�C�[�R���v���C�A���X�@21 CFR Part 11�֘A���
�C�[�R���v���C�A���X 21 CFR Part 11�֘A���
�������ꕶ���ɉ��߂̊ԈႢ��������܂��Ă��A���Ђł͐ӔC���Ƃ肩�˂܂��B
�@�{�����̉����͗\���Ȃ��s���邱�Ƃ�����܂��B
�d�q���̃��X�N
21 CFR Part 11�̗v�_�̗���
- 21 CFR Part 11�̗v�_�̗���
- �^�C�v���C�^�[�C�N�X�L���[�Y�ɂ���
- �N���[�Y�h�V�X�e���ƃI�[�v���V�X�e��
- Part11�������
21 CFR Part 11�̌o��
- 21 CFR Part 11�̌o��
- 21 CFR Part 11�̑Ή��ۑ�
- �d�q�L�^�Ɗ��҂̈��S���ɂ���
21 CFR Part 11�Ή����@
Part11���@
21 CFR Part 11�֘A���
21 CFR Part 11�|��
- Part11�O���iPreumble�j
- Part11�� �i�M��j
- Part11, Scope and Application�iFinal�j �i�M��j
- Part11, Scope and Application�iDraft�j �i�M��j
- FDA Part 11�p�u���b�N�~�[�e�B���O�̊J�ÂɊւ��āi�����j �i�M��j
- FDA �l�̗p���i�Ɋւ�21 CFR 11 (Part 11) �v���ɏœ_�����킹�����@�̎��{�\
�y�֘A�L���z
�� ��Ë@��֘A���
�� ����֘A���
�� �f�[�^�C���e�O���e�B�֘A
�� FDA�֘A���
�� �i���V�X�e��
�� �o���f�[�V����
�� J-GMP�֘A
�� PIC/S�֘A
�� ���X�N�}�l�W�����g
�� CAPA
�� CSV�֘A���
�� Part11�֘A���
�� ER/ES�w�j�֘A���
�� EDC�֘A���
�� �h�L�������g�Ǘ��V�X�e�������̍l����