FDAは1999年に紙媒体の記録に期待されるものと同じ基本的な電子データの品質要件としてALCOAを提唱した。
【ALCOA】
電子データが紙の記録と同じ以下の属性を持つ状態のこと。
A – データ生成者に帰することができること（Attributable）
L – 読みやすく恒久的であること （Legible）
C- 同時的であること（Contemporaneous）
O – オリジナルの記録（または真正なコピー）であること（Original）
A – 正確であること（Accurate）
FDAが提唱したALCOAは紙媒体および電子による“生データ”および“原資料”のみを対象としている。またその内容は「真正性」（Attributable、Contemporaneous、Original、Accurate）と「見読性」（Legible）の要件である。
【ALCOA+】
これに対し、2010年にEMAが発出したREFLECTION PAPER ON EXPECTATIONS FOR ELECTRONIC SOURCE DOCUMENTS USED IN CLINICAL TRIALSにおいて「真正性」の要件としてCompleteとConsistentを加えた。これらは生データのみではなく加工されたデータを含んでいる。
また「見読性」の要件としてAvailable、「保存性」の要件としてEnduringを加えてALCOACCEA（ALCOA+）とした。
ALCOAに加えて、以下の属性をもつこと。
C – 完全であること（Complete）
C – 一貫性があること（Consistent）
E – 恒久的であること（Enduring）
A – 利用可能であること（Available）
なお、本ガイドラインはFDAとは異なり電子記録のみを対象としている。
Availableは保存された電子記録が検索可能（アーカイブを含む）であること、最新のシステムで読み出せることを要求している。
Enduringは記録を保存した電子メディアの保存状態の監視監督や耐用年数以内での新メディアへの移行を求めている。
果たしてデータインテグリティに記録保存後の見読性と保存性の要件を含めるべきかどうかは議論が必要であろう。
ALCOA＋では、データインテグリティの要求で重要なSecure要件が足りない。
【お知らせ】イーコンプライアンスでは『データインテグリティSOP作成セミナー』を販売しています。
VOD配信または【セミナービデオ】をご選択いただけます。
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