Yes, a CGMP workflow, such as creation of an electronic master production and control record (MPCR), is an intended use of a computer system to be checked through validation (see §§ 211.63, 211.68(b), and 211.110(a)). The extent of validation studies should be commensurate with the risk posed by the automated system. When the same system is used to perform both CGMP and non-CGMP functions, the potential for non-CGMP functions to affect CGMP operations should be assessed and mitigated appropriately.10

是的，工作流，例如电子主生产和控制记录（MPCR）的创建，是需要通过验证来检查的计算机系统预期用途（见§§211.63，211.68(b)和 211.110(a)）。验证研究的范围应与自动化系统带来的风险相称。当使用同一系统同时履行CGMP和非CGMP功能时, 应适当评估和减轻非CGMP功能影响CGMP操作的可能性。

If you validate the computer system but you do not validate it for its intended use, you cannot know if your workflow runs correctly.11 For example, qualifying the Manufacturing Execution System (MES) platform, a computer system, ensures that it meets its relevant requirements and specifications; however, it does not demonstrate that a given MPCR generated by the MES contains the correct calculations. In this example, validating the workflow ensures that the intended steps, requirements, and calculations in the MPCR are accurate and perform properly. This is similar to reviewing a paper MPCR and ensuring all supporting procedures are in place before the MPCR is implemented in production (see §§ 211.100, 211.186, and 212.50(b) and the guidance for industry PET Drugs—Current Good Manufacturing Practice (CGMP)).

如果你验证了计算机系统，但是没有验证其预期用途，你无法得知你的工作流是否正确运行。例如，确认制造执行系统（MES）平台（一种计算机系统），以确保其符合需求和标准；然而没有证明由MES产生的MPCR包含正确的计算。在此例中，工作流可确保MPCR中的预期步骤、要求和计算是准确的，并得到正确执行。这类似于审查纸质MPCR并确保MPCR在车间实施之前，所有支持性规程都能到位。（见§§ 211.100，211.186，212.50(b)，和《PET药品生产质量管理规范（CGMP）》行业指南）。

FDA recommends you implement appropriate controls to manage risks associated with each element of the system. Controls that are appropriately designed to validate a system for its intended use address software, hardware, personnel, and documentation.

FDA建议采取适当的控制以管理与系统每个要素相关的风险。采取适当的控制以验证系统符合其预期用途，包括软件、硬件、人员和文档。