APVS
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APVS Computer System Validation
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»ç¿ëÀÚ ¿ä±¸»çÇ× ±Ô°Ý¼­(URS), ±â´É ¿ä±¸»çÇ× ±Ô°Ý¼­(FRS), ±×¸®°í »ó¼¼ ¼³°è ±Ô°Ý¼­(DDS)¸¦ Æ÷ÇÔÇÏ¿©, ±Ô°Ý¼­µéÀº »ç¿ëÀÚ¿Í »ê¾÷Ç¥ÁØ ¹× ±ÔÁ¤ ¸ðµÎ¿¡ ´ëÇÏ¿© ¿Ïº®Çϰí Á¤È®ÇØ¾ß ÇÕ´Ï´Ù. APVS´Â °í°´ÀÌ ±Ô°Ý¼­¸¦ °³¹ß ¶Ç´Â ±âÁ¸ ¹®¼­¸¦ °ËÅä Çϴµ¥ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù. ¶ÇÇÑ APVS´Â ȸ°íÀû ¹ë¸®µ¥ÀÌ¼Ç ±¸ÇöÁß¿¡ ½Ã½ºÅÛ¿¡ ´ëÇÑ Àüü ±Ô°Ý¼­¸¦ °³¹ß ÇÒ ¼ö ÀÖ½À´Ï´Ù.
   
½Ã½ºÅÛÀÌ ¿Ï¼ºµÈ ÈÄ¿¡ Part 11 ¿ä±¸»çÇ×À» ÁöŰ·Á´Â ½Ãµµ´Â ¸¹Àº ½Ã°£°ú, Àγ», ±×¸®°í ¸¹Àº ºñ¿ëÀÌ ¼Ò¿äµË´Ï´Ù. Part 11 ¸ñÇ¥Áß¿¡ ÃÖ»óÀÇ °ÍÀ» ¾ò±â À§ÇØ, ÄÄÇöóÀ̾𽺴 ½Ã½ºÅÛÀÇ ¼³°è ½Ã ÀÌ·ç¾îÁ®¾ß ÇÕ´Ï´Ù. APVS´Â °í°´ÀÌ Part 11 ¿ä±¸»çÇ×ÀÇ ¹ø¿ª°ú ±¸ÇöÀ» ÀÌÇØÇϵµ·Ï µµ¿òÀ» µå¸± ¼ö ÀÖ°í, ½Ã½ºÅÛ °³¹ß Ãʱ⿡ ÇÊ¿äÇÑ ±â´É ¹× ǰÁú ¼³°è¿¡ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù. ¶ÇÇÑ APVS´Â °í°´ÀÌ ±âÁ¸ ½Ã½ºÅÛ¿¡ Part 11 ÄÄÇöóÀ̾𽺸¦ ¼³°èÇϴµ¥ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.
   
APVS´Â Á¦¾à»ê¾÷¿¡ À¯¿ëÇÑ ±¤¹üÀ§ÇÏ°í ´Ù¾çÇÑ ¿É¼ÇµéÀ» Àß ¾Ë°í ÀÖÀ¸¸ç, ¿µ¾÷ Ã¥ÀÚ¿¡ Á¦°øµÈ Á¤º¸ÀÌ»óÀ¸·Î ¸¹Àº ½Ã½ºÅ۵鿡 Á¤ÅëÇÕ´Ï´Ù. APVS´Â °í°´ÀÇ Çʿ伺¿¡ ¸Â´Â °¡Àå ÃÖÀûÀÇ ½Ã½ºÅÛÀ» ¼±Á¤ Çϴµ¥ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.
   
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Following industry standards and complying with regulations apply to a computer system at the start of its design phase. Quality assurance should be designed into the system or your company will lose much more time and money trying to correct or adjust for problems after the system is built. We follow Software Development Life Cycle (SDLC) methodologies generally accepted in the software development industry throughout the world. Some of the software development activities that we offer are:

Specifications documents, including the User Requirements Specifications (URS), Functional Requirements Specifications (FRS), and the Detailed Design Specifications (DDS), must be complete and accurate, both with respect to the user and to the industry standards and regulations. We can help you develop your specification documents or provide a review of existing documents. We can also develop entire specification documents for systems during retrospective validation.
 
Trying to comply with Part 11 requirements after a system has been built can be a long, tedious, and expensive task. To gain the most out of Part 11 objectives, compliance should be built into the design of the system. We can help you understand the interpretations and implementations of Part 11 requirements and help you design the necessary functions and quality into your system early in its development. We can also help you design Part 11 compliance into existing systems.
   
We are familiar with a wide variety of options available to the pharmaceutical industry, and understand the systems better than the information provided in sales brochures. We can help you pick the system that best fits your needs.
   
Software development done through an outside contractor and Commercial Off-the-Shelf (COTS) systems require a source code review or a vendor audit to ensure that the system was designed and developed using quality assurance methodologies. We can audit your vendors for quality assurance during software development as defined by a variety of standards.


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