文書・記録の作成、公開、パブリックコメントの収集、確認(レビュ)、修正、承認、保存、検索、印刷、版数管理等を扱う。
規定、基準書、手順書(以下、SOP等という)、製造指図等の文書の作成過程の管理と成果物の管理をおこなう。
また、各種記録(変更記録、不適合記録、CAPA等)の作成、承認過程の管理と保管をおこなう。
医療機器企業においては、規制当局(FDA、厚労省など)の査察が避けて通れない。
規制当局の査察は、1つの事象を狭く深く調査することが一般的である。文書はプロセスの記録であり、正しくプロセスを実行した証拠となる。また各プロセスは関連性や依存性があり、その成果物である文書も当然関連性を管理しなければならない。1つの文書がどういう経緯で作成され、どの文書に引き継がれたかというトレーサビリティを管理する機能が必要である。
文書のレビュにおいて、確認者が電子的に直接コメントを当該文書に付与する機能が必要となる。
文書を印刷し、朱筆を入れる作業は、知識が組織に残らず、品質やスピードの改善につながらない。また紙によるレビュは、不適切な版(バージョン)に行うこともあり、二度手間等が発生するリスクもある。
またセキュリティの確保(外部への情報の漏洩を防ぐ)も必要である。
文書管理システムの要件(抜粋)
FDA査察対応機能要件
- 版数管理が可能であること。
最新版のみの管理ではないことに注意。 - 即座に適切なSOP等が検索・表示可能であること。
- 当該文書(設計図、SOP等)が有効であった期間での検索ができること。
- 全文検索ができること。
- シソーラス検索ができること。
例:国会で検索した場合、衆議院も検索にかかる。 - 特定の期間で過去に有効であったSOP等を検索できること。
ある時点で、各文書がどのバージョンであったかを検索できる機能である。 - SOP等の改訂において変更点が管理できること。
- トレーサビリティが管理できること。
例:苦情報告書→変更されたSOP等→教育の記録 - 文書間のリンク付ができること。
関連する文書間でリンクを張る機能である。検索時に芋づる式に文書が見つかる利点がある。 - スナップショットが作成できること。
ある一時点における文書群を、特定バージョンとともに管理する機能である。DHF作成などに利用する。
査察時には、ある過去の時点について調査を受ける場合があり、その時点での最新の文書をスナップショットとしてまとめておく必要がある。 - 作成・変更・削除の責任の所在を管理できること。
作成者、変更者はオペレータとは限らない。
作成・改訂・承認過程管理機能要件
- ワークフローが作成できること。
- テンプレートを管理することができること。
- 文書テンプレートを適用できること。
文書はテンプレートから作成できなければならない。
質の良いドキュメントを作成するためには、質の良いテンプレートを準備しておかなければならない。 - ドラフト文書を適切な複数の確認者(Reviewer)に送付できること。
- 確認者(Reviewer)は、当該文書にアノテーションが付与(コメント付与)できること。
- アノテーションが保存できること。
レビュ過程で付与されたアノテーション(コメント)を、データベース化できる機能である。
ナレッジをデータベースとして蓄えていく必要がある。 - 保存されたアノテーションを、テンプレートに容易に反映できること。
- レビュの完了した文書は、作成者に返却できること。
- レビュの完了した文書は、アノテーションと共に作成者が参照できること。
- レビュの完了した文書は、承認者に送付し、承認が行えること。
- 作成、確認、承認時に電子署名が実施できること。
- 電子署名は、Part11の要求事項を満たすこと。
- 電子署名は、いかなる状況下においても当該文書とリンクが外れないこと。
画面表示、印刷、電子メール(pdf)による送信
印刷時、pdf出力時に、電子署名情報が出力されること。 - 文書の作成・改訂・承認ステータスを管理できること。
文書の作成過程において、ステータスを管理し、各文書の作成状況を管理する機能である。
個人毎の進捗管理や未作業項目の管理もできることが望ましい。 - 承認前の文書は、作成・改訂グループ以外は参照できないようにすること。
- 文書の変更点が管理できること。
- パブリックコメントを収集できること。
- オーナーシップを変更できること。
- 組織の変更や、文書のステータスの変更に伴い、オーナーシップを変更する機能である。
- 当該文書の日本語版と英語版がリンクできること。
翻訳版がない場合は、その旨表示すること。
従業員・供給者への配布機能要件
- 最新版の配布を保証できること。
一般従業員には、最新版のみを参照させることが必要である。 - 参照は、pdf版でおこなうこと。
- 印刷した場合、Uncontrolled Copyが印字されること。
- 開示(社外)バージョンと社内バージョンの管理ができること。
社内では、文書の作成過程を管理するため、社内的なバージョン管理が必要である。しかしながら、社外に開示する場合、必ずしも社内のバージョン番号とは限らない。
アーカイヴ機能要件
- 文書をアーカイヴできること。
古い文書をアーカイヴする機能。故意や事故によるドキュメントの変更・削除を防止するとともに、アクティブなドキュメントの検索スピードを向上させ、日々のバックアップ時間と容量を軽減することができる。 - アーカイヴした文書を検索できること。
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