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ComplianceWire 合规培训管理系统
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ComplianceWire 合规培训管理系统
提升受监管行业的合规性和 GxP 水平
ComplianceWire 是一个符合 FDA CFR Part 11 验证要求的合规培训管理系统，可适配培训规模，以应对监管要求和行业标准。该系统可助力确认法规要求，自动完成培训并实施风险管理，以支持开发更安全、更有效的医疗产品。
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ComplianceWire 本身就符合 FDA 21 CFR Part 11 的标准，并预置了众多监管机构要求的报告，可助力您自信应对来自监管机构和内部部门的审核。
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ComplianceWire 定期接受内部审计和客户审计。我们的客户平均每年对 ComplianceWire 进行 50 多次审计，包括纸质、远程和现场审计。
通过 ComplianceWire提供的生命科学在线学习资料库增长专业知识
让我们助力您改善合规性，应对美国食品和药物管理局 (FDA) 对医疗器械和药品的监管要求。我们的课程目录中包含 400 多门生命科学在线学习课程，其中许多课程是与 FDA 共同开发的。
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UL Solutions 提供 1,000 多门标准法规和知识型在线学习课程，包括 21 CFR Part 820 培训、508 合规性在线学习、CAPA 培训等。
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包括固定格式的专题视频、嵌入式互动和测验，由熟练的课程设计专家制作。
在业务流程中提高质量和合规性
提高质量管理意识，不仅关注制造质量，更将质量作为助力整个企业降低风险的重要支柱。
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ComplianceWire 现在是 ULTRUS 软件的组成部分，ULTRUS 汇集了 UL Solutions 的旗舰数字产品，以助力客户应对监管、供应链和可持续性挑战。
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