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1 D. 문서관리 (Document Controls)(Subpart D) 93. One comment stated that subpart D of part 820 should be titled "Document Controls," instead of the proposed "Document and Record Controls" because the "record" requirements are addressed in subpart M. One comment stated that removal of obsolete or unneeded documents should be performed to maintain the integrity of the product configuration and the quality system. The comment suggested adding a requirement for a verification step for document distribution and removal to ensure this important element of a quality system is performed correctly. A few comments stated that proposed Sec should be rewritten to be similar to ISO 9001 and to delete the requirement that documents be "accurate" because the comments feared that typographical errors would be considered violations. 파트 820 서브파트 D의제목을 " 문서및기록서관리 " 대신에 " 문서관리 " 로해야한다는의견이한건있었다. " 기록서 " 기준은서브파트 M에서다루고있기때문이라는것이다. 또한제품구성및품질시스템의완전성유지를위하여유효하지않거나불필요한문서를제거해야한다는의견이한건있었다. 품질시스템의이중요한요소가올바르게수행되도록하기위하여, 문서배포및제거의베리피케이션단계기준을추가하자고주장했다 을 ISO 9001과유사하게다시작성하고, 인쇄오류도위반사항으로간주될수있기때문에문서가 " 정확 " 해야한다는기준은삭제하자는의견이있었다. FDA agrees with the first comment and has changed the title accordingly. FDA agrees in part with the second comment. The verification of document distribution and removal is very important and can directly affect the quality of a product. Section , which requires that the manufacturer establish and maintain procedures to control all documents, including those that are obsolete and/or to be removed, requires that the removal (or prevention of use) of obsolete documents be verified. FDA agrees in part with the last set of comments and has rewritten the section, following ISO 9001:1994, to be a general requirement for procedures to control documents that are required under the regulation. The procedures established must, among other things, ensure control of the accuracy and usage of current versions of the documents and the removal or prevention from use of obsolete documents, as well as ensure that the documentation developed is adequate to fulfill its intended purpose or requirement. FDA retained the requirement that the procedures ensure that documents meet the requirements of 1

2 the regulation because that is the purpose of controlling the documents. FDA deleted the term "accurate" but notes that a typographical error can change the meaning of a document and have undesirable consequences. 첫번째의견에동의하여제목을수정했다. 두번째의견에는부분적으로동의한다. 문서배포및제거의베리피케이션은매우중요하며제품품질에직접적인영향을줄수있다. 유효하지않은문서및 / 또는제거예정문서를포함하여, 모든문서의관리절차를제조업체가확립하고유지하도록한섹션 은, 유효하지않은문서의제거 ( 또는사용방지 ) 를베리피케이션해야한다고요구한다. 마지막의견에는부분적으로동의하며, 이규정에서요구되는문서의관리절차에대한일반기준이되도록, ISO 9001:1994에따라이섹션을다시작성했다. 무엇보다도확립된절차는최신버전의문서사용과정확성또는유효하지않은문서의사용방지를보장하고, 개발된문서가예정목적이나기준이행에적절하도록해야한다. 문서가이규정의기준을충족하도록보증하는절차에관한기준은그대로유지했다. 그것이문서관리의목적이기때문이다. 한편 " 정확한 " 이란단어는삭제했다. 하지만인쇄오류는문서의의미를변화시킬수있으며, 그에따라바람직하지않은결과로이어질수있음은인식할필요가있다. 94. Several comments on proposed Sec (a), "Document approval and issue," as well as other sections throughout the regulation, suggested that the term "signature" be replaced by the term "identification." Such a change would allow for electronic or computerized identification in lieu of formal written signatures. Other comments stated that "or stamps" should be added after "signature" since they are legally recognized in some foreign countries (a) " 문서승인및발행 " 과이규정의다른섹션과관련하여, " 서명 " 을 " 확인 " 으로대체해야한다는의견이있었다. 그렇게변경하면, 공식수기서명대신에전자적또는컴퓨터화식별방법을사용할수있다는것이다. 또한 " 또는도장 " 을 " 서명 " 뒤에추가해야한다는의견이있었다. 일부외국에서는도장이법적으로인정되기때문이라는것이다. FDA is aware that many documentation systems are now maintained electronically, and is in the process of developing an agency-wide policy that will be implemented through rulemaking on the use of electronic signatures. The agency identified several important issues related to the use of such signatures, including how to ensure that the identification is in fact the user's "signature." These issues are discussed in FDA's ANPRM on the use of electronic signatures, published in the Federal Register on July 21, 1992 (57 FR 32185), and the proposed regulation 2

3 published in the Federal Register on August 31, 1994 (59 FR 45160). Therefore, FDA has not revised the regulation to use the term "identification," but notes that the quality system regulation's use of the term "signature" will permit the use of whatever electronic means the agency determines is the equivalent of a handwritten signature. FDA recommends that manufacturers use the two Federal Register documents as guidance until the regulation is finalized. FDA has not added the term "or stamps" to the regulation; however, stamps could be acceptable if the manufacturer has a formal procedure on how stamps are used in place of handwritten signatures. The procedure would have to address many of the same issues addressed in the electronic signature Federal Register documents, most importantly how the stamps would be controlled and how the manufacturer would ensure that the stamp was in fact the user's "signature." 많은문서시스템이현재전자적으로운영되고있음을알고있으며, FDA 역시전자서명의사용에관한규칙을통하여 FDA 전체차원의방침을개발해추진하는작업을진행하고있다. 그와같은서명의사용과관련하여, 확인이실제사용자의 " 서명 " 임을보증하는방법을포함해, 몇가지중요한이슈가제기되었다. 이들이슈는 1992년 7월 21일자연방관보 (57 FR 32185) 에게재된전자서명의사용에관한 ANPRM과 1994년 8월 31일자연방관보 (59 FR 45160) 에게재된규정안에서다루고있다. 그러므로 " 확인 " 이란표현을사용하지않았으며, 품질시스템규정에서 " 서명 " 이란용어를사용한다고해도수기서명에해당되는것이라고 FDA가판단하는전자적인수단의사용도허용할것이다. 이규정이마무리되어확정될때까지, 연방관보의 2개문서를가이드라인으로활용할것을권고한다. " 또는도장 " 이란표현을추가하지않았다. 하지만수기서명대신에도장의사용방식에관한공식절차를갖추고있다면도장도허용가능하다. 전자서명관련연방관보문서에서다룬것과동일한이슈를이절차문서에서다루어야할것이며, 특히도장의관리방법과도장이실제로사용자의 " 서명 " 임을보증하는방법이포함되어야한다. 95. Several comments stated that proposed Sec (b), "Document distribution," should be rewritten to be consistent with ISO (b) " 문서배포 " 는 ISO 9001 에맞추어다시작성해야한다는의견이많았다. In response, FDA has deleted the section. The requirements for making documents available at all appropriate locations (ISO 9001:1994, section 4.5.2(a)) and the requirements for promptly removing obsolete documents (ISO 9001:1994, section 4.5.2(b)) have been moved, in revised form, to Sec (a). In response to 3

4 comments, FDA has added that obsolete documents, in lieu of being promptly removed from points of use, may be "otherwise prevented from unintended use." 이에따라이섹션을삭제했다. 문서를모든관련장소에서활용할수있게해야한다는기준 (ISO 9001:1994 섹션 4.5.2(a)) 과유효하지않은문서는즉시제거해야한다는기준 (ISO 9001:1994 섹션 4.5.2(b)) 은 (a) 로옮겼다. 또한의견을반영하여유효하지않은문서를사용지점에서즉시제거해야한다는표현대신에, " 의도하지않은사용을방지 " 하도록했다. 96. Several comments suggested major changes to proposed Sec (c), "Documentation changes." Some stated that the requirements should be revised to be consistent with ISO Others stated that the requirements related to validation should be rewritten and moved to another section under this part, because Sec (c) should only address document changes, not device changes. Several comments stated that the reference to determining whether a 510(k) or PMA supplement is required after making changes to a device should be deleted because it is covered under different parts of the act and regulations. One comment stated that the requirement in Sec (c) for changes to be "approved by individuals in the same functions/organizations that performed the original review and approval, unless specifically designated otherwise" is unrealistic and does not reflect the way things are done in real life (c) " 문서변경 " 의대대적인변경을요구한의견이다수있었다. ISO 9001에맞추어이기준을수정해야한다는의견도있었고, 밸리데이션과관련된기준은다시작성하여이파트의다른섹션으로옮겨야한다는의견도있었다 (c) 는의료용구변경이아니라문서변경만을다루어야하기때문이라는것이다. 또한의료용구변경이후에 510(k) 또는 PMA 보완서류제출이필요한지여부의결정과관련된부분은, 법과규정의다른부분에서다루고있기때문에삭제해야한다는의견도많았다. 이외에도 " 달리지정된경우가아니라면, 처음에검토와승인을실시했던기능 / 조직의사람이변경사안을승인 " 하도록한 (c) 의기준은현실적이지않으며실제업무수행방식을반영하고있지않다는의견이있었다. FDA agrees with many of the comments and has substantially rewritten Sec (c), now designated as Sec (b), to relate specifically to changes to a document. The requirements are now very similar to the ISO 9001:1994 requirements in section FDA has retained the requirement that the approved 4

5 changes must be communicated in a timely manner to appropriate personnel. FDA has had many experiences where manufacturers made corrections to documents, but the changes were not communicated in a timely manner to the personnel utilizing the documents. The result of these untimely communications was the production of defective devices. 많은의견에동의하며 (c) 를다시작성하여 ( 이제는 (b) 로변경 ), 구체적으로문서에관한변경만을다루게했다. 이제는 ISO 9001:1994 섹션 4.5.3의기준과매우유사하다. 승인된변경사안은적절한작업자에게적시에전달해야하다는기준은그대로유지했다. 문서를수정하면서도변경사안을해당문서의사용자에게적시에전달하지않은사례를많이경험했다. 이와같은적시커뮤니케이션부재의결과로결함의료용구가생산되었다. In addition, FDA has moved the requirement for validating production and process changes to Sec (b), "Production and process changes," and notes that changes to the design specifications, at any time during the lifetime of the design of the device, must conform to the requirements in Sec (i), "Design changes." 이외에도생산및공정변경밸리데이션기준은 (b) " 생산및공정변경 " 으로옮겼고, 의료용구의디자인과정에서언제라도발생하는디자인규격변경은 (i) " 디자인변경 " 의기준에부합해야한다는점을강조한다. FDA has also deleted the sentence referencing 510(k)'s and PMA supplements because FDA believes this is covered elsewhere, but notes that this sentence is in the preamble above for Sec (i). 또한 510(k) 및 PMA 보완서류관련부분은다른곳에서다루고있기때문에삭제했다. 하지만이문장은상기전문의 (i) 에관한부분에있다. FDA disagrees that the requirement for changes to be "approved by an individual(s) in the same function or organization that performed the original review and approval, unless specifically designated otherwise" should be deleted and notes that this is a requirement of ISO 9001:1994 as well. The intent of the requirement is to ensure that those who originally approved the document have an opportunity to review any changes because these individuals typically have the best insight on the impact of the changes. The requirement is flexible, however, because it permits the manufacturer to specifically designate individuals who did not perform the original review and approval to review and approve the changes. To designate such 5

6 individuals, the manufacturer will need to determine who would be best suited to perform the function, thus ensuring adequate control over the changes. In this way, review and approval will not be haphazard. " 달리지정된경우가아니라면, 처음에검토와승인을실시했던기능 / 조직의사람이변경사안을승인 " 하도록한기준을삭제해야한다는의견에는동의하지않으며, 이부분은 ISO 9001:1994의기준이기도하다. 이기준의취지는, 처음에문서를승인했던자가모든변경의검토기회를가져야한다는데있다. 이런사람이그변경의파급효과를가장잘알수있기때문이다. 하지만이기준은최초검토및승인을수행하지않은자가변경사안의검토및승인을수행하도록지정할수있게허용하고있으므로, 이기준은유연성을갖고있다. 그런사람을지정하려면, 제조업체는그업무의수행에가장적합하며, 그에따라변경의적절한관리가보장될수있는자를정할필요가있다. 이런식으로하면, 검토와승인이무계획적으로진행되지않을것이다. 97. One comment on proposed Sec (d), "Documentation change record," stated that this section should be deleted because the other paragraphs of Sec adequately cover the proposed requirements. Two comments suggested replacing the section with the requirements of section of ISO (d) " 문서변경기록서 " 와관련하여, 의다른구절에서이기준을적절하게다루고있으므로, 이섹션을삭제해야한다는의견이한건있었다. 이섹션은 ISO 9001의섹션 기준으로대체하자는의견이두건있었다. FDA has deleted Sec (d) and placed the revised requirements in paragraphs (a) and (b) of this section. The general requirement of Sec now requires the manufacturer to establish adequate procedures to control all documents required by part 820. The procedures must cover the requirements listed in Sec (a) and (b). Thus, the manufacturer must establish a procedure for ensuring that only the current and approved version of a document is used, achieving the objective of the "Master list or equivalent document control procedure," required in ISO 9001:1994, section (d) 를삭제하고수정기준을이섹션의 (a) 및 (b) 에배치했다. 현재 인이기준은, 제조업체가파트 820에서요구하는모든문서를관리하는적절한절차를확립하도록요구하고있다. 이절차는 (a) 및 (b) 의기준을포괄해야한다. 그러므로제조업체는현재의승인된문서만이사용되고, 그리하여 ISO 9001:1994 섹션 4.5.2의 " 마스터목록또는그에상응하는문서관리절차 " 의목표를달성할수있는 6

7 절차를확립해야한다. The other requirement in Sec (d), "Document change record," was to maintain a record of changes, to include a description of the changes, among other things. FDA has retained this requirement and has moved it into Sec (b), "Document changes," because the agency believes this information to be important and useful when investigating and performing corrective or preventive actions (d) " 문서관리기록서 " 의다른기준은, 무엇보다도변경에대한설명을포함하여, 변경기록서를유지하기위한것이었다. 이기준을유지하되, (b) " 문서변경 " 으로위치를옮겼다. 조사를실시하고시정조치또는예방적조치를수행하는데이정보가중요하고유용하다고보기때문이다. FDA believes Sec on Document controls now adequately harmonizes with ISO 9001:1994, sections 4.5.1, 4.5.2, and " 문서관리 " 는이제 ISO 900:1994 섹션 4.5.1, 4.5.2, 4.5.3과적절하게조화를이룬다고믿는다. 7

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