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          1. 歡迎光臨~合肥希合機械科技有限公司
            語言選擇: 中文版 ∷  英文版



            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.


            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.


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


            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.


            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:


            • 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.


            • 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.


            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.


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


            • 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.


            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。


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


            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



            • 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.


            • 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.


            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.


            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.




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