2013年1月1日に改定されたPIC/S GMP ANNEX 11 「Computerised Systems」の原則には以下のような記載がある。『マニュアルベースの作業をコンピュータ化システムに置き換える場合、結果として製品の品質、プロセスコントロールつまり品質保証を劣化させてはならない。プロセスの全般的なリスクが増えてもいけない。』これはコンピュータ化システム（自動化システム）を導入する上での原則である。マニュアルベースの作業（手作業）をコンピュータ化（自動化）した際に、以下の3つを保証しなければならない。
- 製品の品質を劣化させない。
- 製品の品質保証を劣化させない。
- リスクを増やさない。
ということである。
たとえば、昔はお米をお釜で炊いていた。手作業で「はじめちょろちょろなかぱっぱっ 赤子泣いても蓋とるな」といった具合に、口伝でおいしいお米の炊き方を継承してきた。
現代では、お釜はマイコン炊飯ジャーにとって変わった。”マイコン”とはマイクロコンピュータの略である。すなわちお釜というハードウェアにICチップが搭載されており、ファームウェアと呼ばれる小さなプログラムによって制御（コントロール）されている。
マイコン炊飯ジャー（自動化システム）において重要なことは、
- お釜でお米を炊いていた時と同じおいしさ、食感、甘さ、艶加減で炊き上げる。（品質を劣化させない）
- 炊飯する度に品質が異ならない。（品質保証を劣化させない）
- 食中毒を起こさない。（リスクを増やさない）
ということである。
つまりバリデーションの目的は、手作業で出来ていたことと同じ事が、コンピュータ化されたシステムでも出来なければならないということである。
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