Zeroing out 'Writing' Time for Pharmaceutical QA｜AI SaaS from UTokyo Matsuo Lab's EQUES Supports Automatic Generation of Deviation Reports and Annual Reviews, Realizing DX in Quality Management

EQUES Co., Ltd. (Head office: Bunkyo-ku, Tokyo; Representative Director: Naoki Kishi; hereinafter "EQUES"), a startup originating from UTokyo Matsuo Lab, announces the release of new automatic generation functions for "Deviation Reports," "Quality Information Reports," and "Annual Reviews," in addition to the previously offered "Change Request Forms" in its AI SaaS "QAI Generator" for streamlining documentation related to pharmaceutical manufacturing quality assurance (QA). This update will contribute to further operational efficiency and quality improvement in the pharmaceutical industry's quality assurance operations.

■ Background of the Update｜Improving the Burden of Quality Assurance (QA) Operations

Quality Assurance (QA) operations in the pharmaceutical industry require the creation and review of a wide variety of documents stipulated by ministerial ordinances. Including verification work involving other departments, this places a significant burden on the operational staff. Furthermore, the QA domain is highly specialized, and a shortage of human resources is an industry-wide challenge.

To solve these challenges, EQUES released "QAI Generator" and, as its first phase, provided an AI automatic generation function for change request forms. While we received high evaluations from our client companies regarding operational efficiency, we also received numerous strong requests to "streamline other standard documents and more time-consuming reports using AI."

In response to these voices, we have expanded our coverage to three types of documents: "Deviation Reports" and "Quality Information Reports," which are frequently created in QA operations and require specialized knowledge and accurate descriptions of factual information, and "Annual Reviews," which require the aggregation of vast amounts of data.

■ Overview of Newly Added Supported Documents

The automatic generation functions for the newly added supported documents are as follows:

1. Deviation Report (Deviation Management)

For deviations from procedures occurring in manufacturing processes, etc., AI organizes the situation of occurrence, root cause investigation, proposed corrective and preventive actions (CAPA), etc., into logical text based on simple notes and circumstances entered into a specified form, and rapidly generates a draft.

2. Quality Information Report (Quality Information Management)

Information related to quality received from the market or medical sites (complaints...