确定了关键数据和非关键数据后，根据GMP附录 计算机化系统制定数据备份与恢复操作规程，定期对数据进行备份、安全储存，制定合理的储存时限，并进行验证（如灾难恢复等）。

主要去看数据可靠性相关的指南和法规要求，这方面的资料是非常多的。

但是好像并没有对“关键数据”进行明确的定义。通常GMP数据高于非GMP，关键环节的GMP数据高于非关键环节的GMP数据。关键系统产品的数据高于非关键系统产生的数据。

至于怎么维护，就是确保关键数据在整个生命周期内都被确定和保护，被合理的使用和管理。

供参考。

首先GMP-关键数据和非关键数据都应该满足数据完整性的基本要求，在数据生命周期内满足ALCOA+的原则，可依据数据的关键程度采用风险评估的策略制定不同的管理策略，例如数据的审核策略、数据的备份策略、审计检查策略等，例如：制剂的无菌检测项目，对于最终结果的判定需要第二人审核；对于放行相关数据需要放行前审核；对于放行相关数据的仪器系统引入在线备份系统等。相关的法规好指南建议采用识林的关键词搜索：数据完整性，另外API CPractical Risk-based Guide for Managing Data Integrity和 PDA80 有具体的风险管控案例供参考。

• 对GMP数据关键程度进行风险评估，基于风险制定不同的策略（数据对相关决策的影响及病人用药风险）

EMA GMP Data Integrity Questions and Answers

How can data criticality be assessed? 

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

What decision does the data influence?

For example: when making a batch release decision, data which determines compliance with critical quality attributes is of greater importance than warehouse cleaning records.

What is the impact of the data to product quality or safety?

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

PIC/S Good Practices for Data Management and Integrity in Regulated GMP/GDP Environments

5.4 Data criticality

5.4 数据关键性

5.4.1 The decision that data influences may differ in importance and the impact of the data to a decision may also vary. Points to consider regarding data criticality include:

5.4.1受数据影响的决策的重要性可能不同，数据对决策的影响程度也可能不同。关于数据关键性的考虑要点包括：

• Which decision does the data influence?

• 数据会影响哪个决策？

For example: when making a batch release decision, data which determines compliance with critical quality attributes is normally of greater importance than warehouse cleaning records.

例如：当做出批放行决定时，判定是否符合关键质量属性的数据通常比仓库清洁记录更重要。

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

• 这些数据对产品质量或安全性有何影响？

For example: for an oral tablet, API assay data is of generally greater impact to product quality and safety than tablet friability data.

例如：对于口服片剂，API含量测定数据通常比片剂脆碎度数据对产品质量和安全性的影响更大。

5.5 Data risk

5.5 数据风险

5.5.1 Whereas data integrity requirements relate to all GMP/GDP data, the assessment of data criticality will help organisations to prioritise their data governance efforts. The rationale for this prioritisation should be documented in accordance with quality risk management principles.

5.5.1 尽管所有GMP/GDP数据都涉及数据可靠性要求，数据关键性的评估将有助于组织确定其数据治理工作的优先级。应根据质量风险管理原则记录优先级排序的理由。

MHRA GXP Data Integrity Guidance and Definitions

4. Establishing data criticality and inherent integrity risk

4.1 Data has varying importance to quality, safety and efficacy decisions. Data criticality may be determined by considering how the data is used to influence the decisions made.

4.2 The risks to data are determined by the potential to be deleted, amended or excluded without authorisation and the opportunity for detection of those activities and events. The risks to data may be increased by complex, inconsistent processes with openended and subjective outcomes, compared to simple tasks that are undertaken consistently, are well defined and have a clear objective.

4.4 Reduced effort and/or frequency of control measures may be justified for data that has a lesser impact to product, patient or the environment if those data are obtained from a process that does not provide the opportunity for amendment without high-level system access or specialist software/knowledge.