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EMA數據完整性問答

1. How can data risk be assessed?

1. 如何評估數據風險?


Data risk assessment should consider the vulnerability of data toinvoluntary or deliberate amendment, deletion or recreation. Control measureswhich prevent unauthorised activity and increase visibility / detectability canbe used as risk mitigating actions.

數據風險評估應考慮無意或有意修改、刪除或重建數據導致的隱患。可通過實施預防未授權活動的控制措施,以及增加可見性/可檢測性來減少風險。


Examples of factors which can increase risk of data integrity failureinclude complex, inconsistent processes with open-ended and subjectiveoutcomes. Simple tasks which are consistent, well-defined and objective lead toreduced risk.

導致增加數據完整性風險的例子包括:結果開放主觀的復雜且不一致的過程。一致、定義明確并且客觀的簡單任務風險較小。


Risk assessment should include a business process focus (e.g. production,QC) and not just consider IT system functionality or complexity. Factors toconsider include:

風險評估應包括對業務(例如生產、QC)的關注,不能僅考慮IT系統的功能或復雜性。應考慮的因素包括:


Proces scomplexity 工藝復雜性


  • Process consistency, degree of automation/human interface

  • 工藝一致性,自動化程度/人性化界面


  • Subjectivity of outcome / result

  • 結果的客觀性


  • Is the process open-ended or well defined

  • 工藝結果是否開放或定義是否明確


This ensures that manual interfaces with IT systems are considered in therisk assessment process. Computerised system validation in isolation may notresult in low data integrity risk, in particular when the user is able toinfluence the reporting of data from the validated system.

在風險評估過程中,這將確保考慮人機(IT系統)界面的因素。對計算機化系統的獨立驗證并不會導致數據完整性的低風險,尤其當使用者能夠影響驗證系統中數據的報告時。


2. How can data criticality be assessed?

2. 如何評估數據的重要性?


The decision which data influences may differ in importance, and the impactof the data to a decision may also vary. Points to consider regarding datacriticality include:

數據影響決策的重要性可能不同,數據對一個決策產生的影響也各種各樣。考慮數據重要性的關鍵包括:


  • What decisiondoes the data influence?

  • 數據能影響哪些決策?


For example: when making a batch release decision, data which determinescompliance with critical quality attributes is of greater importance thanwarehouse cleaning records.

例如:當做批次放行的決策時,決定關鍵質量屬性合規的數據比倉庫清潔記錄的數據重要。


  • What is theimpact of the data to product quality or safety?

  • 數據對產品質量或安全性的影響有哪些?


For example: for an oral tablet, active substance assay data is of greaterimpact to product quality and safety than tablet dimensions’ data.

例如:對于口服片劑,活性成分化驗數據對藥品質量和安全性的影響比片劑分散性數據的影響更為重要。


3. What does ‘Data Lifecycle’ refer to?

3. “數據生命周期”是指?


‘Data lifecycle’ refers to how data is generated, processed, reported,checked, used for decision-making, stored and finally discarded at the end ofthe retention period.

“數據生命周期”是指數據從產生、加工、報告、檢查、用于制定決策、存儲到最終在保存期結束時的銷毀。


Data relating to a product or process may cross various boundaries withinthe lifecycle, for example:

涉及產品和工藝的數據可能在生命周期中跨越多個階段,例如:


  • IT systems

  • IT系統


  • Quality system applications

  • 質量體系程序


  • Production

  • 生產


  • Analytical

  • 分析


  • Stockmanagement systems

  • 存儲管理體系


  • Datastorage (back-up and archival)

  • 數據存儲(備份和存檔)


  • Organisational

  • 組織


  • Internal(e.g. between production, QC and QA)

  • 內部(例如,在生產、QC和QA之間)


  • External(e.g. between contract givers and acceptors)

  • 外部(例如在委托方和受托方之間)


  • Cloud-basedapplications and storage

  • 基于云的程序和存儲


4. Why is ‘Data lifecycle’ management important to ensureeffective data integrity measures?

4. 為何“數據生命周期”管理對確保數據完整性措施有效很重要?


Data integrity can be affected at any stage in the lifecycle. It istherefore important to understand the lifecycle elements for each type of dataor record, and ensure controls which are proportionate to data criticality andrisk at all stages.

數據生命周期任何階段都可影響數據完整性。因此,理解每種類型的數據或記錄的生命周期元素,并確保根據各階段數據的重要性和風險程度進行控制很重要。


5. What should be considered when reviewing the ‘Datalifecycle’?

5. 在審查“數據生命周期”時應考慮什么?


  • The ‘Data lifecycle’ refers to the:

  • “數據生命周期”指的是:


  • Generation and recording of data

  • 數據的產生和記錄


  • Processing into usable information

  • 處理成可用信息


  • Checking the completeness and accuracy ofreported data and processed information

  • 檢查報告數據和已處理信息的完整性和準確性


  • Data (or results) are used to make a decision

  • 使用數據(或結果)來制定決策


  • Retaining and retrieval of data whichprotects it from loss or unauthorised amendment

  • 數據的保留和回復,避免數據丟失或避免未經授權對數據進行修改


  • Retiring or disposal of data in a controlledmanner at the end of its life

  • 在數據生命周期末尾以受控的方式對數據進行停用或處置


‘Data Lifecycle’ reviews are applicable to both paper andelectronic records, although control measures may be applied differently. Inthe case of computerised systems, the ’data lifecycle’ review should beperformed by business process owners (e.g. production, QC) in collaborationwith IT personnel who understand the system architecture. The description ofcomputerised systems required by EU GMP Annex 11 paragraph 4.3 can assist thisreview. The application of critical thinking skills is important to not onlyidentify gaps in data governance, but to also challenge the effectiveness ofthe procedural and systematic controls in place.

Segregation of duties between data lifecycle stagesprovides safeguards against data integrity failure by reducing the opportunityfor an individual to alter, mis-represent or falsify data without detection.

盡管控制措施可能有所不同,審查“數據生命周期”對紙質記錄和電子記錄同樣適用。在計算機化系統實例中,應該由業務負責人(例如生產人員、QC)與理解系統架構的IT人員聯合對“數據生命周期”進行審查。EU GMP附件11中4.3段里對計算機化系統要求的描述可有助于審查。關鍵思維技術的應用不僅對于數據管理中識別差距很重要,而且對于保證流程有效性和合理控制系統提出了挑戰。

在數據生命周期中,隔離的任務能通過減少在未檢測狀態下進行個人改變、誤傳或偽造數據的機會減少數據完整性問題的風險。


Data risk should be considered at each stage of the datalifecycle review.

在數據生命周期審查各階段都應考慮數據的風險。


6. ‘Data lifecycle’: What risks should be considered whenassessing the generating and recording of data?

6. “數據生命周期”:在評估產生和記錄數據時應考慮什么風險?


The following aspects should be considered when determining risk andcontrol

measures:

在確定風險和控制措施時應考慮以下因素:


  • How and where is original data created (i.e.paper or electronic)

  • 原始數據如何產生?在何處產生?(例如紙質還是電子版)


  • What metadata is associated with the data, toensure a complete, accurate and traceable record, taking into account ALCOAprinciples. Does the record permit the reconstruction of the activity

  • 元數據與數據進行關聯,如何確保按照ALCOA原則保證記錄的完整性、準確性和可追溯性。記錄是否會限制活動的重建。


  • Where is the data and metadata located

  • 數據和元數據存放在哪里?


  • Does the system require that data is saved to permanentmemory at the time of recording, or is it held in a temporary buffer

  • 系統是否要求記錄時按照永久性方式存儲數據,還是臨時性存儲?


In the case of some computerised analytical andmanufacturing equipment, data may be stored as a temporary local file prior totransfer to a permanent storage location (e.g. server). During the period of‘temporary’ storage, there is often limited audit trail provision amending,deleting or recreating data. This is a data integrity risk. Removing the use oftemporary memory (or reducing the time period that data is stored in temporarymemory) reduces the risk of undetected data manipulation.

在一些計算機分析和生產設備的案例中,數據可能有限存儲在當地臨時文件中,之后轉移到永久存儲地點(例如:服務器)。在“臨時”存儲期間,審計追蹤關于修改、刪除或重建數據規定受限。這是數據完整性風險。停止使用臨時存儲(或減少數據臨時存儲的時間)將減少未檢測狀態下操作數據的風險。


  • Is itpossible to recreate, amend or delete original data and metadata;

  • 是否有可能對原始數據和元數據進行重建、修改或刪除?


Controls over paper records are discussed elsewhere inthis guidance.

指南中每處都討論了對紙質記錄的控制。


Computerised system controls may be more complex,including setting of user privileges and system configuration to limit orprevent access to amend data. It is important to review all data accessopportunities, including IT helpdesk staff, who may make changes at the requestof the data user. These changes should be procedurally controlled, visible andapproved within the quality system.

計算機化系統控制可能更為復雜,包括使用者權限的設置,以及限制或阻止修改數據的系統設置。審查所有接觸數據的機會很重要,包括IT技術支持維護員工,該員工可能按照數據使用者的要求改動數據。這些改動應該程序受控、可視化,并且在質量體系中得到批準。


How data istransferred to other locations or systems for processing or storage;

Data should be protected from possibility of intentionalor unintentional loss or amendment during transfer to other systems (e.g. forprocessing, review or storage). Paper records should be protected fromamendment, or substitution. Electronic interfaces should be validated todemonstrate security and no corruption of data, particularly where systemsrequire an interface to present data in a different structure or file format.

如何轉移數據到其他地方或系統以進行處理或存儲;在轉移到其他系統過程中(例如出于處理、審查或存儲的目的),應避免有意或無意丟失或修改數據的可能性。應避免修改或替換紙質文件。應對電子界面進行驗證,證明數據安全無破壞,尤其當系統要求以不同結構或文件格式顯示數據時。


來源:藥研

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