Yes. The principles of quality risk management may be applied during the review of electronic data and review by exception is permitted, when scientifically justified.

是的，质量风险管理的原则可以在审查电子数据的过程中应用，在有科学依据的情况下，允许例外审查。

Exception Reporting is used commonly as a tool to focus the review of electronic data such as (but not limited to) electronic batch records. Exception reporting rapidly highlights to the reviewer one of the most critical elements of batch review, i.e. the exceptions. The level of review of the full electronic batch record can vary based on the exceptions as well as the level of confidence and experience with a particular process. Appropriate testing and validation must be completed for the automated system and the output Batch Exception Report to ensure its functionality meets the business and regulatory requirements as per GMP.

异常报告通常被用作重点审查电子数据的工具，如（但不限于）电子批次记录。异常报告能迅速向审查者强调批次审查中最关键的因素之一，即异常情况。对完整的电子批次记录的审查水平可以根据例外情况以及对某一特定过程的信心和经验水平而有所不同。必须对自动化系统和输出的批次异常报告完成适当的测试和验证，以确保其功能符合GMP规定的业务和监管要求。