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No matter how much we want, paper is there, it has been there, I know people have been trying to solve this problem and they will solve it, but in the meantime paper continues to exist and there is a wealth of information sitting in the paper.
If you are recording on paper, we can consume the data, we can mix it with other data and then and make it and make the insights available to you, right. And we do it in a CFR part level blessed way, so there is a method to the madness, we extract the information and the information that comes out, you know it comes with some kind of a confidence factor.
So, when the for the low confidence ones, there is a human in the loop that comes in that can basically look at it and basically verify it is correct or wrong, because this piece of information will be used in terms of generating insights that will be relevant for you know that we use for making decisions on that.
But this is a very important cog in the wheel in order to keep the whole thing very flexible between internal manufacturing, external manufacturing and bringing all of those pieces in, because you may not have control over all of your third party vendors, your CMOs or your external testing labs, a lot of them might just basically dump a piece of paper at you saying that here is the piece that you requested and then you it is up to you to decide how to use it.
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Frequently Asked Questions
Mareana has helped numerous firms in the Pharmaceutical, Chemical, Medical Device, and Industrial Manufacturing industries.
Paper-to-digital data extraction is the process of converting information from paper records into structured digital data using technologies such as AI, machine learning, and optical character recognition (OCR). This enables manufacturers to analyze, share, and use data more effectively for operational and compliance purposes.
AI can automatically extract information from paper documents, organize it into digital formats, and combine it with other data sources. This allows organizations to generate real-time insights, improve decision-making, enhance quality management, and increase operational efficiency.
Human-in-the-loop validation is a process where human reviewers verify AI-extracted data when confidence scores are low. This additional review helps ensure data accuracy and reliability, especially when the information is used for regulatory compliance and critical business decisions.
CFR Part 11 is an FDA regulation that governs electronic records and electronic signatures. Compliance ensures that digital records are secure, traceable, trustworthy, and acceptable for regulatory audits, making it essential for pharmaceutical and regulated manufacturing environments.
Manufacturers can use AI-powered data extraction platforms to capture information from paper reports, certificates, and laboratory documents provided by vendors, contract manufacturers, and testing facilities. The extracted data can then be standardized and integrated into enterprise systems for analysis and reporting.
Key benefits include:
- Reduced manual data entry
- Faster document processing
- Improved data accuracy
- Better regulatory compliance
- Enhanced operational visibility
- Improved decision-making capabilities
- Easier integration with enterprise systems
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