MHRA GMP Data Integrity 中英文

1、MHRA GMP Data Integrity Definitions and Guidance for Industry January 2015MHRA GMP 數(shù)據(jù)完整性定義和行業(yè)指導(dǎo)原則 1 月 2015簡述:Data integrity is fundamental in a pharmaceutical quality system which ensures that medicines are of the required quality. This document provides MHRA guidance on GMP data integrity expectati

2、ons for the pharmaceutical industry. This guidance is intended to complement existing EU GMP, and should be readin conjunction with national medicines legislation and the GMP standards published in Eudralex volume4.數(shù)據(jù)完整性是制藥質(zhì)量體系確保藥品質(zhì)量的基石。本文提供了MHRA 對制藥行業(yè)GMP 數(shù)據(jù)完整性的指導(dǎo)原則。本指導(dǎo)原則旨在對現(xiàn)有EU GMP 進行補充說明，需結(jié)合國家藥品法規(guī)

3、及GMP 標準內(nèi)Eudralex 第四冊進行閱讀理解。The data governance system should be integral to the pharmaceutical quality system described in EU GMP chapter 1. The effort and resource assigned to data governance should be commensurate with the risk to product quality, and should also be balanced with other quality ass

4、urance resource demands. As such, manufacturers and analytical laboratories are not expected to implement a forensic approach to data checking, but instead design and operate a system which provides an acceptable state of control based on the data integrity risk, and which is fully documented with s

5、upporting rationale.數(shù)據(jù)管理體系需要結(jié)合在EU GMP 第一章描所述的質(zhì)量體系中。投入到數(shù)據(jù)管理的精力和資源應(yīng)與對應(yīng)產(chǎn)品質(zhì)量風險相稱，同時也應(yīng)權(quán)衡其他質(zhì)量保證工作的資源需求，從而進行合理分配。因此，生產(chǎn)企業(yè)和分析實驗室不是對數(shù)據(jù)進行刻板的核對，而是要設(shè)計并運行一個對數(shù)據(jù)完整性風險可控的管理體系，并完整地記載這樣設(shè)計和運行的支持性理由。Data integrity requirements apply equally to manual (paper) and electronic data. Manufacturers and analytical laboratories

6、 should be aware that reverting from automated / computerised to manual /paper-based systems will not in itself remove the need for data integrity controls. This may also constitute a failure to comply with Article 23 of Directive 2001/83/EC, which requires an authorization holder to take account of

7、 scientific and technical progress and enable the medicinal product to be manufactured and checked by means of generally accepted scientific methods.數(shù)據(jù)完整性的要求同時適用于手工（紙質(zhì)）數(shù)據(jù)和電子數(shù)據(jù)。生產(chǎn)企業(yè)和分析實驗室要意識到從自動/電腦系統(tǒng)回歸到手動/紙質(zhì)記錄體系，其本身并不會消除對數(shù)據(jù)完整性進行控制的要求。而且這也可能造成不符合條款2001/83 / EC 第23 條需要考慮科學和技術(shù)發(fā)展程度的要求，因為該要求企業(yè)確保藥品能夠以普遍接受的

8、科學方法進行生產(chǎn)和檢驗。Throughout this guidance, associated definitions are shown as hyperlinks.本指導(dǎo)原則所涉及的相關(guān)定義以超級鏈接連接的方式出現(xiàn)。Establishing data criticality and inherent integrity risk:建立數(shù)據(jù)的關(guān)鍵程度和內(nèi)在的完整性風險：In addition to an overarching data governance system, which should include relevant policies and staff training

9、in the importance of data integrity, consideration should be given to the organisational (cedures) and technical (e.g. computer system access) controls applied to different areas of the quality system. The degree of effort and resource applied to the organisational and technical control of da

10、ta lifecycle elements should be commensurate with its criticality in terms of impact to product quality attributes.除了一個包括對確保數(shù)據(jù)完整性至關(guān)重要的相應(yīng)政策和人員培訓的總體數(shù)據(jù)管理體系，同時應(yīng)考慮在不同質(zhì)量體系領(lǐng)域?qū)?gòu)建性（如操作程序）和技術(shù)性（如計算機系統(tǒng)訪問權(quán)限）控制手段的應(yīng)用。對數(shù)據(jù)生命周期中各要素進行構(gòu)建性和技術(shù)性控制的程度，要與其對產(chǎn)品質(zhì)量屬性影響關(guān)鍵程度相對應(yīng)Data may be generated by (i) a paper-based record of

11、a manual observation, or (ii) in terms of equipment,a spectrum of simple machines through to complex highly configurable computerised systems. The inherent risks to data integrity may differ depending upon the degree to which data (or the system generating or using the data) can be configured, and t

12、herefore potentially manipulated (see figure 1)數(shù)據(jù)可由以下幾種情況產(chǎn)生：（i）人工觀測的紙質(zhì)記錄，（ii）對于設(shè)備，由簡單設(shè)備或復(fù)雜的高度可配置計算機系統(tǒng)產(chǎn)生的圖譜。數(shù)據(jù)完整性的內(nèi)在風險程度會有所不同，這取決于數(shù)據(jù)（或系統(tǒng)生成、使用數(shù)據(jù)）的可配置程度， 即被潛在處理的可能性（見圖1）。Figure 1: Diagram to illustrate the spectrum of simple machine (left) to complex computerized system (right), and relevance of printo

13、uts as original data圖1：圖示說明簡單設(shè)備圖譜（左）到復(fù)雜的計算機系統(tǒng)圖譜（右），及將打印數(shù)據(jù)作為“初始數(shù)據(jù)”的對應(yīng)關(guān)系With reference to figure 1 above, simple systems (such as pH meters and balances) may only require calibration, whereas complex systems require validation for intended purpose. Validation effort increases from left to right in the

14、 diagram above. However, it is common for companies to overlook systems of apparent lower complexity. Within these systems it may be possible to manipulate data or repeat testing to achieve a desired outcome with limited opportunity of detection (e.g. stand-alone systems with a user configurable out

15、put such as FT-IR, UV spectrophotometers).參考圖1，簡單系統(tǒng)（諸如pH 計和天平）可能只需要校準，而復(fù)雜的系統(tǒng)需要“對預(yù)期用途進行驗證”。驗證活動在上圖中從左到右相應(yīng)加強。但是，企業(yè)常常容易忽視一些貌似并不復(fù)雜的系統(tǒng)。在此類系統(tǒng)中，有可能通過處理數(shù)據(jù)或重復(fù)檢測以獲取期望的結(jié)果，并且不容易被發(fā)現(xiàn)（例如帶有用戶可配置輸出功能單機版設(shè)備，如FT-IR，UV 分光光度計）。Designing systems to assure data quality and integrity系統(tǒng)化設(shè)計以確保數(shù)據(jù)質(zhì)量和完整性Systems should be designe

16、d in a way that encourages compliance with the principles of data integrity.Examples include:系統(tǒng)的設(shè)計應(yīng)遵循數(shù)據(jù)完整性的原則包括以下： Access to clocks for recording timed events 對用作記錄以時間為順序事件的計時器進行權(quán)限控制 Accessibility of batch records at locations where activities take place so that ad hoc datarecording and later transc

17、ription to official records is not necessary 將記錄放置在生產(chǎn)現(xiàn)場，避免不必要的臨時記錄數(shù)據(jù)然后事后謄成正式記錄 Control over blank paper templates for data recording對用于數(shù)據(jù)記錄的紙質(zhì)空白模板進行控制 User access rights which prevent (or audit trail) data amendments用戶權(quán)限控制以防止（或?qū)徲嬜粉櫍?shù)據(jù)篡改 Automated data capture or printers attached to equipment such a

18、s balances采用數(shù)據(jù)自動采集方式或?qū)⒋蛴C連接到設(shè)備，例如天平 Proximity of printers to relevant activities打印機設(shè)置在靠近相關(guān)活動的位置 Access to sampling points (e.g. for water systems)取樣位置所在區(qū)域（例如水系統(tǒng)的取樣位置）的權(quán)限控制 Access to raw data for staff performing data checking activities.對原始數(shù)據(jù)核對的區(qū)域進行權(quán)限控制The use of scribes to record activity on behalf

19、 of another operator should be considered exceptional,and only take place where:用筆錄員替另一個操作人員進行活動記錄是“特例/非常規(guī)流程”，僅在以下情況下采用： The act of recording places the product or activity at risk e.g. documenting line interventions by sterile operators.記錄活動會使產(chǎn)品或行動有風險，例如無菌操作人員記錄生產(chǎn)線的干擾活動 To accommodate cultural or s

20、taff literacy / language limitations, for instance where an activity is performed by an operator, but witnessed and recorded by a Supervisor or Officer.用于解決文化或員工書寫/語言能力不足，例如由主管或辦公室人員見證并記錄。In both situations, the supervisory recording must be contemporaneous with the task being performed,and must ide

21、ntify both the person performing the observed task and the person completing the record.The person performing the observed task should countersign the record wherever possible, although it is accepted that this countersigning step will be retrospective. The process for supervisory (scribe) documenta

22、tion completion should be described in an approved procedure, which should also specify the activities to which the process applies.在這兩種情況下，監(jiān)督記錄必須與正在執(zhí)行的操作任務(wù)同時完成，并對執(zhí)行任務(wù)和完成記錄的兩人進行明確識別。雖然大家都接受回顧性會簽，操作任務(wù)執(zhí)行者仍然需要盡可能及時會簽記錄。應(yīng)在批準的規(guī)程中規(guī)定用監(jiān)督（筆錄）方式完成記錄的流程，并明確指明該流程的適用范圍。Term 術(shù)語Definition 定義Expectation / guidance

23、(where relevant) 要求/指導(dǎo)原則Data 數(shù)據(jù)Information derived or obtained from raw data由初始數(shù)據(jù)衍生或取得的信息(e.g. a reported analytical result 例如報告的分析結(jié)果)Data must be:數(shù)據(jù)必須符合以下原則：A - attributable to the person generating the data 明確數(shù)據(jù)由誰生成L legible and permanent 清晰并持久C contemporaneous 同步記錄O original (or true copy)初始的（或正確

24、的復(fù)制）A accurate 準確性Raw data 原始數(shù)據(jù)Original records and documentation, retained in the formatin which they were originally generated (i.e. paper or electronic), or as a true copy. Raw data must be contemporaneously and accurately recorded by permanent means. In the case of basic electronic equipment whi

25、ch does not store electronic data, or provides only a printeddata output (e.g. balance or pH meter), the printout constitutes the raw data.初始的記錄和文檔，以初始生成的格式或以正確的復(fù)制方式進行留存。 原始數(shù)據(jù)必須是同步和準確的永久記錄。對于一些不保存電子數(shù)據(jù)或僅有數(shù)據(jù)打印輸出的簡單電子設(shè)備 （例如天平或pH 計），打印數(shù)據(jù)視為原始數(shù)據(jù)Raw data must:原始數(shù)據(jù)必須： Be legible and accessible throughout th

26、e data lifecycle.在整個數(shù)據(jù)生命周期過程都清晰可辨并能夠及時獲取 Permit the full reconstruction of the activities resulting in thegeneration of the data允許完全重現(xiàn)數(shù)據(jù)生成的活動In the following definitions, the term data includes raw data.在以下定義中，術(shù)語“數(shù)據(jù)”包括原始數(shù)據(jù)Metadata:元數(shù)據(jù)（屬性數(shù)據(jù)）Metadata is data that describe the attributes of other data,

27、and provide context and meaning. Typically, these are data that describe the structure, data elements, interrelationships and other characteristics of data. It also permits data to be attributable to an individual.元數(shù)據(jù)（屬性數(shù)據(jù)）是解釋其它數(shù)據(jù)的屬性數(shù)據(jù)，并提供背景信息和含義。通常元數(shù)據(jù)（屬性數(shù)據(jù)）用于描述數(shù)據(jù)結(jié)構(gòu)，數(shù)據(jù)要素，內(nèi)在關(guān)系和其它數(shù)據(jù)特征。它也可以用于描述單一數(shù)據(jù)的屬性。

28、Example: data (bold text)例如數(shù)據(jù) （黑體）3.5 and metadata, giving context and meaning, (italic text) are:元數(shù)據(jù)（屬性數(shù)據(jù)）給出了背景和含義，（斜體）sodium chloride batch 1234, 3.5mg. J Smith 01/07/14Metadata forms an integral part of the original record. Without metadata, the data has no meaning.元數(shù)據(jù)（屬性數(shù)據(jù)）與初始記錄密不可分，如果沒有元數(shù)據(jù)，則該數(shù)據(jù)

29、是無意義的。Data Integrity數(shù)據(jù)完整性The extent to which all data are complete, consistent andaccurate throughout the data lifecycle.數(shù)據(jù)完整性的范疇包括數(shù)據(jù)在整個數(shù)據(jù)生命周期過程的完整性，一致性和準確性Data governance數(shù)據(jù)管理The sum total of arrangements to ensure that data,irrespective of the format in which it is generated, is recorded, processed

30、, retained and used to ensure a complete, consistent and accurate record throughout the data lifecycle.指所有約定的總成：不論數(shù)據(jù)的生成格式、記錄方式、處理過程、保留和使用的方式，這些約定確保了整個數(shù)據(jù)生命周期過程中記錄的完整性、一致性和準確性Data governance should address data ownership throughout the lifecycle, and consider the design, operation and monitoring of pr

31、ocesses / systems in order to comply with the principles of data integrity including control over intentional and unintentional changes to information.數(shù)據(jù)管理應(yīng)解決/界定在整個生命周期中數(shù)據(jù)的歸屬問題，并考慮對流程/系統(tǒng)的設(shè)計、運行和監(jiān)控，以便遵循數(shù)據(jù)完整性原則，包括完全控制有意或無意的的信息修改。Data Governance systems should include staff training in the importance of

32、 data integrity principles and the creation of a working environment that encourages an open reporting culture for errors,omissions and aberrant results.數(shù)據(jù)管理體系應(yīng)該包括針對數(shù)據(jù)完整性原則的重要性對員工進行培訓，以及營造鼓勵公開匯報錯誤、數(shù)據(jù)遺漏和結(jié)果異常的文化。Senior management is responsible for the implementation of systems and procedures to minim

33、ise the potential risk to data integrity, and for identifying the residual risk, using the principles of ICH Q9. Contract Givers should perform a similar review as part of their vendor assurance programme運用ICH Q9 風險管理原理，高級管理團隊負責系統(tǒng)和規(guī)程的實施，以降低潛在的數(shù)據(jù)完整性風險，并識別剩余風險。有合同外包的企業(yè)應(yīng)進行類似的審核，以作為供應(yīng)商監(jiān)管項目的一部分。Data Life

34、cycle數(shù)據(jù)生命周期All phases in the life of the data (including raw data) from initial generation and recording through processing (including transformation or migration), use, data retention, archive / retrieval and destruction.數(shù)據(jù)生命周期的的各個階段，包括數(shù)據(jù)的初始生成和記錄、處理（包括轉(zhuǎn)移和整合）、使用、數(shù)據(jù)保存，歸檔/恢復(fù)和銷毀The procedures for destr

35、uction of data should consider data criticality and legislative retention requirements. Archival arrangements should be in place for long term retention (in some cases, periods up to 30 years) for records such as batch documents, marketing authorization application data, traceability data for human-

36、derived starting materials (not an exhaustive list). Additionally, at least 2 years of data must be retrievable in a timely manner for the purposes of trend analysis and inspection.銷毀數(shù)據(jù)的規(guī)程應(yīng)該考慮數(shù)據(jù)的關(guān)鍵性和法規(guī)對保存的要求。對需要長期保留的記錄應(yīng)進行歸檔（在某些情況下，保存期長達30 年），例如批次文件，上市許可申請數(shù)據(jù)，來源于人體的起始原料的可追溯數(shù)據(jù)（非詳盡的清單）。此外，必須能夠及時恢復(fù)至少2 年的

37、數(shù)據(jù)，用于趨勢分析和檢查。Primary Record主記錄The record which takes primacy in cases where data collected or retained concurrently by more than one method fail to concur.當用多于一種方法同步收集或保存的數(shù)據(jù)發(fā)生不一致時，該記錄作為首要判斷依據(jù)。In situations where the same information is recorded concurrently by more than one system, the data owner sh

38、ould define which system generates and retains the primary record, in case of discrepancy. The primary record attribute should be defined in the quality system, and should not be changed on a case by case basis.當相同信息同時被一個以上系統(tǒng)進行記錄時，數(shù)據(jù)擁有者應(yīng)界定由哪個系統(tǒng)生成并保留主記錄，以防數(shù)據(jù)不一致時可以進行判決。“主記錄”屬性應(yīng)在質(zhì)量體系中進行明確定義，并且不得因個例而變化。

39、Original record / True Copy:初始記錄/正確的復(fù)制記錄Original record: Data as the file or format in which it was originally generated, preserving the integrity (accuracy,completeness, content and meaning) of the record, e.g.original paper record of manual observation, or electronic raw data file from a computeri

40、sed systemTrue Copy: An exact copy of an original record, which may be retained in the same or different format in which it was originally generated, e.g. a paper copy of a paper record,an electronic scan of a paper record, or a paper record of electronically generated data初始記錄：數(shù)據(jù)作為文件或以初始生成的格式，維持記錄的

41、完整性（準確性、完全性、有內(nèi)容和有含義）。例如，人工觀測的初始紙張記錄，或計算機系統(tǒng)的初始電子數(shù)據(jù)文件。正確的復(fù)制記錄：與初始記錄完全一致的復(fù)制件，可以與初始生成記錄以相同或不同格式保存。例如紙張記錄的紙質(zhì)復(fù)印件，紙張記錄的電子掃描件，或電子數(shù)據(jù)的紙質(zhì)記錄。Original records must preserve the integrity (accuracy, completeness, content and meaning) of the record. Exact (true) copies of original records may be retained in place

42、of the original record (e.g. scan of a paper record), provided that a documented system is in place to verify and record the integrity of the copy.初始記錄必須維持記錄的完整性（準確性、完全性、有內(nèi)容和含義）。初始記錄完全正確的復(fù)制件可以和初始記錄放置在一起（例如紙質(zhì)記錄的掃描件），并建立文件記錄體系來核對和記錄復(fù)制記錄的完整性It is conceivable for raw data generated by electronic means t

43、o be retained in an acceptable paper or pdf format. However, the data retention process must be shown to include verified copies of all raw data, metadata, relevant audit trail and result files, software / system configuration settings specific to each analytical run*, and all data processing runs (

44、including methods and audit trails) necessary for reconstruction of a given raw data set. It would also require a documented means to verify that the printed records were an accurate representation. This approach is likely to be onerous in its administration to enable a GMP compliant record.對于電子方式生成

45、的原始數(shù)據(jù)可用被接受的紙質(zhì)或PDF 格式進行留存，但是數(shù)據(jù)保存流程必須體現(xiàn)以下各個內(nèi)容：包括核對過的所有原始數(shù)據(jù)、元數(shù)據(jù)（屬性數(shù)據(jù)）、相應(yīng)審計追蹤（系統(tǒng)日志）和結(jié)果文檔，具體到每一個分析測試運行的軟件/系統(tǒng)配置，以及對一套給定原始數(shù)據(jù)進行復(fù)原所必須的所有數(shù)據(jù)處理運行過程（包括方法和審計追蹤/系統(tǒng)日志）。對打印記錄準確性和有效性進行的核對工作需進行記錄。 通過負責任的管理方法，比較容易使記錄符合GMP 要求。* Computerized system configuration settings should be defined,tested and locked as part of com

46、puter system validation. Only those variable settings which relate to an analytical run would be considered as electronic raw data對計算機系統(tǒng)配置參數(shù)設(shè)定應(yīng)作為計算機系統(tǒng)驗證的一部分進行定義，測試和“鎖定“。只有關(guān)于一個分析方法運行的可變設(shè)定參數(shù)才被認作電子原始數(shù)據(jù)。Computer systemtransactions:計算機系統(tǒng)處理A computer system transaction is a single operation or sequence of

47、 operations performed as a single logical unit of work. The operation(s) that make up a transaction are not saved as a permanent record on durable storage until the user commits the transaction through a deliberate act (e.g. pressing a save button).The metadata (i.e., user name, date, and time) is n

48、ot captured in the system audit trail until the user commits the transaction.In Manufacturing Execution Systems (MES), an electronic signature is often required by the system in order for the record to be saved and become permanent.計算機系統(tǒng)的處理是一個單一運作或作為一個單一邏輯“工作單元”完成的一系列運作。這些運作組成了一次處理， 直到用戶通過一個仔細考慮后的操作

49、（例如按下保存鍵）對這個處理認可后， 它們才被作為可以長期存儲的永久記錄保存下來。直到用戶認可了此處理后，元數(shù)據(jù)（屬性數(shù)據(jù)）才被保留在系統(tǒng)的審計追蹤（系統(tǒng)日志）中。在生產(chǎn)執(zhí)行計算機系統(tǒng)MES，系統(tǒng)會定期要求電子簽名來認可記錄，使之成為永久記錄并進行保存。Computer systems should be designed to ensure that the execution of critical operations are recorded contemporaneously by the user and are not combined into a single compute

50、r system transaction with other operations. A critical processing step is a parameter that must be withinan appropriate limit, range, or distribution to ensure the desired product quality. These should be reflected in the process control strategy.計算機系統(tǒng)設(shè)計應(yīng)確保用戶對關(guān)鍵操作進行同步記錄，并且不得與其它操作合并成一個單一的計算機系統(tǒng)處理。關(guān)鍵工藝

51、步驟是指某個參數(shù)必須在合適的限度，范圍，分布之內(nèi)，以確保預(yù)期的產(chǎn)品質(zhì)量。Examples of units of work:“單元操作“的例子Weighing of individual materials 對單個物料的稱量Entry of process critical manufacturing / analytical parameters 數(shù)量生產(chǎn)/分析過程關(guān)鍵參數(shù)Verification of the identity of each component or material that will be used in a batch 用于一批生產(chǎn)中每個部件或物料標識信息的核對Ve

52、rification of the addition of each individual raw material to a batch (e.g. when the sequence of addition is considered critical to process control see figure 2) 對一個初始物料添加過程的核對（例如加料過程的順序?qū)に嚳刂朴嘘P(guān)鍵影響-參見圖表2）Addition of multiple pre-weighed raw materials to bulk vessel when required as a single manufactu

53、ring step (e.g. when the sequence of addition is not considered critical to process control see figure 3)對于多個預(yù)先稱量好的初始物料需要作為一個生產(chǎn)步驟，以完成添加的操作（例如加料順序?qū)に嚳刂茮]有關(guān)鍵影響）Figure 2: Logical design permitting contemporaneous recording of addition of a single material in a manufacturing unit of work. This record is

54、permanently recorded(step2),with audit trail, before progressing to next unit of work.圖 2 是一個邏輯設(shè)計，它允許在一個制造“工作單元”中加入單一物料的同步記錄。在處理下一個“工作單元”之前，這個記錄會被永久記錄（步驟2）并有審計追蹤，允許操作者和復(fù)核者同時記錄物料的添加。Figure 3: Logical design permitting the addition of multiple materials in a manufacturing unit of work before committin

55、g the record to durable media. Steps 1,3 and5 are contemporaneous entries (bar code),but are not permanently recorded with audit trail until圖3 是一個邏輯設(shè)計，在記錄提交給持久介質(zhì)（durable media）前，它允許在一個制造“工作單元”中加入多種物料。步驟1，3，5 是同時輸入的（條形碼），但在步驟6 執(zhí)行前，并沒有被永久性記錄及生成相應(yīng)的審計追蹤。不允許操作者和復(fù)核者同時記錄物料的添加。Audit Trail審計追蹤GMP audit trail

56、s are metadata that are a record of GMP critical information (for example the change or deletion of GMPrelevant data).GMP 審計追蹤是元數(shù)據(jù)（Metadata），記錄了GMP關(guān)鍵信息（例如對于GMP 相關(guān)數(shù)據(jù)的變更和刪除）Where computerized systems are used to capture, process, report or store raw data electronically, system design should always pro

57、vide for the retention of full audit trails to show all changes to the data while retaining previous and original data. It should be possible to associate all changes to data with the persons making those changes, and changes should be time stamped and a reason given. Users should not have the abili

58、ty to amend or switch off the audit trail.當計算機化系統(tǒng)用于電子化采集、處理、報告或儲存原始數(shù)據(jù)時，系統(tǒng)設(shè)計應(yīng)始終提供具有保留全套審計追蹤的功能來體現(xiàn)所有的數(shù)據(jù)更改情況,并保留修改前和初始的數(shù)據(jù)。數(shù)據(jù)的所有改變應(yīng)該可以關(guān)聯(lián)到數(shù)據(jù)修改者，應(yīng)記錄更改的時間并給出原因。用戶應(yīng)該沒有權(quán)限修改或關(guān)閉審計追蹤功能。The relevance of data retained in audit trails should be considered by the company to permit robust data review/ verification. The items included in audit trail should be those of relevance to permit reconstruction of the process or activity. It is not necessary for audit trail review to include every system activity(e.g. user log on/off, keystrokes etc.),and