Effects of the recent legal and voluntary regulations on documents management : The cases of pharmaceutical companies(Records Management and Archival Management in Private Companies)

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  • 近年の法的規制・自主規制が文書管理に与える影響 : 医薬品企業の場合(<特集>「企業のレコード・マネジメント、アーカイブ・マネジメント」)
  • 近年の法的規制・自主規制が文書管理に与える影響--医薬品企業の場合
  • キンネン ノ ホウテキ キセイ ジシュ キセイ ガ ブンショ カンリ ニ アタエル エイキョウ イヤクヒン キギョウ ノ バアイ

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Abstract

In Japan, the Pharmaceutical Affairs Law regulates various documents which pharmaceutical companies shall create and archive. This article discusses effects of the recent enactment and revision of laws on documents management at pharmaceutical companies, based on several medication scandals and lawsuits. Since organizational documents are at risk of disclosure for other people and/or organizations, documents management should be strict and reliable for the third person. On the other hand, company information should be open in advance because evaluation of intellectual properties of the company becomes important. In this situation, it is necessary for the company to promote strategic use of its information and to understand the role of top management and records managers for such use.

Journal

  • Records Management

    Records Management 48 (0), 29-48, 2004

    Records Management sosiety of Japan

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