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CSV´Â ³Î¸® Åë¿ëµÇ´Â ¹æ½ÄÀÔ´Ï´Ù. ±×·¯¹Ç·Î, CSV ±¸Çö¿¡´Â ³Ð°í ´Ù¾çÇÑ ¹æ¹ý·ÐÀÌ ÀÖ½À´Ï´Ù. ¹Ì±¹ ÀǾàǰ ¹ë¸®µ¥ÀÌ¼Ç »ê¾÷¿¡¼ÀÇ °æÇè°ú ´õºÒ¾î,
APVS´Â »ê¾÷ Àü¹Ý¿¡ °ÉÃļ ³Î¸® ½ÂÀÎµÈ ¹æ½ÄÀ» ȸ»çÀÇ °ßÇØ¿Í ¹æ¹ý·Ð¿¡ Á¢¸ñ½Ãų ÃÖ»óÀÇ ¹æ¹ýÀ» ¾Ë°í ÀÖ½À´Ï´Ù. ´ÙÀ½Àº APVS°¡ Á¦°øÇÏ´Â CSV
Ȱµ¿ÁßÀÇ ÀϺΠÀÔ´Ï´Ù.
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MVP´Â ¿©·¯ °³ÀÇ ½Ã½ºÅÛµéÀÌ Æ÷ÇÔµÈ ÇÁ·ÎÁ§Æ® ¶Ç´Â ½Ã½ºÅÛ¿¡ ´ëÇÑ ¹ë¸®µ¥ÀÌ¼Ç ±¸Çö¹æ¹ýÀ» »ó¼¼È÷ ¼³¸í ÇÕ´Ï´Ù. MVPÀÇ ¸ñÀûÀº ½Ã½ºÅÛ °ËÁõ,
°ËÁõµÈ »óÅÂÀ¯Áö, Æó±â¿¡ ÇÊ¿äÇÑ ¼ÒÇÁÆ®¿þ¾î °³¹ß ¹æ¹ý·Ð ¹× ÀýÂ÷, ±×¸®°í ½Ã½ºÅÛÀÇ °³¹ß, ±¸Çö, ¹ë¸®µ¥ÀÌ¼Ç ÀÏÁ¤À» Æ÷ÇÔÇÏ¿©, ¹ë¸®µ¥À̼ÇÀÇ
Àü¹ÝÀûÀÎ ¶óÀÌÇÁ»çÀÌŬ Àü·«ÀÇ ¹®¼È ÀÔ´Ï´Ù. ´õ¿íÀÌ, MVP´Â °ËÁõÇØ¾ß ÇÒ ½Ã½ºÅÛ ±â´É¿¡ °üÇÑ ¼³¸í ¹× °ü·Ã ¸ðµç ºÎ¼ÀÇ ¿ªÇÒ ¹× Ã¥ÀÓÀ»
±â¼úÇÕ´Ï´Ù. APVS´Â °í°´ÀÇ MVP °³¹ß ¹× °ËÅä¿¡ µµ¿òÀ» µå¸± ¼ö ÀÖ½À´Ï´Ù.
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Àû°Ý¼º ÇÁ·ÎÅäÄÝÀº ½Ã½ºÅÛ »ç¿ëÀ» À§ÇÑ ¹èÆ÷¿¡ ¾Õ¼¼ ÄÄÇ»ÅÍ ½Ã½ºÅÛÀÇ ¿Ã¹Ù¸¥ ¼³Ä¡ ¹× ¿î¿µ ¹®¼¸¦ ¸¸µå´Â °ÍÀÔ´Ï´Ù. ÀϹÝÀûÀ¸·Î Çã¿ëµÇ´Â
Àû°Ý¼º ¹®¼µé¿¡´Â ¼³Ä¡Àû°Ý¼º(IQ), ¿î¿µÀû°Ý¼º(OQ), ±×¸®°í ¼º´ÉÀû°Ý¼º(PQ) µîÀÌ Æ÷ÇԵ˴ϴÙ. ±×·¯³ª ½Ã½ºÅÛÀÇ ¹æ¹ý·Ð ¹× º¹À⼺¿¡ µû¶ó,
ÀÌ·¯ÇÑ ¹®¼µéÀÇ Áö¿ø ¹× ±³Ã¼¸¦ À§ÇÑ ´Ù¸¥ ¹®¼µéÀÌ °³¹ßµÉ ¼öµµ ÀÖ½À´Ï´Ù. APVS´Â °í°´ÀÇ Á¤Ã¥, MVP, ±×¸®°í ½Ã½ºÅÛÀÇ º¹À⼺À» ±â¹ÝÀ¸·Î
¹®¼È ¹× Å×½ºÆ®¿¡ ÇÊ¿äÇÑ °¡Àå È¿°úÀûÀÎ ¹æ¹ýÀÇ °áÁ¤À» µµ¿Íµå¸± ¼ö ÀÖ½À´Ï´Ù. ¶ÇÇÑ APVS´Â Å×½ºÆ® ¼öÇà ¹× °ü¸® ±×¸®°í ¿ä¾à º¸°í¼¸¦
ÀÛ¼ºÇÒ ¼ö ÀÖ½À´Ï´Ù.
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ȸ°íÀû ¹ë¸®µ¥À̼ÇÀº ±âÁ¸¿¡ »ç¿ëÁßÀÎ ½Ã½ºÅÛÀ» °ËÁõÇÏ´Â ÇÁ·Î¼¼½º ÀÔ´Ï´Ù. ȸ°íÀû ¹ë¸®µ¥À̼ÇÀº °ËÁõ ÀÛ¾÷À» ¼öÇàÇÏÁö ¾Ê¾Ò°í, °ËÁõµÈ
»óÅ·ΠÀ¯ÁöµÇÁö ¾Ê¾Ò°Å³ª, ÀϺΠÁß¿äÇÑ ¹æ½ÄÀÌ º¯°æµÈ ½Ã½ºÅÛ¿¡ ÇÊ¿äÇÕ´Ï´Ù. ½Ã½ºÅÛ¿¡ ´ëÇÑ È¸°íÀû ¹ë¸®µ¥À̼ÇÀÇ ¸ñÀûÀº ¿¹ÃøÀû ¹ë¸®µ¥À̼ǰú
µ¿ÀÏÇÏÁö¸¸, ¸ñÇ¥ ´Þ¼ºÀ» À§ÇÑ ¹æ¹ýÀº ¹ë¸®µ¥ÀÌ¼Ç ¹æ¹ý·Ð, ½Ã½ºÅÛÀÇ º¹À⼺, ½Ã½ºÅÛ °ËÁõ¿¡ ÇÊ¿äÇÑ È°µ¿¿¡ µû¶ó ´Ù¾çÇÕ´Ï´Ù. APVS´Â °í°´À»
À§ÇØ Àç½ÃÇè ¹× ¹®¼°ËÅä, ¼öÁ¤, °³¹ß µîÀ» Æ÷ÇÔÇÏ¿©, CSV¿Í °ü·ÃµÈ ¸ðµç ȸ°íÀû ¹ë¸®µ¥ÀÌ¼Ç È°µ¿À» ¼öÇàÇÒ ¼ö ÀÖ½À´Ï´Ù.
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½Ã½ºÅÛÀÌ »ý¼ºÇÏ´Â ÀüÀÚ±â·Ï ¶§¹®¿¡ ÄÄÇ»ÅÍ ½Ã½ºÅÛ ¹ë¸®µ¥À̼ǿ¡ ³»¿¡¼ ½Ã½ºÅÛ Æó±â´Â ¾ÆÁÖ Áß¿äÇÕ´Ï´Ù. ½Ã½ºÅÛ¿¡ »ý¼ºµÇ°í ÀúÀåµÈ ÀüÀÚ±â·ÏÀÇ
À¯Çü ¼³¸í, ´Ù¸¥ ½Ã½ºÅÛ ¶Ç´Â ÀúÀå¸Åü¿¡ ÀڷḦ ÀÌÀüÇÏ´Â ¹æ¹ý, ±×¸®°í Æó±âµÈ ½Ã½ºÅÛÀÌ ¾øÀ» °æ¿ì ÀÌÀü¿¡ »ý¼ºµÈ ±â·ÏµéÀ» º¹±¸ÇÏ´Â ¹æ¹ýµéÀ»
¼³¸íÇϱâ À§ÇÏ¿© ½Ã½ºÅÛ Æó±âÀÇ °æ¿ì °èȹÀÌ ÇÊ¿äÇÕ´Ï´Ù. APVS´Â ½Ã½ºÅÛ Æó±â °èȹ ¹× ÀÚ·á ÀÌÀü °èȹÀ» °³¹ß ¶Ç´Â °ËÅäÇÒ ¼ö ÀÖ°í, ¿ä¾à
º¸°í¼¸¦ ÀÛ¼ºÇÒ ¼ö ÀÖ½À´Ï´Ù.
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21 CFR Part 11(Part 11) Áؼö Å×½ºÆ®´Â U.S, FDA°¡ ¹ßÇ¥ÇÑ Part 11ÀÇ ¿ä±¸»çÇ׿¡ µû¶ó ÀüÀÚ±â·Ï ¹× ÀüÀÚ¼¸í °ü¸®¸¦ À§ÇÑ ÄÄÇ»ÅÍ ½Ã½ºÅÛ
Å×½ºÆ®¸¦ Æ÷ÇÔ ÇÕ´Ï´Ù. ÄÄÇ»ÅÍ ½Ã½ºÅÛ¿¡ ÀÇÇØ »ý¼º, ¼öÁ¤, À¯Áö, ÀúÀå, °Ë»ö, ¶Ç´Â ¹èÆ÷µÇ´Â ÀüÀÚ±â·Ï ¹× ÀüÀÚ¼¸í¿¡ ´ëÇÑ °ü¸®º¸ÁõÀº Ưº°È÷
°í°´ÀÇ ½Ã½ºÅÛ¿¡ Part 11ÀÇ Àû¿ë¿©ºÎ¿Í °ü°è¾øÀÌ, ½Ã½ºÅÛÀÇ °ü¸® º¸Áõ¿¡ °üÇÑ Áß¿äÇÑ ºÎºÐ ÀÔ´Ï´Ù. APVS´Â ¹ë¸®µ¥ÀÌ¼Ç ÇÁ·ÎÅäÄÝ °³¹ß, Å×½ºÆ®
¼öÇà, Part 11 Áؼö¸¦ Áõ¸íÇÒ ¼ö ÀÖ´Â ¿ä¾à º¸°í¼¸¦ ÀÛ¼ºÇÒ ¼ö ÀÖ½À´Ï´Ù.
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¿¹»óÄ¡ ¸øÇß´ø ¸ðµç ÇÁ·ÎÅäÄÝ Å×½ºÆ® °á°úµéÀº, ÀÌÅ» ÇØ°á ¹æ¾ÈÀ» ÅëÇÏ¿© Á¶»ç°¡ ÀÌ·ç¾î Áö°í ÇØ°áµÇ¾î¾ß ÇÕ´Ï´Ù. ÀÌÅ» ÇØ°á¹æ¾ÈÀº
À§ÇèÆò°¡¸¦ Æ÷ÇÔÇϰí, ½Ã½ºÅÛ¿¡ ´ëÇÑ º¯°æ, Àç½ÃÇè, ±×¸®°í °ü·Ã ¹®¼¸¦ º¯°æÇÏ´Â °á°ú¸¦ °¡Á®¿Ã ¼ö ÀÖ½À´Ï´Ù. APVS´Â ÀÌÅ»ºÐ¼®,
À§ÇèÆò°¡, Ãæ°ÝºÐ¼®, Àç½ÃÇè, ±×¸®°í ¹®¼¼öÁ¤À» Áö¿øÇÒ ¼ö ÀÖ½À´Ï´Ù.
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CSV is a widely interpreted practice. Therefore, there is a wide variety of methodologies that exist to implement CSV. With our
experience in the U.S. pharmaceutical validation industry, we know how best to match the generally accepted practices of the industry
to the beliefs and methodologies of your company. Some of the CSV activities that we offer are:
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The MVP details the validation approach for a system or a project including several systems. The purpose of the MVP is to document
the overall life cycle strategy of the validation, including a software development methodology, procedures that will be required
to validate the systems, to keep it validated, and to retire it, and a schedule of the development, implementation, and validation
of the systems. Additionally, the MVP will describe the roles and responsibilities of all of the parties involved and a description
of the functionality of the systems that will be validated. We can help develop or review your Master Validation Plan.
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Qualification protocols document the proper installation and operation of a computer system prior to releasing the system for use.
Generally accepted qualification documents include Installation Qualification (IQ), Operational Qualification (OQ), and Performance
Qualification (PQ). However, depending upon the methodology and the complexity of the system, other documents may be developed to
support or replace these documents. We can help determine the best level of required documentation and testing based on your policies,
MVP, and the complexity of your system. We can also execute the testing or manage the testing and write a summary report.
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Retrospective validation is the process of validating a system that is already in use. Retrospective validation may be required for
systems that have never been validated, have not maintained their validated status, or have changed in some significant manner.
The goals of retrospective validation for computer systems are the same as a prospective validation, but the methods to achieve the
goal will vary depending upon the validation methodology, the complexity of the system, and the activities required to validate the
system. We can perform all CSV related retrospective validation activities for you, including retesting and documentation review,
update, and development.
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System retirement is particularly important for Computer System Validation because of the electronic records that the system creates.
System retirement requires a plan that describes the type of electronic records created or stored by the system, a method of migrating
the data to another system or into storage, and a method of restoring previously created records in the absence of the retired system.
We can develop or view the Retirement Plan and Data Migration Plan. We can also develop the Retirement Protocol, execute any required
testing, and write a summary report.
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21 CFR Part 11 (Part 11) compliance testing involves testing a computer system for its control over its electronic records and electronic
signatures in accordance with the requirements of Part 11 set forth by the U.S. FDA. Ensuring control over the electronic records and
electronic signatures created, modified, maintained, archived, retrieved, or distributed by a computer system is an important part of
ensuring control over your computer system, regardless of whether Part 11 specifically applies to your system. We can develop validation
protocols, execute the testing, and write a summary report to demonstrate Part 11 compliance.
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Any protocol test result that was not expected, must be investigated and resolved through a deviation resolution. Deviation resolutions
involve risk assessments and may result in changes to the system, retesting, and changes to associated documentation. We can assist
in deviation analysis, risk assessment, impact analysis, retesting, and updating documentation.
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