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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
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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.
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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:
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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. |
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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. |
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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. |
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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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