隨著行業(yè)技術(shù)的發(fā)展進(jìn)步，通常意義的“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)也在發(fā)生著變化，廠家會(huì)設(shè)計(jì)開(kāi)發(fā)更多的功能模塊，儀器變的相對(duì)復(fù)雜和高級(jí)，儀器的使用也會(huì)更加滿足用戶的需求，當(dāng)“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)變的不再那么簡(jiǎn)單，數(shù)據(jù)完整性的控制要求是否也需要相應(yīng)的更新和匹配，還是可以延用之前的簡(jiǎn)單模式管理，本文結(jié)合國(guó)內(nèi)外數(shù)據(jù)完整性相關(guān)指南及法規(guī)要求，探討“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)的數(shù)據(jù)完整性管理，在此與大家討論分享，屬于此類儀器范疇的有pH計(jì)、天平、濾芯完整性測(cè)試儀、塵埃粒子計(jì)數(shù)器等。

       1、數(shù)據(jù)完整性的基本原則：

       The data and records should be ' attributable, legible, contemporaneous, original' and accurate, complete, consistent, enduring, and available; commonly referred to as "ALCOA+".數(shù)據(jù)和記錄應(yīng)‘可歸屬、清晰、同步、原始且準(zhǔn)確、完整、一致、持久和可用；通常被稱為“ALCOA+”。無(wú)論是紙質(zhì)記錄還是電子記錄，無(wú)論是簡(jiǎn)單類計(jì)算機(jī)化系統(tǒng)還是復(fù)雜類計(jì)算機(jī)化系統(tǒng)，在數(shù)據(jù)的生命周期內(nèi)都應(yīng)滿足數(shù)據(jù)完整性的基本要求。

       2、簡(jiǎn)單類計(jì)算機(jī)化系統(tǒng)

       2.1 MHRA ‘GXP’ Data Integrity Guidance and Definitions

       Simple electronic systems with no configurable software and no electronic data retention (e.g. pH meters, balances and thermometers) may only require calibration.

       在MHRA數(shù)據(jù)完整性指南的“建立數(shù)據(jù)關(guān)鍵性和固有可靠性風(fēng)險(xiǎn)”一節(jié)，簡(jiǎn)單的電子系統(tǒng)被定義為：“無(wú)參數(shù)設(shè)置軟件、無(wú)電子數(shù)據(jù)保存功能的電子系統(tǒng)（如pH計(jì)、天平和溫度計(jì)）”。

       2.2 WHO Guideline on data integrity

       11.4. Where electronic instruments (e.g. certain pH meters, balances and thermometers) or systems with no configurable software and no electronic data retention are used, controls should be put in place to prevent the adverse manipulation of data and to prevent repeat testing to achieve the desired result.

       在WHO的數(shù)據(jù)完整性指南的“計(jì)算機(jī)化系統(tǒng)”章節(jié)，簡(jiǎn)單的電子系統(tǒng)同樣被認(rèn)定為沒(méi)有可配置軟件和沒(méi)有電子數(shù)據(jù)保存的系統(tǒng)（如pH計(jì)、天平和溫度計(jì)），這一點(diǎn)在定義上與MHRA完全一致。無(wú)參數(shù)設(shè)置軟件、無(wú)電子數(shù)據(jù)保存功能的簡(jiǎn)單電子系統(tǒng)（如pH計(jì)、天平和溫度計(jì)）

       2.3 PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

       8.9 Direct print-outs from electronic systems

       8.9.1 Some very simple electronic systems, e.g. balances, pH meters or simple processing equipment which do not store data, generate directly-printed paper records.

       PIC/S 良好數(shù)據(jù)完整性管理規(guī)范中的簡(jiǎn)單類系統(tǒng)指直接打印輸出類電子系統(tǒng)：一些非常簡(jiǎn)單的計(jì)算機(jī)化系統(tǒng)例如，天平、酸度計(jì)；或簡(jiǎn)單的處理儀器，不存儲(chǔ)電子數(shù)據(jù)，直接生成打印的紙質(zhì)記錄。

       2.4 PA/PH/OMCL (08) 69 R7 – Validation of Computerized Systems – Core document

       Table I: Categorisation of computerised systems (based on Reference 6)

       簡(jiǎn)單類計(jì)算機(jī)化系統(tǒng)：簡(jiǎn)單的軟件、有限的用戶配置，例如：酸度計(jì)、天平、UV-VIS、自動(dòng)旋光儀、天平、TLC分析儀等。(備注：復(fù)雜系統(tǒng)的UV/VIS指色譜系統(tǒng)配套的檢測(cè)系統(tǒng))

       總結(jié)：按照以上業(yè)界比較認(rèn)可的典型的數(shù)據(jù)完整性指南，簡(jiǎn)單類的計(jì)算機(jī)化系統(tǒng)通常被定義為無(wú)參數(shù)設(shè)置或有限的用戶配置軟件、無(wú)電子數(shù)據(jù)保存功能、僅能直接打印的計(jì)算機(jī)化系統(tǒng)。OMCL中計(jì)算機(jī)化系統(tǒng)的分類中，將計(jì)算機(jī)化系統(tǒng)按照復(fù)雜程度和用戶可配置程度進(jìn)行了分類，其中簡(jiǎn)單類計(jì)算機(jī)化系統(tǒng)涵蓋了直接打印輸出的電子系統(tǒng)及具備電子數(shù)據(jù)存儲(chǔ)的計(jì)算機(jī)化系統(tǒng)。

       3、“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)數(shù)據(jù)完整性控制點(diǎn)及風(fēng)險(xiǎn)點(diǎn)

       3.1 WHO Guideline on data integrity

       11.4. Where electronic instruments (e.g. certain pH meters, balances and thermometers) or systems with no configurable software and no electronic data retention is used, controls should be put in place to prevent the adverse manipulation of data and to prevent repeat testing to achieve the desired result.

       對(duì)于簡(jiǎn)單類計(jì)算機(jī)化系統(tǒng)，應(yīng)該采取控制措施防止數(shù)據(jù)被篡改，防止為了得到想要的結(jié)果而重復(fù)測(cè)試。

       3.2 PIC/S GOOD PRACTICES FOR DATA MANAGEMENT AND INTEGRITY IN REGULATED GMP/GDP ENVIRONMENTS

       As a minimum, simple systems should have normal and admin users, but complex systems will typically require more levels of users (e.g. a hierarchy) to effectively support access control.

       對(duì)于簡(jiǎn)單的系統(tǒng)，至少有普通及管理員賬戶，對(duì)于較復(fù)雜的系統(tǒng)需要更多的賬戶等級(jí)支持用戶登錄管理。

       It is acknowledged that some very simple systems lack appropriate audit trails; however, alternative arrangements to verify the veracity of data should be implemented, e.g. administrative procedures, secondary checks and controls.

       通常來(lái)說(shuō)，大家比較公認(rèn)的，對(duì)于一些簡(jiǎn)單的計(jì)算機(jī)化系統(tǒng)缺少相應(yīng)的審計(jì)追蹤，這種情況，應(yīng)采取相應(yīng)的替代的措施來(lái)實(shí)施核對(duì)數(shù)據(jù)的真實(shí)性，例如，管理性的文件，第二人的復(fù)核等控制措施。

       3.3 APIC Practical risk-based guide for managing Data Integrity

       對(duì)于直接打印輸出無(wú)電子數(shù)據(jù)存儲(chǔ)的計(jì)算機(jī)化系統(tǒng)，按照APIC的系統(tǒng)分類，應(yīng)屬于第三類：

       Category 3: An electronic system with some limited manual adjustable input data and the generated CGxP data is not stored but printed out. Typical examples could be potentiometric titrators not connected to a PC, balances with printer.

       第三類系統(tǒng)的建議控制要求如下（以嚴(yán)重性高為例）：

       1、良好的記錄管理：記錄受控發(fā)放回收及平衡、相關(guān)GXP信息打印完整

       2、外圍記錄：儀器使用的追溯性。

       3、權(quán)限管理：時(shí)間日期鎖定。

       4、記錄歸檔保存（紙質(zhì)記錄）。

       備注：對(duì)于僅能人工觀察，但是可以配備打印功能的計(jì)算機(jī)化系統(tǒng)，比如很多稱量系統(tǒng)，目前更多的監(jiān)管要求必須配備打印功能，升級(jí)變?yōu)锳PIC的三類系統(tǒng)。

       4、“簡(jiǎn)單”類計(jì)算機(jī)系統(tǒng)的多變性

       隨著行業(yè)技術(shù)的發(fā)展進(jìn)步，通常意義的“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)也在發(fā)生著變化，廠家會(huì)設(shè)計(jì)開(kāi)發(fā)更多的功能模塊，儀器變的相對(duì)復(fù)雜和高級(jí)，儀器的使用也會(huì)更加滿足用戶的需求。

       4.1 系統(tǒng)對(duì)接至其它系統(tǒng)

       以嚴(yán)重程度較高的用于放行測(cè)試儀器為例，該儀器為直接打印輸出無(wú)電子數(shù)據(jù)存儲(chǔ)的計(jì)算機(jī)化系統(tǒng)，但可經(jīng)過(guò)接口將數(shù)據(jù)傳輸至另一個(gè)系統(tǒng)，用戶配置開(kāi)發(fā)后，將該儀器組態(tài)并入LIMS系統(tǒng)，該儀器按照APIC分類表，則劃為第四類儀器：

       Category 4: An electronic system with some limited manual adjustable input data and the generated CGxP data is not stored but sent via an interface to another system, e.g., a cat 5 or 6. Typical examples could be temperature sensors

       以嚴(yán)重程度較高的用于放行測(cè)試的儀器為例，該儀器為直接打印輸出無(wú)電子數(shù)據(jù)存儲(chǔ)的計(jì)算機(jī)化系統(tǒng)，對(duì)于第四類計(jì)算機(jī)化系統(tǒng)建議的要求：

       ● 良好的記錄管理：記錄受控發(fā)放回收及平衡。

       ● 接口驗(yàn)證：確認(rèn)數(shù)據(jù)傳輸對(duì)接功能。

       ● 權(quán)限管理：需用戶權(quán)限管理，至少兩級(jí)權(quán)限，管理員及普通用戶

       ● 記錄歸檔保存（按照LIMS數(shù)據(jù)文件管理）

       4.2 系統(tǒng)具備電子數(shù)據(jù)存儲(chǔ)

       隨著行業(yè)技術(shù)的發(fā)展進(jìn)步，通常意義的“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)也在發(fā)生著變化，廠家會(huì)設(shè)計(jì)開(kāi)發(fā)更多的功能模塊，例如，增加了電子數(shù)據(jù)存儲(chǔ)功能，該儀器按照APIC分類表，則劃為第五類儀器：

       Category 5: An electronic system where CGxP data are permanently stored, and these CGxP data are not modified by the user to generate results (static CGxP data). Examples could include UV instruments or IR instruments used for identification testing, in line particle size and TOC testing

       以嚴(yán)重程度較高的用于放行測(cè)試的儀器為例，該儀器具備電子數(shù)據(jù)存儲(chǔ)功能，對(duì)于第五類計(jì)算機(jī)化系統(tǒng)建議的最低要求：

       ● 良好的記錄管理：記錄受控發(fā)放回收及平衡。

       ● 登錄控制：?jiǎn)⒂谩?/p>

       ● 權(quán)限管理：需用戶權(quán)限管理，至少兩級(jí)權(quán)限，管理員及普通用戶。

       ● 審計(jì)追蹤：系統(tǒng)審計(jì)追蹤。

       ● 數(shù)據(jù)備份：每天進(jìn)行備份。

       4.3 相關(guān)法規(guī)定

       MHRA 數(shù)據(jù)完整性指南中對(duì)于此類特殊儀器也進(jìn)行了相關(guān)規(guī)定如下：

       Where the basic electronic equipment does store electronic data permanently and only holds a certain volume before overwriting; this data should be periodically reviewed and where necessary reconciled against paper records and extracted as electronic data where this is supported by the equipment itself.

       如果基本電子設(shè)備不存儲(chǔ)電子數(shù)據(jù)，或僅提供打印的數(shù)據(jù)輸出（例如，天平或pH計(jì)），則打印件構(gòu)成原始數(shù)據(jù)。如果基本電子設(shè)備能存儲(chǔ)電子數(shù)據(jù)，但只保存一定量，然后就會(huì)被寫(xiě)滿覆蓋，則應(yīng)定期對(duì)此數(shù)據(jù)進(jìn)行審核，必要時(shí)與紙質(zhì)記錄進(jìn)行數(shù)量平衡，如果設(shè)備本身支持時(shí)還應(yīng)作為電子數(shù)據(jù)提取出來(lái)。

       5、不再簡(jiǎn)單的“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)是否可以簡(jiǎn)單化管理？

       當(dāng)簡(jiǎn)單類的計(jì)算機(jī)化系統(tǒng)更新升級(jí)后具備電子數(shù)據(jù)存儲(chǔ)功能，是否可以不啟用這些功能，仍然按照打印數(shù)據(jù)作為原始數(shù)據(jù)進(jìn)行管理？

       ● 實(shí)例1：2023年 FDA審計(jì)印度某公司的部分483缺陷，里邊提到了具備電子數(shù)據(jù)存儲(chǔ)功能的儀器未開(kāi)啟，以打印數(shù)據(jù)作為原始數(shù)據(jù)管理，對(duì)于儀器中的電子數(shù)據(jù)未進(jìn)行審核備份等。

       Your firm operates(b)(4) filter integrity test equipment in support of general and (b)(4) parenteral manufacturing operations. During our review of the (b)(4) equipment and software, it was observed that the firm was not aware of the equipment data storage capability and consequently does not review or backup the electronic data generated and stored on the equipment, only using printer printouts as primary data. Per your firm's management, the data capability storage for this equipment is up to 200 tests, after which the data is overwritten with the most recent data.

       你們公司使用的過(guò)濾器完整性測(cè)試儀，用于注射劑的生產(chǎn)操作。在我們對(duì)設(shè)備和軟件的審查中，發(fā)現(xiàn)貴公司沒(méi)有意識(shí)到設(shè)備的數(shù)據(jù)存儲(chǔ)能力，因此沒(méi)有審核或備份設(shè)備上產(chǎn)生和存儲(chǔ)的電子數(shù)據(jù)，只使用打印的數(shù)據(jù)作為原始數(shù)據(jù)。據(jù)貴公司的管理人員稱，該設(shè)備的數(shù)據(jù)容量存儲(chǔ)最多可達(dá)200條測(cè)試數(shù)據(jù)，達(dá)到200條數(shù)據(jù)后，后續(xù)的數(shù)據(jù)將被最新的數(shù)據(jù)覆蓋。

       ● 實(shí)例2：2024 FDA審計(jì)印度另一家公司的483報(bào)告中同樣指出了具備電子數(shù)據(jù)存儲(chǔ)和備份功能的儀器，功能未啟用，使用打印的數(shù)據(jù)作為原始數(shù)據(jù)，并且打印條的時(shí)間日期倒簽等問(wèn)題被發(fā)現(xiàn)。

       OBSERVATION 7

       There are no controls to prevent operators from changing the date and time on the Climet nonviable particle count equipment. Operators stated they had changed the date and time to back date printouts. Additionally, the instIUillent is capable of storing and backing-up electronic data, but the function is not used.

       The Oxi 73 10 Dissolved Oxygen Meter allows automatic saving of electronic data that can be backed up to a USB or transfe1Ted through a connected computer, but these capabilities are not being used.

       沒(méi)有相應(yīng)的控制措施來(lái)防止塵埃粒子計(jì)數(shù)器更改日期和時(shí)間，分析員承認(rèn)更改了日期和時(shí)間，并對(duì)打印條進(jìn)行倒簽；另外，該儀器具備電子數(shù)據(jù)存儲(chǔ)和電子數(shù)據(jù)數(shù)據(jù)備份功能，未啟用；Oxi 73 10 Dissolved Oxygen Meter可以實(shí)現(xiàn)自動(dòng)存儲(chǔ)電子數(shù)據(jù)，數(shù)據(jù)可以通過(guò)USB或傳輸?shù)诫娔X，這些功能未啟用。

       ● 實(shí)例3：在近期國(guó)內(nèi)某藥廠的FDA審計(jì)483報(bào)中，同樣是對(duì)于此類儀器的電子數(shù)據(jù)的管理提出了相關(guān)問(wèn)題。

       A)Your firm operate (b)(4) portable non-viable particle monitoring equipment used to perform and generated test data for non-viable particle (NVP) count used in environment monitoring /cleanroom qualification activities in Grade Band Grade C areas in support of general (b)(4) parenteral manufacturing operations. (b)(4) equipment have no time stamped audit trail, data management, alarm management, and archival and retrieval of records capabilities.

       貴公司使用(b)(4)型懸浮粒子計(jì)數(shù)器為B級(jí)和C級(jí)潔凈區(qū)的環(huán)境監(jiān)測(cè)/潔凈區(qū)確認(rèn)中的懸浮粒子項(xiàng)目提供檢測(cè)數(shù)據(jù)。這個(gè)儀器的審計(jì)追蹤、數(shù)據(jù)管理、報(bào)警管理、數(shù)據(jù)歸檔、數(shù)據(jù)調(diào)閱活動(dòng)均無(wú)時(shí)間戳證明。

       B) Your firm operates(b)(4) integrity test equipment and integrity equipment use in support of general (b)(4) parenteral manufacturing operations. The mentioned equipment does not have time stamped audit trail, data management, alarm management, and archival and retrieval of records capabilities.

       貴公司使用(b)(4)型完整性測(cè)試儀和(b)(4)型完整性儀，為仿制藥(b)(4)注射劑的生產(chǎn)操作提供支持。這個(gè)儀器無(wú)時(shí)間戳的審計(jì)追蹤，無(wú)數(shù)據(jù)管理、報(bào)警管理、數(shù)據(jù)歸檔、還原功能。

       綜上三封FDA483報(bào)告，對(duì)于簡(jiǎn)單類的計(jì)算機(jī)化系統(tǒng)更新升級(jí)后具備電子數(shù)據(jù)存儲(chǔ)功能，監(jiān)管機(jī)構(gòu)要求應(yīng)啟用這些功能，實(shí)現(xiàn)更好的數(shù)據(jù)管理，因?yàn)檫@些功能啟用會(huì)帶來(lái)更好的數(shù)據(jù)安全，數(shù)據(jù)的可追溯性更強(qiáng)，能夠更好的防止數(shù)據(jù)被篡改，防止為了得到想要的結(jié)果而重復(fù)測(cè)試。

       同時(shí)在MHRA的數(shù)據(jù)完整性指南中也明確指出了：企業(yè)應(yīng)啟用滿足當(dāng)前法規(guī)期望的相關(guān)系統(tǒng)，對(duì)于系統(tǒng)進(jìn)行相應(yīng)的升級(jí)更新配備相應(yīng)的功能。

       It is expected that companies should be implementing systems that comply with current regulatory expectations2

       2 It is expected that GMP facilities with industrial automation and control equipment/ systems such as programmable logic controllers should be able to demonstrate working towards system upgrades with individual login and audit trails (reference: Art 23 of Directive 2001/83/EC).

       6、“簡(jiǎn)單”類計(jì)算機(jī)系統(tǒng)風(fēng)險(xiǎn)及控制措施

       表格取自ISPE data integrity by design 12 Appendix D2 – Instrument Devices with

       Electronic Record Storage，對(duì)于缺少賬戶管理、審計(jì)追蹤、數(shù)據(jù)備份等相關(guān)問(wèn)題，ISPE指南給出了中期控制措施及長(zhǎng)遠(yuǎn)的控制措施。

       對(duì)于沒(méi)有審計(jì)追蹤功能的儀器如何處理，在數(shù)據(jù)完整性的法規(guī)中也有明確的規(guī)定，具體如下

       ● MHRA ‘GXP’ Data Integrity Guidance and Definitions

       Where relevant audit trail functionality does not exist (e.g. within legacy systems) an alternative control may be achieved for example defining the process in an SOP, and use of log books. Alternative controls should be proven to be effective.

       Where add-on software or a compliant system does not currently exist, continued use of the legacy system may be justified by documented evidence that a compliant solution is being sought and that mitigation measures temporarily support the continued use.

       如果沒(méi)有相關(guān)的審計(jì)追蹤功能（例如，歷史遺留系統(tǒng)內(nèi)），可以采用替代的控制來(lái)達(dá)成目的，如在一個(gè)SOP中規(guī)定該過(guò)程，使用日志本。應(yīng)證明替代控制是有效的。如果目前沒(méi)有軟件插件或合規(guī)系統(tǒng)，可以通過(guò)書(shū)面證據(jù)來(lái)論證繼續(xù)使用老系統(tǒng)，證明正在尋求合規(guī)的解決方案，而風(fēng)險(xiǎn)緩解措施暫時(shí)支持繼續(xù)使用。

       ● PICS Good Practices for Data Management and Integrity in Regulated GMP-GDP Environments

       Audit trail Expectation

       Consideration should be given to data management and integrity requirements when purchasing and implementing computerized systems. Companies should select software that includes appropriate electronic audit trail functionality.

       Companies should endeavor to purchase and upgrade older systems to implement software that includes electronic audit trail functionality.

       It is acknowledged that some very simple systems lack appropriate audit trails; however, alternative arrangements to verify the veracity of data should be implemented, e.g. administrative procedures, secondary checks and controls. Additional guidance may be found under section 9.10 regarding hybrid systems.

       Potential risk of not meeting expectations/items to be checked

       If no electronic audit trail system exists a paper based record to demonstrate changes to data may be acceptable until a fully audit trailed (integrated system or independent audit software using a validated interface) system becomes available.

       在采購(gòu)和使用計(jì)算機(jī)化系統(tǒng)時(shí)，應(yīng)考慮數(shù)據(jù)管理和數(shù)據(jù)可靠性要求。公司應(yīng)選擇包含適當(dāng)?shù)碾娮訉徲?jì)追蹤功能的軟件。公司應(yīng)盡力采購(gòu)及升級(jí)舊系統(tǒng)，從而能夠運(yùn)行具有電子審計(jì)追蹤功能的軟件。眾所周知，一些非常簡(jiǎn)單的系統(tǒng)缺乏適當(dāng)?shù)膶徲?jì)追蹤。但是，應(yīng)采用其他方式核實(shí)數(shù)據(jù)真實(shí)性，例如：管理性程序，二次復(fù)核和控制。如果沒(méi)有電子審計(jì)追蹤系統(tǒng)，可以使用能夠證明數(shù)據(jù)更改的紙質(zhì)記錄，直至審計(jì)追蹤系統(tǒng)（集成系統(tǒng)或使用經(jīng)驗(yàn)證的界面的獨(dú)立審計(jì)軟件）可用。

       ● WHO Guideline on data integrity

       11.12. Where a system cannot support ALCOA+ principles by design (e.g. legacy systems with no audit trail), mitigation measures should be taken for defined temporary periods. For example, add-on software or paper based controls may be used. The suitability of alternative systems should be justified and documented. This should be addressed within defined timelines.

       11.12.如果系統(tǒng)設(shè)計(jì)無(wú)法支持ALCOA +原則（例如，沒(méi)有審計(jì)追蹤的遺留系統(tǒng)），應(yīng)在規(guī)定的臨時(shí)期間采取緩解措施。例如，可以使用附加軟件或紙質(zhì)化控制。替代系統(tǒng)的適用性應(yīng)經(jīng)過(guò)論證并用文件記錄。應(yīng)在規(guī)定時(shí)限內(nèi)解決。‘’

       7. 總結(jié)分析

       隨著行業(yè)技術(shù)的發(fā)展進(jìn)步，通常意義的“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)也在發(fā)生著變化，廠家會(huì)設(shè)計(jì)開(kāi)發(fā)更多的功能模塊，儀器變的相對(duì)復(fù)雜和高級(jí)，儀器的使用也會(huì)更加滿足用戶的需求，當(dāng)“簡(jiǎn)單”類計(jì)算機(jī)化系統(tǒng)變的不再那么簡(jiǎn)單，數(shù)據(jù)完整性的控制策略也需要相應(yīng)的更新和匹配，延用之前的簡(jiǎn)單模式管理存在極大的合規(guī)性風(fēng)險(xiǎn)，這些功能啟用會(huì)帶來(lái)更好的數(shù)據(jù)安全，數(shù)據(jù)的可追溯性更強(qiáng)，能夠更好的防止數(shù)據(jù)被篡改，防止為了得到想要的結(jié)果而重復(fù)測(cè)試，同時(shí)對(duì)于較老的歷史遺留系統(tǒng)，數(shù)據(jù)完整性的相關(guān)風(fēng)險(xiǎn)應(yīng)進(jìn)行識(shí)別，應(yīng)給出中期控制措施(使用附加軟件或紙質(zhì)化控制等)及長(zhǎng)遠(yuǎn)的控制措施，在采購(gòu)和使用計(jì)算機(jī)化系統(tǒng)時(shí)，應(yīng)考慮數(shù)據(jù)管理和數(shù)據(jù)可靠性要求，公司應(yīng)選擇包含適當(dāng)?shù)碾娮訉徲?jì)追蹤功能的軟件。