06-FDA指南-制药CGMP法规的质量系统方法

etheauthorityandresponsibilitytomobilizeresources高级管理层-企业内的最高管理人员,具有调动资源的权利和责任。anizationhavinganownershiporinterestinthedelivery,results,andmetricsofthequalitysystemframeworkorbusinessprocessimprovements股东-在质量系统框架或业务过程改进的传输、结果和衡量标准上拥有所有者权益或利益的个人或组织Verification-Confirmation,throughtheprovisionofobjectiveevidence,thatspecifiedrdrequirementshavebeenfulfilled・(Reference:TheASQAuditingHandbook,3edition,ASQQualityAuditDivision,J.P.Russell,Editor)确认-提供客观证据,证明已经达到规定的要求。(参考:ASQ审计手册,第3版,ASQ质量审计处,J.P.Russell,主编)Validation一Confirmation,throughtheprovisionofobjectiveevidence,thattherequirementsforaspecificintendeduseorapplicationhavebeenfulfilled.(Reference:TheASQAuditingrdHandbook,3edition,ASQQualityAuditDivision,J.P.Russell,Editor)验证・提供客观证据,证明已经达到特定用途或应用的要求。(参考资料:ASQ审计手册,第3版,ASQ质量审计处,J.P.Russell,编辑)。