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符合药监三类医疗器械新规定的眼镜店软件有哪些?

符合药监三类医疗器械新规定的眼镜店软件有哪些?

这两年开眼镜店的朋友都知道,药监对隐形眼镜这类医疗器械的监管越来越严了。以前卖隐形眼镜可能没太多讲究,但现在完全不同了——隐形眼镜被明确划入第三类医疗器械,风险等级最高,监管也是最严格的。

具体严到什么程度?新修订的《医疗器械经营质量管理规范》已经正式施行,里面明确要求:凡是经营第三类医疗器械的眼镜店,必须配备一套符合管理要求的计算机信息系统,要能全程追溯产品从进货到卖出的每一个环节。说得直白一点,卖隐形眼镜的店如果没有一套合规的管理软件,药监来检查的时候就可能出大问题。而且这套软件也不是随便找个进销存系统就行的,它得能记录每个产品的批号、有效期、生产厂家、供货商,还要能自动提醒快到期的产品,甚至能自动锁定过期产品不让卖。

再加上现在药监部门对眼镜店的检查越来越频繁,从资质审核到销售记录、从库存管理到质量追溯,每个环节都要留痕可查。对眼镜店老板来说,这不是“要不要用软件”的问题,而是“不用软件可能就过不了检查、拿不到证”的问题。

合规管理软件推荐:傲蓝悦视星眼镜店软件

面对这样的新形势,市面上有没有专门针对药监新规开发的眼镜店软件呢?有的。目前比较受行业认可的是傲蓝悦视星眼镜店软件。这款软件就是冲着新修订的《医疗器械经营质量管理规范》去做功能升级的,整个软件的设计都严格遵循了国家三类医疗器械的法规要求。

符合药监要求的傲蓝悦视星眼镜店软件

简单来说,这套系统把眼镜店日常经营需要做的事——采购进货、库存管理、销售开单、会员管理、数据报表——全都串在了一起,而且每一步都嵌入了合规检查的机制。比如进货的时候要验供应商资质,卖的时候要记录顾客信息和产品信息,库存里快到期的产品会自动提醒,确保眼镜店在合规的路上不出岔子。

几个核心功能,帮你吃透合规要求

说了这么多,傲蓝悦视星到底凭什么能帮眼镜店通过药监检查?下面挑几个最实用的功能跟大家聊聊。

采购管理这块,软件新增了供应商资质审核和质量追溯功能。每批货进来的时候,系统会自动核验供应商的证件是不是有效,产品有没有合法的注册证号。所有产品的流转信息从源头到终端都清清楚楚,一旦需要追溯,随时可以查。

库存管理更是关键。隐形眼镜这类产品最怕的就是过期了还在卖。傲蓝悦视星能实时监控每件产品的有效期,快到期的会提前发出预警,一旦产品过期,系统会自动锁定,想卖也卖不出去,从根本上杜绝了违规销售的风险。同时,每个隐形眼镜的批号、生产日期、有效期、生产厂家等信息都能全面记录,支持扫码批量入库,大大减少了人工录入的错误。

符合药监要求的傲蓝悦视星眼镜店APP

销售管理方面,系统会强制关联顾客的验光数据,避免超度数销售。每一笔销售记录都会自动保存产品信息和顾客信息,形成了完整的销售档案,药监来检查的时候,所有数据一目了然。

此外,软件还提供了数据报表功能,老板可以通过直观的图表随时掌握门店的经营状况,连锁店的管理也能轻松搞定。

问与答

问:我的眼镜店只卖普通镜架和镜片,不卖隐形眼镜,需要这种软件吗?

答:如果你的店里完全不涉及隐形眼镜、角膜塑形镜这些第三类医疗器械,那对这套软件的需求就没那么急迫。但想提高经营管理的话,还是建议使用傲蓝悦视星眼镜店软件。这软件除了适合药监要求外,还是一款专门为眼镜行业打造的管理系统软件。

问:用了傲蓝悦视星,药监来检查就能直接通过吗?

答:用合规的软件只是通过了“信息系统”这一项要求。药监检查还涉及人员资质、经营场所、管理制度等多个方面。但软件能帮你把最关键的产品追溯和销售记录这一关解决好,让检查时拿得出完整的数据和台账。很多视光中心和眼镜店反馈,这款软件已经通过了全国各地的药监检查。

问:这个软件操作难不难?我店里的员工年纪偏大,怕学不会。

答:傲蓝悦视星在用户体验上下了不少功夫,界面设计比较简洁明了,操作流程也很人性化,即便没有专业背景的店员也能很快上手。而且软件提供培训支持,上手并不难。

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  1. CONNECT:[ UseTime:0.000575s ] mysql:host=127.0.0.1;port=3306;dbname=wenku;charset=utf8mb4
  2. SHOW FULL COLUMNS FROM `fenlei` [ RunTime:0.001168s ]
  3. SELECT * FROM `fenlei` WHERE `fid` = 0 [ RunTime:0.000367s ]
  4. SELECT * FROM `fenlei` WHERE `fid` = 63 [ RunTime:0.000303s ]
  5. SHOW FULL COLUMNS FROM `set` [ RunTime:0.000727s ]
  6. SELECT * FROM `set` [ RunTime:0.000259s ]
  7. SHOW FULL COLUMNS FROM `article` [ RunTime:0.000787s ]
  8. SELECT * FROM `article` WHERE `id` = 528636 LIMIT 1 [ RunTime:0.000503s ]
  9. UPDATE `article` SET `lasttime` = 1776185692 WHERE `id` = 528636 [ RunTime:0.004435s ]
  10. SELECT * FROM `fenlei` WHERE `id` = 64 LIMIT 1 [ RunTime:0.004754s ]
  11. SELECT * FROM `article` WHERE `id` < 528636 ORDER BY `id` DESC LIMIT 1 [ RunTime:0.001222s ]
  12. SELECT * FROM `article` WHERE `id` > 528636 ORDER BY `id` ASC LIMIT 1 [ RunTime:0.000533s ]
  13. SELECT * FROM `article` WHERE `id` < 528636 ORDER BY `id` DESC LIMIT 10 [ RunTime:0.001609s ]
  14. SELECT * FROM `article` WHERE `id` < 528636 ORDER BY `id` DESC LIMIT 10,10 [ RunTime:0.002017s ]
  15. SELECT * FROM `article` WHERE `id` < 528636 ORDER BY `id` DESC LIMIT 20,10 [ RunTime:0.002868s ]
0.120472s