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  6. Data Integrity Response "dbs for pharma"

Data Integrity Response "dbs for pharma"

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last updated:Sep 03, 2020

フィラーシステムズ
フィラーシステムズ
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Safe Excel use with Di support

The screen remains as Excel as before, and the data goes to the server. Excel files will not remain on the client. It is possible to manage original Excel files, data management, audit trails, electronic approvals, and printed materials. In the pharmaceutical industry, Excel has been used in many situations for GMP operations. However, with the recent tightening of Data Integrity (DI) regulations, there has been a shift towards not using it. It has become common to hear stories about being pointed out during FDA inspections. This dbs for Pharma (dbSheetClient) overcomes the above challenges and allows for the continued enjoyment of Excel's convenience in GMP operations. Furthermore, managing printed materials is a significant point in DI, and by using the optional DI printer, management of forms (blank sheets), SOPs, and records can be handled on a per-page basis.

    DatabaseDocument and Data Management
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Data Integrity Response "dbs for pharma"

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basic information

- The screen remains as your Excel. - The entered data is stored in the database. - The original Excel is managed on the server. - Users can manage it. - Audit trails for input, changes, deletions, etc., can be obtained. - Printed materials can be managed.

Price range

P5

Delivery Time

P4

Applications/Examples of results

○Creation and management of spreadsheets used for various operations that require audit trails ○Basic compliance with Di, ER/ES, and Part 11

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フィラーシステムズ

フィラーシステムズ

IT/Telecommunications

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Since our establishment in October 2007, we have been committed to contributing to the development of pharmaceuticals, medical devices, health foods, and cosmetics through IT, providing numerous IT solutions across various industries. Now, we have an increasing number of talented individuals from China, South Korea, the Philippines, Indonesia, and Nepal, creating a diverse international environment where native checks in English, Chinese, Korean, and Indonesian are possible within our company. Additionally, our engineers are confident in implementing the most suitable systems tailored to our clients, more so than any other IT company. Please feel free to consult with us.

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