Forefront of intellectual property protection with e-Laboratory Notebook

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  • HARADA Akihiko
    Fujitsu Limited Technical Computing Solutions Unit HPC Application Solutions Div.
  • MASUGI Nanako
    Fujitsu Limited Technical Computing Solutions Unit HPC Application Solutions Div.

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  • 電子実験ノートを用いた知的財産保護の最前線
  • デンシ ジッケン ノート オ モチイタ チテキ ザイサン ホゴ ノ サイゼンセン

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Description

For brand-name drug companies, it is a critical issue that their employees maintain laboratory notebooks which are admissible as evidence in a patent dispute. In order for a laboratory notebook to be admissible in court, it needs to ensure completeness, searchability, integrity and substantiation therein. These requirements were achieved by digitizing laboratory notebooks themselves and using templated formats, search functions, data backup system, audit trail functionality and long-term signature services.To meet the demand, we have made e-Laboratory Notebook available in protecting the intellectual property by fulfilling the requirements defined in FDA 21 CFR Part11 and applicable to e-Laboratory Notebook and by applying Computerized System Validation which guarantees that the system fulfills the above requirements.

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