Digitize and streamline regulatory change management.
Efficiently and successfully manage the complex regulatory compliance and GxP control process using this offering by Blueprint Systems, the Gartner-recognized agile planning and compliance management software provider, that accelerates and de-risks the digital transformation of large organizations.
Access both regulatory and business artifacts (source regulations, decomposed into individual obligations, interpretations, processes, policies, procedures and controls and related system requirements) in Storyteller’s unified, versioned, secure and scalable repository. The system proactively identifies policies, controls and processes potentially impacted by a regulatory change and maps to relevant business units with Storyteller’s Intelligent Recommendations. The pre-built integration to leading development and operations tools helps ensure downstream system regulatory compliance, and a REST API integration to existing GRC and quality management systems is included.
Gain the visibility needed to effectively and efficiently manage regulatory changes with detailed mappings of all Cortellis Regulatory Intelligence information through all business assets and even into operational business system data (data lineage). Analyze the impact and likelihood of risks related to regulatory updates using the highly visual events mapping engine in Storyteller for Regulatory Compliance. Understand the inter-relationships from source regulation through remediation so you can thoughtfully plan for regulatory change. Filter and distribute regulatory change feeds as alerts, using Intelligent Interpretation, to the right stakeholders for assessment.
Prioritize and oversee resources through the remediation process with Storyteller’s automated workflow and collaboration engine. Assign, collaborate, review and approve with electronic meaning of signature capability. The full remediation process, including in-line discussions, can be mapped to closure and tracked in real time.
Perform gap analysis to oversee compliance progress and obligations for remediation. Gain clear, centralized, executive-level visibility into your organization’s capacity to respond to regulatory changes across the organization. Produce offline documentation for your permanent record. Collect, organize and manage all required evidence and associate it back to regulatory interpretations to demonstrate compliance for internal and external auditors. Leverage the ability to reference baselines that are sealed in time to further support the audit process.
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