Client success story
Automated LLM Generation of GxP Documents
Business Value: Reduced Regulatory Risks and Lowered SME Labor Costs
Summary: Deploy LLM Technologies to Accelerate GxP Document Generation
Pharmaceutical research and manufacturing operations produce many structured internal and external documents as part of GxP requirements, which is costly and time consuming. bPrescient accelerates the ability to generate these documents by deploying LLM technologies to draft the initial outline structure and content of documents based on training from past document sets.
Challenge: Reduce SME Labor Costs
Generating regulated documents is time consuming and onerous. Companies generally use document templates to standardize and accelerate the generation of required documentation. Nevertheless, generating the documentation still requires large amounts of Subject Matter Expert (SME) effort for drafting relatively repetitive and standard content.
Solution: bPrescient Experts Fine-Tune Base LLM Models
bPrescient fine-tunes base LLM models on specific document types and provides agents that generate the first iteration of documents on demand. Examples include generating the outline of a Process Performance Qualification Protocol or a draft Periodic Compliance Report. Combining these capabilities with Structured Data Management Tools allows the automated generation of document outlines, structured data tables, and narrative content as a first draft, thereby allowing SMEs to focus on editing the drafts and ensuring accuracy and correct meaning.
Outcome: Domain-Specific LLM Optimizes SME Resources
These solutions greatly reduce the burden of generating regulated documentation, increase the quality of the final outputs, and reduce the associated risk and cost.
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