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Ç¥Áؿ¹æ¹ýÀº ¿¬±¸°³¹ß°ú »ý»ê´Ü°èÀÇ ÀÛ¾÷¼ø¼·Î Á¤ÀǵǸç, ´Ü°èº°·Î ´ÙÀ½°ú °°ÀÌ ±¸ºÐµÈ´Ù:
Á¦Ç°±â´É Á¤ÀǴܰè, Functional Specifications (FS)
Á¦Ç° µðÀÚÀÎ Á¤ÀÇ ´Ü°è, Design Specifications (DS)
Á¦Ç° ½ÃÇè°úÁ¤, testing procedures
Á¦Ç°°ü·Ã ¹®¼ °ø°³ ´Ü°è, product release documents
Á¦Ç°ÀÇ °íÁõ ´Ü°è, product documentation
Á¦Ç° º¸Áõ Á¤ÀÇ ´Ü°è, certificates
½ÃÈİü¸®¹ý Á¤ÀÇ ´Ü°è, service guidelines
Ç¥Áؿ¹æ¹ýÀº ǰÁú°ü¸® ÀÚ·áÀÇ Á¶Á¤°ú ¼öÁ¤À» °ü°èµÈ ¸ðµç Á¤º¸¸¦ °¢°¢ÀÇ ±ÔÄ¢¿¡ ÀÏÄ¡ÇÏ°Ô ÀÛ¼ºµÈ´Ù.
SOP 100 "QA Fundamentals"ÀÇ ±¸Á¶.

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| 21 CFR Rule 11 |
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