Part11の経緯と動向

Part11の経緯と動向

21 CFR Part11(以下、Part11)は、ペーパレスを実現するため、米国製薬業界の要請を受けて「電子署名」利用のための指針をFDAが検討したのが発端である。
Part11は1997年3月20日に発表されて以来、これまで一度も改定されていない
しかしながら、日進月歩のコンピュータの世界にあって、25年も前に作成されたルールが現在も通用するものではない。
Part11を運用するうち、当初は電子署名に注目していたが、電子記録の方がより重要であることが認識された。
Part11施行後に、電子記録・電子署名に関する新たな知見が見出され、FDAはPart11を改定しないまま、運用により期待や指導を変更してきた。Part11は改定されていないため、最新のFDAの期待や指導は記載されていない。
Part11の条文解釈の難解さと要件遵守の困難さ(特にコンプライアンスコスト)から、業界はFDAに対し、幾度もPart11の取り下げ(緩和)を要求した。
Part11の指摘を恐れるばかりに、多くの企業が紙媒体へと、いわば先祖返りをしてしまった。FDAは、電子で査察を行いたいのである。検索が早く、多くの記録を調査出来るためである。企業が電子化を躊躇することはFDAにとっても好ましいことではない。
現在、FDAは電子か紙媒体かではなく、データインテグリティについて関心がある。

Scope and Application

FDAは、2003年9月に「Scope and Application」を発行して、リスクベースドアプローチをとることを提唱した。
いたずらにコンプライアンスコストを高めると、製品の価格に転嫁され、患者負担になる。FDAは、医療費の高騰にもセンシティブである。
リスクベースドアプローチでは、患者の安全性、有効性、製品の品質に焦点をあてなければならない。
Part11が厳しく適用されるのは、生データが中心である。文書は別の管理が必要だ。そもそも悪意をもって文書を作成すれば、セキュリティや監査証跡の機能をもっても不正は防げないからだ。
注意しなければならないことは、Part11やScope and Applicationは、今でも有効であるということである。
Part11不遵守を懸念し、紙媒体に印刷したものを“正”とする企業が多く見受けられるが、本末転倒である。最終形式が紙媒体であったとしても、電子記録を作成した時点からPart11は適用される。
2001年以降、Part11を根拠としたワーニングレターは発行されていない。そもそも“Part11査察”というものは存在しない。
2010年以降にPart11に関する査察(調査)が再開されたが、ヒト用の医薬品に限定している。その目的はOOS(Out of Specification:規格外製品)の監視である。故意であれ事故であれ、記録が改ざんされた場合、患者の安全性に問題が生じるためである。

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