AI Driven Workflow for Regulatory Document Summarization

Regulatory Submission Document Condensation

1. Document Collection

1.1 Identify Required Documents

Gather all necessary regulatory documents, including clinical trial reports, safety data, and manufacturing information.

1.2 Centralize Document Repository

Utilize a cloud-based document management system to store all relevant documents in a centralized location, ensuring easy access and version control.

2. Data Preprocessing

2.1 Data Cleaning

Remove any redundant or irrelevant information from the documents to ensure clarity and conciseness.

2.2 Formatting Standardization

Standardize the format of all documents to ensure uniformity, making it easier for AI tools to process the information.

3. AI Summarization Implementation

3.1 Selection of AI Summarizer Tools

Choose appropriate AI-driven summarization tools. Examples include:

• IBM Watson Natural Language Understanding: Leverages natural language processing to extract key insights from documents.
• Genei: Provides automated summarization of lengthy texts, ideal for regulatory documents.
• QuillBot: Offers paraphrasing and summarization capabilities to condense information effectively.

3.2 Configuration of AI Tools

Set parameters within the chosen AI tools to define the desired length and focus of the summaries, ensuring alignment with regulatory requirements.

3.3 AI Summarization Process

Run the AI tools on the preprocessed documents to generate concise summaries. Review the output for accuracy and relevance.

4. Quality Assurance

4.1 Manual Review

Conduct a thorough review of the AI-generated summaries to ensure they meet regulatory standards and accurately reflect the original documents.

4.2 Feedback Loop

Implement a feedback mechanism to refine the AI tools based on reviewer comments, enhancing future summarization accuracy.

5. Finalization and Submission

5.1 Document Compilation

Compile the approved summaries into a cohesive regulatory submission document.

5.2 Submission to Regulatory Authorities

Submit the finalized document to the relevant regulatory authorities, ensuring adherence to submission guidelines and timelines.

6. Post-Submission Review

6.1 Performance Analysis

Analyze the submission process and the effectiveness of AI tools used, identifying areas for improvement.

6.2 Continuous Improvement

Implement changes based on the analysis to enhance the workflow for future regulatory submissions.