐力佳

楼主辛苦了，谢谢