Life Science — Regulatory Document Generation Automation

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This DAG automates the generation of regulatory documents from various data sources, enhancing compliance and reducing turnaround times. It ensures quality control and provides actionable insights through monitoring KPIs.

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Overview

The purpose of this DAG is to streamline the generation of regulatory documents essential for the life sciences industry, thereby improving compliance and efficiency. It ingests data from multiple sources, including ERP transaction logs, CRM records, and laboratory information management systems (LIMS). The ingestion pipeline processes this data through a series of steps that include data validation, quality control checks, and document formatting. Quality controls are integral to the process, e

The purpose of this DAG is to streamline the generation of regulatory documents essential for the life sciences industry, thereby improving compliance and efficiency. It ingests data from multiple sources, including ERP transaction logs, CRM records, and laboratory information management systems (LIMS). The ingestion pipeline processes this data through a series of steps that include data validation, quality control checks, and document formatting. Quality controls are integral to the process, ensuring that the generated documents meet regulatory standards and are free from errors. The outputs of this DAG are compliant regulatory documents in required formats, such as PDF and Word, ready for submission to regulatory authorities. Monitoring key performance indicators (KPIs) such as document generation time and compliance rates allows for continuous improvement of the process. In case of any failures during the document generation, a robust recovery system is in place to ensure business continuity and minimize disruptions. The business value lies in reducing the time and resources spent on document preparation, thereby allowing life sciences companies to focus on core activities such as research and development while ensuring adherence to regulatory requirements.

Part of the Document Automation solution for the Life Science industry.

Use cases

  • Significantly reduces document preparation time
  • Enhances compliance with regulatory standards
  • Improves accuracy and reduces human error
  • Facilitates faster submission to regulatory bodies
  • Enables better resource allocation for core activities

Technical Specifications

Inputs

  • ERP transaction logs
  • CRM records
  • Laboratory information management system (LIMS) data
  • Clinical trial data
  • Quality assurance reports

Outputs

  • Regulatory submission-ready PDF documents
  • Formatted Word documents
  • Compliance reports
  • Audit trails of document generation
  • Error logs for quality control

Processing Steps

  1. 1. Ingest data from ERP, CRM, and LIMS
  2. 2. Validate data for accuracy and completeness
  3. 3. Perform quality control checks
  4. 4. Format data into regulatory document templates
  5. 5. Generate output documents in required formats
  6. 6. Log generation metrics and compliance rates
  7. 7. Implement recovery protocols for failures

Additional Information

DAG ID

WK-1452

Last Updated

2025-01-17

Downloads

14

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