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CFDA《藥品數(shù)據(jù)管理規(guī)范（征求意見稿）》：

第二十條【審計追蹤審核】應(yīng)當(dāng)對審計追蹤進行審核，審核的頻率和內(nèi)容應(yīng)當(dāng)基于風(fēng)險級別確定。

涉及直接影響患者安全或產(chǎn)品質(zhì)量的關(guān)鍵數(shù)據(jù)更改（如最終產(chǎn)品檢驗結(jié)果、測試樣品運行序列、測試樣品標(biāo)識、關(guān)鍵工藝參數(shù)的更改等），應(yīng)當(dāng)在做出決定前對更改的數(shù)據(jù)及其審計追蹤一并進行審核。

正如紅色字體所述，CFDA要求審計追蹤的頻率應(yīng)基于風(fēng)險級別確定，并明確規(guī)定對直接影響患者安全或者產(chǎn)品質(zhì)量的數(shù)據(jù)（如批檢驗數(shù)據(jù)）應(yīng)在對作出決定（如放行前）前進行審計追蹤的審核。

如何應(yīng)用風(fēng)險確定審計追蹤的頻率呢？以下提供了范例供大家參考：

RISK BASED APPROACH

基于風(fēng)險的方法

A risk based approach to audittrail reviews is critical for an implementation that provide a meaningfulprocess without having a negative impact on cost and resources. The fact isthat without taking a risk based approach audit trail reviews can have anegative impact on cost and resources. Audit trail reviews for GxP systems area time consuming activity that requires resources to execute and manage theinformation an actions related to the review.

基于風(fēng)險的審計追蹤審核的方法是非常重要的實現(xiàn)，提供一個有意義的過程，而無需對成本和資源的負面影響。事實上，審計追蹤的審核若不采取基于風(fēng)險的方法可能對成本和資源有負面影響。GXP系統(tǒng)的審計追蹤審核是一個耗時的活動，需要資源來執(zhí)行和管理需要審核的活動相關(guān)的信息。

In order to take a risk basedapproach to audit trail reviews the system risk level need to be identified.Prioritizing the audit trail assessment based on the level of risk is criticalto prioritize the assessments and implementation. Systems involved in thetesting of Critical Quality Attributes are high risk and should be the highestpriority during the assessments and implementation.

為了采取基于風(fēng)險的審計跟蹤審核，需要確定系統(tǒng)的風(fēng)險水平。按照系統(tǒng)的風(fēng)險水平關(guān)鍵程度的優(yōu)先級別，來評估和實施。參與關(guān)鍵質(zhì)量屬性的測試系統(tǒng)是高風(fēng)險的，應(yīng)在評估和實施過程中最高優(yōu)先考慮。

The system risk level shouldbe used to establish the frequency and scope of the audit trails periodicreviews. For high risk systems such as those used in Quality Control the audittrails should be reviewed with the test results to ensure the integrity of thetest data. The scope of this review should include assessing the accuracy andintegrity of the data using the audit trail. In this situation the audit trailwill be reviewed for the following:

系統(tǒng)風(fēng)險水平應(yīng)該被用來建立審計追蹤定期審核的頻率和范圍。對于那些高風(fēng)險的系統(tǒng)，如用于質(zhì)量控制的，審計追蹤應(yīng)該與測試結(jié)果一起審核以確保試驗數(shù)據(jù)的完整性。這種審核的范圍應(yīng)包括使用審計跟蹤評估數(shù)據(jù)的準(zhǔn)確性和完整性。在這種情況下，審計追蹤將審核以下：

       數(shù)據(jù)修改

• Analyst actions

  分析人員的行為

• Data manipulation

  數(shù)據(jù)篡改

• Excessive integration of chromatography peaks

  色譜峰不合理積分

• Security breaches related to data

  與數(shù)據(jù)相關(guān)的安全漏洞

QC procedures need to definethe controls related to data integrity; this will ensure consistency during theaudit trail review.

QC程序應(yīng)該定義數(shù)據(jù)完整性相關(guān)的控制；這將確保審計跟蹤審核過程中的一致性。

For medium and low risksystems the approach will be less intensive that for high risk. For thesesystems it can be possible to review periodically the audit trails. Theperiodic review period should be established based on the level of system risk.Medium risk systems should be reviewed more frequently than low risk systems.For example a document management system is probably medium risk that should beon a periodic review schedule of every six months or a yearly schedule. Lowrisk system can be reviewed on a yearly or bi-annual basis.

對于中、低風(fēng)險的系統(tǒng)，審計追蹤的方法將沒有高風(fēng)險系統(tǒng)那么密集。這些系統(tǒng)可能定期審核審計追蹤。定期審核的周期應(yīng)根據(jù)系統(tǒng)風(fēng)險水平建立。中等風(fēng)險的系統(tǒng)應(yīng)該比低風(fēng)險的系統(tǒng)更頻繁。例如，文檔管理系統(tǒng)可能是中等風(fēng)險，應(yīng)定期計劃每六個月或每年進行。低風(fēng)險的系統(tǒng)可以每年或每年2次進行。

The scope of the audit trailreviews for medium and low risk systems should include the following:

對中、低風(fēng)險的系統(tǒng)審計追蹤的范圍，應(yīng)包括以下內(nèi)容：

• Data changes

  數(shù)據(jù)的變化

• Data deletions

  數(shù)據(jù)刪除

• Unauthorized access or transactions

  未經(jīng)授權(quán)的訪問或操作

To implement audit trailreviews is critical to take a risk based approach. A one size fits all approachcan have a significant impact on cost and resources.

實施審計追蹤的審查是采取一種基于風(fēng)險的方法的關(guān)鍵。它是一個放之四海而皆準(zhǔn)的方法，可能對成本和資源有重大影響。

In summary a risk basedapproach is critical for the implementation of audit trail periodic reviews.

綜上所述，基于風(fēng)險的方法是實施審計追蹤定期審核的關(guān)鍵。

IMPLEMENTATION

實施

Once the audit trailassessment are performed, system risk identified and all corrective actions areclosed the audit trail reviews can be implemented. Prior to implementation theimpact to resource need to be well understood based on the expected volume ofwork. Once this impact is understood hiring and reassigning of resource need tobe completed prior to formal implementation.

一旦進行審計追蹤評估，識別出系統(tǒng)的風(fēng)險并且所有糾正措施已關(guān)閉嗎，就可以實施審計追蹤的審核了。在實施之前，應(yīng)該基于所期望的工作量好好理解對資源的影響。一旦理解這種影響，應(yīng)該在正式實施之前完成資源的征用和重新分配。

Procedure may need to becreated or revised to include the approach of audit trails reviews for eachsystem based on the results of the assessment and system risk.

應(yīng)該建立或修訂規(guī)程，根據(jù)風(fēng)險評估的結(jié)果將每個系統(tǒng)的審計追蹤的審核寫進去。

The last step is training allimpacted resources on the applicable procedures with an emphasis of dataintegrity.

最后一步是培訓(xùn)所有有關(guān)人員應(yīng)用規(guī)程強調(diào)數(shù)據(jù)完整性。