RegGuard用AI自动解析复杂药政法规,帮企业合规团队高效准确地应对多国监管变化。
RegGuard: AI-Powered Retrieval-Enhanced Assistant for Pharmaceutical Regulatory Compliance
- 通过分层语义切块技术,智能拆分长篇法规文本并保持跨段落一致性。
- 采用领域自适应重排模型,提升检索结果的相关性与上下文聚焦度。
- 支持审计追踪与权限控制,适合对合规性要求严苛的医药或金融领域。
日益频繁且复杂的监管更新给跨国制药企业带来巨大负担。合规团队需在不同司法管辖区、格式和监管机构之间手动解读不断演变的规则,成本高且易出错。我们提出RegGuard,一个工业级AI助手,旨在自动化解析异构监管文本,并将其与企业内部政策对齐。系统通过安全管道接入多种文档源,借助两项新组件提升检索与生成质量:HiSACC(分层语义聚合用于上下文切块)能将长文档语义分割为连贯单元,同时保持非连续部分的一致性;ReLACE(药政列表式自适应交叉编码器)基于开源模型构建,联合建模用户查询与候选结果,显著提升排序相关性。在企业环境中评估表明,RegGuard在相关性、事实依据性和上下文聚焦方面均提升答案质量,同时大幅降低幻觉风险。系统架构具备可审计性与可追溯性,支持溯源追踪、访问控制和增量索引,能快速响应动态文档源,适用于任何对合规性要求严格的领域。
原文摘要 · Abstract (English)
The increasing frequency and complexity of regulatory updates present a significant burden for multinational pharmaceutical companies. Compliance teams must interpret evolving rules across jurisdictions, formats, and agencies, often manually, at high cost and risk of error. We introduce RegGuard, an industrial-scale AI assistant designed to automate the interpretation of heterogeneous regulatory texts and align them with internal corporate policies. The system ingests heterogeneous document sources through a secure pipeline and enhances retrieval and generation quality with two novel components: HiSACC (Hierarchical Semantic Aggregation for Contextual Chunking) semantically segments long documents into coherent units while maintaining consistency across non-contiguous sections. ReLACE (Regulatory Listwise Adaptive Cross-Encoder for Reranking), a domain-adapted cross-encoder built on an open-source model, jointly models user queries and retrieved candidates to improve ranking relevance. Evaluations in enterprise settings demonstrate that RegGuard improves answer quality specifically in terms of relevance, groundedness, and contextual focus, while significantly mitigating hallucination risk. The system architecture is built for auditability and traceability, featuring provenance tracking, access control, and incremental indexing, making it highly responsive to evolving document sources and relevant for any domain with stringent compliance demands.
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