AI innovating
Communicates in natural language with all Quality Assurance documentation, such as SOPs, change requests, CAPAs, batch records, and regulations.
The Background
About Quality Assurance (QA)
QA in the pharmaceutical industry is a set of activities and processes aimed at ensuring that drugs meet strict safety standards, avoiding contamination and manufacturing defects.
The key focus is on ensuring the well-being and health of the end user.
Why is this important?
In addition to ensuring compliance with industry safety standards, QA plays a crucial role in:
- Ensuring compliance with international regulations, such as those of the EMA (European Medicines Agency) and FDA (Food and Drug Administration)
- Reducing risks at all stages, from production to packaging
- Deploying continuous monitoring to optimize processes, reducing costs and waste
The Problem
In the pharmaceutical industry, QA requires the careful management of a large number of closely interrelated documents and procedures.
Documents and procedures to be verified
A wide range of documents (SOPs, change requests, CAPAs, batch records, etc.) must be checked regularly to ensure accuracy and compliance.
Interconnection and frequent updates
Information is interconnected and requires continuous updates to reflect operational, regulatory, scientific, and technological changes.
Accuracy and regulatory compliance
A high level of accuracy is required to ensure compliance with strict regulations (FDA, EMA) and guarantee maximum protection of patient health.
The Sogetel solution
Starting from a base of approximately 67,000 documents relating to pharmaceutical quality assurance, Sogetel developed AQUA Pharma by fine-tuning existing LLMs.
Through a simple web application, the solution allows you to:
Interact with documents in natural language
Thanks to the ability to consult and interact with documentation in natural language, users can simplify the search and interpretation of content, making the entire process more efficient and accessible.
Identify accurate answers and inconsistencies
The use of LLM allows you to receive quick and accurate answers regarding regulatory and technical aspects, as well as detect inconsistencies and possible errors in documents, ensuring greater reliability and accuracy.
Optimize verification and review processes
Automate document review, reducing the time needed to identify correlations, increasing accuracy, and improving overall efficiency.
CENTRALIZED MANAGEMENT OF DOCUMENTS AND QA REGULATIONS
Information is accessible via a search engine that allows you to ask questions in any language and obtain clear, comprehensive answers covering the entire available document domain. The solution can be installed on-premises, ensuring control and security over data.
Architecture
AQUA PHARMA uses RAG (Retrieval-Augmented Generation) architecture to eliminate hallucinations and provide answers based exclusively on the company’s knowledge base, thanks to a solid, modular structure that can also be installed on-premises.
Learn more about AQUA Pharma
Contact us to see a demo and learn more about the features of our solution.
