实验室数据完整性要点解析

实验室数据完整性要点解析

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。