This service uses AI to cross-reference manufacturing and sales approval documents with product specifications, SOPs, manufacturing instructions, test procedures, etc., line by line, and suggests relevant sections.

AI assists with "exploration," while humans make "decisions," thereby streamlining and standardizing inspection tasks.

no.
The AI is responsible for "finding the relevant section" and "suggesting similar sentences."
The final "discrepancy judgment," "GMP judgment," and "GQP judgment" are always performed by a person.

This is not a generating AI.
This is a text matching AI that compares the meaning of different sentences and finds similarities.
Therefore, this is not a service that generates answers.

The document will look like this:
Marketing Authorization / Product Standard / SOP / Manufacturing Instructions / Test Procedures / Test Standards / MF / Official Compendium

Currently, we are focusing on PDF files.
Word and Excel files should be converted to PDF format for use. It is recommended that the PDF include text information.

PDFs containing only images and PDFs processed with OCR do not provide sufficient accuracy.
We recommend using a PDF that retains the text information.

Even if the wording of the sentences differs, we will suggest sentences that are semantically similar.
However, this does not guarantee a 100% match.
Therefore, multiple options are presented, and a person makes the final decision.

there is.
Therefore, rather than saying "the AI will make the decision"
The system will operate with "AI searching, and humans making the decisions."

yes.
It is possible to perform an operation that only reconfirms the changed parts.
Since the results of the previous comparison are carried over, only the revised parts can be viewed.

Yes, it is possible.
You can add comments explaining the reasoning and basis for your decisions, linking them to each matching result, and record them for future reference.

no.
This is a tool that supports people's decision-making.
Ultimate responsibility for quality assurance will remain with people, as before.

The AI only provides suggestions.
Because veterans' reasoning can be accumulated as comments, it helps eliminate reliance on individual expertise and is also useful for training.

The actual effect will depend on the specific task.
You will perform actual measurements using a proof-of-concept (PoC).
In past beta tests, we have seen cases where work time was reduced by approximately 40-60%.

The most effective method is "time spent searching."
This allows people to focus on making the "final decision."

yes.
During revisions, only the differences will be checked, making it even more effective.

This is particularly suitable for the following companies.

• There are many items.
• There are multiple factories.
• The burden of reviewing approval documents is heavy.
• It is becoming dependent on individuals.
• Annual inspections take time.

yes.
This is a SaaS service accessed through a web browser. No software installation is required.

It can handle up to 30 matching files for each source file.
Additionally, there is a limit of 30MB per file.

It features the security measures typical of cloud services, including communication and access management.
We will explain the details individually.

We do not use customer data for AI training.

The pricing structure is, in principle, based on an annual license for the number of pharmaceutical products covered.
For further details, please contact us via the inquiry form (https://go.macnica.co.jp/Entry-MNC-IQ-CAX.html).

After we have thoroughly reviewed the purpose and content of the verification process, you can use our 4-week free Proof of Concept (PoC) service.
Please apply through the trial page.

*Please note that depending on your purpose, this service may not be available.

Yes, we do.
We also have publicly available case studies, so please feel free to use them as reference materials.

Weekdays 9:00-12:00, 13:00-17:00 ^*1
We offer product-related Q&A support via email (in Japanese).

*1 Macnica support is provided on days excluding public holidays and Macnica designated holidays.