本文以實(shí)驗室數據審核為例，結合相關(guān)法規和指南的要求，探討審計追蹤審核的行業(yè)最佳實(shí)踐，不當之處請大家批準指正。
在展開(kāi)這個(gè)問(wèn)題前，首先分享一張色譜分析流程圖，圖片來(lái)自PDA TR80實(shí)驗室數據完整性管理系統：
從流程圖中可以看出數據審核是是數據分析完成后、對外發(fā)布（放行）前的關(guān)鍵環(huán)節，而審計追蹤的審核又是數據審核中至關(guān)重要的一部分。
以色譜分析為例，讓我們看一下色譜分析檢測中有哪些審計追蹤：
對于色譜分析來(lái)說(shuō)，審計追蹤主要分為以下幾類(lèi)：
1、系統審計追蹤（PDA 80 中建議QA應定期審核系統的審計追蹤）
2、文件夾審計追蹤
3、方法、序列、結果審計追蹤
這些審計追蹤在數據發(fā)布前應都應進(jìn)行審核，審計追蹤的審核由誰(shuí)來(lái)進(jìn)行？是否必須由QA進(jìn)行審核？是接下來(lái)要與大家探討的點(diǎn)。
我們先看一下法規和指南中的規定：
1、FDA DI問(wèn)答 Who should review audit trails?
Audit trail review is similar to assessing cross-outs on paper when reviewing data. Personnel responsible for record review under CGMP should review the audit trails that capture changes to data associated with the record as they review the rest of the record (e.g., §§ 211.22(a), 211.101(c) and (d), 211.103, 211.182, 211.186(a), 211.192, 211.194(a)(8), and 212.20(d)).
FDA數據完整性問(wèn)答中對于該問(wèn)題有明確的回復"按照CGMP相關(guān)條款，負責審核記錄的人員應該審核審計追蹤"，其中194實(shí)驗室記錄部分，具體的規定如下
21CFR PART 211.194 Lab Records
(a) Laboratory records shall include complete data derived from all tests necessary to assure compliance with established specifications and standards, including examinations and assays, as follows：
The initials or signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
實(shí)驗室記錄應該包括完整數據的信息：原始記錄的準確性、完整性、標準符合性第二人審核的簽名。
2、EU GMP
The date and signature of a second person showing that the original records have been reviewed for accuracy, completeness, and compliance with established standards.
實(shí)驗室記錄應該包括完整數據的信息：原始記錄的準確性、完整性、標準符合性第二人審核的簽名。
3、WHO 良好文件數據規范：
Supervisors responsible for reviewing electronic data should learn which audit trails in the system track significant data changes and how these might be most efficiently accessed as part of their review.
負責審核電子數據的實(shí)驗室主管應掌握審計追蹤與關(guān)鍵數據修改的對應關(guān)系。
4、MHRA數據完整性指南
Reviewers should have sufficient knowledge and system access to review relevant audit trails, raw data and metadata (see also 'data governance').
審核員應具備足夠的知識和系統權限來(lái)審核相關(guān)的審計追蹤、原始數據和元數據（也參見(jiàn)"數據管理"）
5、PIC/S 數據完整性指南
Laboratory records for testing steps should also be reviewed by designated personnel (e.g.: second analysts) following completion of testing. Reviewers are expected to check all entries, critical calculations, and undertake appropriate assessment of the reliability of test results in accordance with data-integrity principles.
在完成檢測后，還應由指定人員（例如：第二分析員）審核檢測步驟的實(shí)驗室記錄。審核員應根據數據可靠性原則檢查所有條目、關(guān)鍵計算，并對檢驗結果的可靠性進(jìn)行適當的評估。
Companies should implement procedures that outline their policy and processes to determine the data that is required in audit trails, and the review of audit trails in accordance with risk management principles. Critical audit trails related to each operation should be independently reviewed with all other records related to the operation and prior to the review of the completion of the operation (e.g. prior to batch release) so as to ensure that critical data and changes to it are acceptable. This review should be performed by the originating department, and where necessary verified by the quality unit, e.g. during self-inspection or investigative activities.
公司應實(shí)施概述其政策和流程的規程，以確定審計追蹤所需的數據，并根據風(fēng)險管理原則審核審計追蹤。每項操作相關(guān)的關(guān)鍵審計追蹤應與該操作的所有其它記錄一起獨立核查，并在該操作的完成情況審核之前（例如，在批放行之前）進(jìn)行，以確保關(guān)鍵數據及其更改是可接受的。審計追蹤的審核應由數據產(chǎn)生部門(mén)進(jìn)行，必要時(shí)由質(zhì)量部門(mén)核實(shí)，例如：在自查或調查活動(dòng)中。
綜合以上法規和指南的要求，總結分析如下：
1、審計追蹤的審核應該與相關(guān)的記錄一并進(jìn)行審核，可由數據產(chǎn)生部門(mén)進(jìn)行審核。
2、企業(yè)應基于風(fēng)險的控制，對于關(guān)鍵性的數據的審計追蹤由質(zhì)量部門(mén)（QA）定期核查。
3、以色譜分析為例：審計追蹤由實(shí)驗室第二人進(jìn)行審核，同時(shí)對于系統層面的審計追蹤，QA定定期進(jìn)行檢查。
作者簡(jiǎn)介：
Windshower，就職于國內大型制藥企業(yè)，十五年以上實(shí)驗室工作經(jīng)驗，數據完整性主題專(zhuān)家，多年質(zhì)量管理經(jīng)驗，精通QC相關(guān)藥典法規知識，多年國內外審計認證經(jīng)驗。
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