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APVS Computer System Validation
APVS°¡ ¸ðµç SolutionÀ» Á¦°øÇÕ´Ï´Ù
APVSÀÇ Validation Service´Â °í°´°úÀÇ ¾à¼ÓÀÔ´Ï´Ù
APVS°¡ ÀÌÁ¦ ±× °í°´°úÀÇ ¾à¼ÓÀ» ÇÑ ´Ü°è¾¿ ÀÌÇàÇϰڽÀ´Ï´Ù
APVS°¡ ValidationÀÇ »õ·Î¿î ¹®È­¸¦ ¸¸µì´Ï´Ù
APVS°¡ ValidationÀÇ »õ·Î¿î ±âÁØÀ» Á¦½ÃÇÕ´Ï´Ù
APVS°¡ Validation ¾÷°èÀÇ ¸ð¹üÀÌ µÇ°Ú½À´Ï´Ù
APVSÀÇ Validation Service´Â ¸ð¹æÇÒ ¼ö ¾ø½À´Ï´Ù


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ÀϹÝÀûÀ¸·Î, ȸ°íÀû ¹ë¸®µ¥ÀÌ¼Ç ÇÁ·Î¼¼½ºÀÇ Ãʱâ Ȱµ¿ÀÎ, Â÷ÀÌ ºÐ¼®Àº ½Ã½ºÅÛÀÇ ºñ Áؼö ¹× ºñ °ËÁõ ºÎºÐµéÀ» ¾ð±Þ ÇÕ´Ï´Ù. ¿ä¾à º¸°í¼­¿¡´Â ½Ã½ºÅÛÀ» Áؼö ¹× °ËÁõ»óÅ·Π¸¸µå´Âµ¥ ÇÊ¿äÇÑ ÃßõµÈ Ȱµ¿ ¹× °ü·Ã ¿¹»ó ºñ¿ë°ú ÇÔ²², È®ÀÎµÈ ¸ðµç Â÷À̸ñ·ÏÀÌ Æ÷Ç﵃ °Í ÀÔ´Ï´Ù. APVS´Â ºÐ¼® ¹æ¹ý, ºÐ¼® ½ÇÇà, ±×¸®°í ¿ä¾à º¸°í¼­¸¦ ÀÛ¼ºÇÒ ¼ö ÀÖ½À´Ï´Ù.
   
ȸ»çµéÀº ±×µéÀÇ Á¤Ã¥ ¹× ÀýÂ÷µéÀÌ Àß ÁöÄÑÁö°í ÀÖ´ÂÁö¸¦ È®ÀÎÇϱâ À§ÇÏ¿© Á¤±âÀû °ËÅä ¹× ³»ºÎ°¨»ç¸¦ ¼öÇàÇØ¾ß ÇÕ´Ï´Ù. ´õ¿íÀÌ, ȸ»ç´Â °¨µ¶±â°üÀÌ ¹®Á¦Á¡À» ¹ß°ßÇϱâ ÀÌÀü¿¡ ±× ¹®Á¦µéÀÇ È®ÀÎ ¹× Á¤Á¤À» À§ÇÏ¿©, ÄÄÇ»ÅÍ ½Ã½ºÅÛÀÇ »çÀü½ÂÀÎ °Ë»ç¸¦ ¿øÇÒ ¼öµµ ÀÖ½À´Ï´Ù. APVS´Â Á¤±â°ËÅä ÀýÂ÷ °³¹ßÀ» µ½°í °¨»ç ¼­ºñ½º¸¦ Á¦°øÇÒ ¼ö ÀÖ½À´Ï´Ù.
   
¹®¼­´Â ¸ðµç ȸ»çµéÀÇ ¹ë¸®µ¥ÀÌ¼Ç ÁøÃ´µµÀÇ ¸¶Áö¸· »êÃâ¹° ÀÔ´Ï´Ù. ÀÌ·¯ÇÑ ÀÌÀ¯·Î, ȸ»çµéÀº ¹®¼­ ÀÛ¼º, °ËÅä, ½ÂÀÎ, ±×¸®°í ÀúÀå¿¡ »ç¿ëµÈ ÇÁ·Î¼¼½º¸¦ öÀúÇÏ°Ô °ü¸®ÇÏ¿©¾ß ÇÕ´Ï´Ù. ´õ¿íÀÌ È¸»çµéÀº ¹®¼­µéÀ» »öÀÎÈ­ ÇÏ°í ºñ½ÂÀÎµÈ »ç¶÷µé·ÎºÎÅÍ ¹®¼­¸¦ º¸È£ÇÒ ½Ã½ºÅÛÀ» °®Ãß¾î¾ß ÇÕ´Ï´Ù. APVS´Â °í°´ÀÇ ¹®¼­°ü¸® Á¤Ã¥°ú ÀýÂ÷¿¡ ´ëÇÑ °³¹ß ¶Ç´Â °ËÅä¿¡ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.
   
ÄÄÇ»ÅÍ ½Ã½ºÅÛµéÀº ÇÁ·Î±×·¥, ÆÄÀÏ, ¶Ç´Â ÀÚ·á¿¡ »ó°ü¾øÀÌ ÀüÀÚ±â·ÏÀ» »ý¼ºÇÕ´Ï´Ù. ÄÄÇ»ÅÍ ½Ã½ºÅÛ¿¡¼­ Á¦°ÅµÈ ÀúÀå¸Åü ¶Ç´Â ¹é¾÷ ±â·ÏµéÀº °ü¸®°¡ ÀÌ·ç¾îÁ®¾ß Çϰí ÀúÀå¸ÅüÀÇ Á¸¼Ó±â°£ÀÌ Á¤ÀÇ µÇ¾î¾ß ÇÕ´Ï´Ù. APVS´Â °í°´ÀÇ ±â·Ïº¸Á¸ Á¤Ã¥°ú ÀýÂ÷ÀÇ °³¹ß°ú °ËÅä¿¡ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.
   
ÄÄÇ»ÅÍ ½Ã½ºÅÛÀÇ °³¹ßÀÚ, »ç¿ëÀÚ, °ü¸®ÀÚµéÀÇ Àû°Ý¼º Áõ¸íÀ» À§ÇÏ¿© ±³À°ÈÆ·Ã ¸ÅÆ®¸¯½º ¹× ±â·ÏµéÀÌ ÀÛ¼ºµÇ°í °ü¸®µÇ¾î¾ß ÇÕ´Ï´Ù. APVS´Â °í°´ÀÇ ±³À°ÈÆ·Ã Á¤Ã¥ ¹× ÀýÂ÷µéÀÇ °³¹ß°ú °ËÅä, ±×¸®°í ±³À°ÈÆ·Ã ¸ÅÆ®¸¯½ºÀÇ °³¹ß¿¡ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.
   
¹ë¸®µ¥ÀÌ¼Ç È°µ¿À» Æ÷ÇÔÇÏ¿©, ½Ã½ºÅÛ, ÇÁ·Î¼¼½º, ±â·Ï, ¹®¼­¿¡ °üÇÏ¿©, »ç¶÷¿¡ ÀÇÇØ ¼öÇàµÈ ¸ðµç Ȱµ¿µéÀº ½ÂÀÎµÈ SOP¿¡ ¹®¼­È­ µÇ¾î¾ß ÇÑ´Ù. SOP´Â ºÒ¸í·áÇÔÀ» ¾ø¾Ö°í ÀϰüµÈ ½ÇÇàÀ» Á¦°øÇÕ´Ï´Ù. APVS´Â °í°´ÀÇ CSV¿Í °ü·ÃµÈ ¸ðµç SOPÀÇ °³¹ß ¹× °ËÅä¿¡ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.

Although CSV is the process of creating documented evidence of following industry standards and complying with regulations, the important thing is to actually follow the industry standards and comply with the regulations. When validating a computer system, the industry standards and regulations for the computer system extend beyond the hardware, software, and supporting documents. The company must show that they have the proper infrastructure and resources to properly operate the system and maintain it. To help your company follow the industry standards and comply with the regulations, some of the regulatory compliance activities that we offer are:

Generally, an early activity in a retrospective validation process, the gap analysis addresses non-compliant and non-validated parts of the system. A summary report will list all of the gaps that have been identified, along with the recommended activities required to bring the system into a compliant and validated status and the estimated costs associated. We can develop an analysis method, execute the analysis, and write the summary report.
 
Companies must conduct periodic reviews and internal audits to verify that its policies and procedures are being followed. Additionally, your company may want a pre-approval inspection of its computer systems, to identify and correct any problems before regulatory agents find them. We can help develop periodic review procedures. We can provide auditing services.
   
Documentation is the end product of all of a company¡¯s validation efforts. Because of this, companies must closely manage the process used to create, review, approve, and store documents. Additionally, they must have a system to index the documents and to secure them from unauthorized people. We can help develop or review your document management policies and procedures.
   
Computer systems create electronic records, whether they are programs, files, or data. These records, once removed from the computer system for storage or backup, must be controlled and the duration of storage must be defined. We can help develop or review your records retention policy and procedures.
   
Training matrices and training records must be created and managed to demonstrate the qualification of developers, users, and administrators for computer systems. We can help develop or review your training policy and procedures. We can help develop your training matrices.
   
All activities carried out by people, with regards to systems, processes, records, and documents, including validation activities, should be documented in approved SOPs. SOPs remove ambiguities and provide for consistent execution. We can help develop or review all of your CSV related SOPs.


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