ISPE：如何验证数据完整性？.pdfVIP

ISPE 指南《生产系统数据完整性指南》给出了有关数据完整性的验证要点，如 下： Verify per procedures below. 根据下列程序（应有）进行确认 • Data definition and mapping Processes • 数据界定和数据映射程序 • System design and development Processes • 系统设计和开发程序 • Good installation practices, checking wiring, grounding, segregation • 良好安装规范，线路、接地、隔离检查 • Good maintenance practices and asset management • 良好维护规范和资产管理 • Initial validation processes for system elements • 系统要素的初始验证程序 • Initial validation processes for system interfaces • 系统通信接口的初次验证程序 • Security management processes and segregation of duties (includin g logical and physical security where appropriate) • 安全管理程序和责任划分（包括逻辑和物理安全） • Change control processes and configuration management • 变更控制程序和配置管理 • Data retention process and regular checks of this • 数据保存程序并定期检查 • Calibration management processes that include determination of re quired accuracy, resolution, calibration period, loop calibration • 校准管理程序，包括精密度、准确度、校准周期、回路校准 • Data audit trail review process • 数据审计追踪审核程序 • Training • 培训 • SOPs and automated workflow prompts specifically cover manual da ta entries, data transcription, data processing, requiring second per son verification where appropriate • SOP 和自动化工作流图示应包含数据手动输入，数据转录、数据处理，适当 时，第二个人确认 • SOPs and automated workflow prompts specifically cover manual us age and interpretation of data outputs (e.g., SOPs for batch data re view including audit trail review, alarm responses, reconciliation acti vities) • SOP 和自动化工作流图示应包含数据输出的认为使用和解释（例如，批数据审 核SOP 应包含审计追踪审核，报警响应，平衡活动） • SOPs and automated workflow prompts specifically cover system ac tivities essential to data integrity (e.g., manual change to daylight s aving time, manual intervention in response to system alarms, proc edures set out in ISPE GAMP® 5, Operation Appendices [15]) • SOP 和自动化工作流图示应包含数据完整性所必需的活动 （如，手动更改夏令 时、系统报警时的手动干预、ISPE GAMP®5 操作附录[15]中规定的程） • SOPs and automated workflow promp