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PART 11
Electronic Records; Electronic Signatures
绗?/p>
11
娆?/p>
鐢靛瓙璁板綍锛涚數瀛愮鍚?/p>
Subpart A--General Provisions
鍒嗙珷
A
涓�鑸瀹?/p>
Sec. 11.1 Scope.
11.1
閫傜敤鑼冨洿
(a)
The
regulations
in
this
part
set
forth
the
criteria
under
which
the
agency
considers
electronic
records,
electronic
signatures,
and
handwritten
signatures
executed
to
electronic
records
to
be
trustworthy, reliable, and generally equivalent to paper records and handwritten signatures executed
on paper.
鏈潯娆剧殑瑙勫垯鎻愪緵浜嗘爣鍑嗭紝鍦ㄦ鏍囧噯涔嬩笅
FDA
灏嗚涓虹數瀛愯褰曘�佺數瀛愮鍚嶃�佸拰鍦ㄧ數瀛愯褰曚笂
鐨勬墜绛惧悕鏄彲淇¤禆鐨勩�佸彲闈犵殑骞朵笖閫氬父绛夊悓浜庣焊鍒惰褰曞拰鍦ㄧ焊涓婄殑鎵嬪啓绛惧悕銆?/p>
(b)
This part applies to records in electronic form that are created, modified, maintained, archived,
retrieved, or transmitted, under any records requirements set forth in agency regulations.
This part also applies to electronic records submitted to the agency under requirements of the Federal
Food,
Drug,
and
Cosmetic
Act
and
the
Public
Health
Service
Act,
even
if
such
records
are
not
specifically identified in agency regulations.
However, this part does not apply to paper records that are, or have been, transmitted by electronic
means.
鏈潯娆鹃�傜敤浜庡湪
FDA
瑙勫垯涓槓鏄庣殑鍦ㄤ换浣曡褰曠殑瑕佹眰涓嬶紝
浠ョ數瀛愯〃鏍煎舰寮忓缓绔嬨�?/p>
淇敼銆?/p>
缁存姢銆?/p>
褰掓。銆佹绱㈡垨浼犻�佺殑璁板綍銆?/p>
鏈潯娆惧悓鏍烽�傜敤浜庡湪銆婅仈閭﹂鍝併�佽嵂鍝佸拰鍖栧鍝佹硶妗堛�嬪拰銆婂叕浼楀仴搴锋湇鍔℃硶妗堛�嬭姹備笅鐨勫憟閫?/p>
缁?/p>
FDA
鐨勭數瀛愯褰曪紝鍗充娇璇ヨ褰曟病鏈夊湪
FDA
瑙勫垯涓嬫槑纭瘑鍒�?/p>
鐒惰�岋紝鏈潯娆句笉閫傜敤浜庣幇鍦ㄥ拰宸茬粡浠ョ數瀛愮殑鎵嬫浼犻�佺殑绾稿埗璁板綍銆?/p>
(c)
Where electronic signatures and their associated electronic records meet the requirements of this
part, the agency will consider the electronic signatures to be equivalent to full handwritten signatures,
initials, and other general signings as required by agency regulations, unless specifically excepted by
regulation(s) effective on or after August 20, 1997.
涓�鏃︾數瀛愮鍚嶅拰涓庡畠鐩稿叧鐨勭數瀛愯褰曠鍚堟湰鏉℃鐨勮姹傦紝
FDA
灏嗕細璁や负鐢靛瓙绛惧悕绛夊悓浜庡畬鍏?/p>
鎵嬬鍚嶃�佺缉鍐欑鍚嶃�佸拰鍏朵粬鐨?/p>
FDA
瑙勫垯鎵�姹傜殑涓�鑸鍚嶃�傞櫎闈炶浠?/p>
1997
骞?/p>
8
鏈?/p>
20
鏃ヨ捣锛堝寘
鎷鏃ワ級鐢熸晥鍚庣殑瑙勫垯鏄庣‘鍦版帓闄ゅ湪澶栥�?/p>