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SAGE X3 ERP帮助公司遵守FDA合规性要求(上)


Compliance with regulatory requirements is a business-critical need that must be maintained, and the FDA recognizes that a technically advanced software solution can help companies manage compliance.

遵守法规要求是必须维护的关键业务需求,而且FDA认识到技术上先进的软件解决方案可以帮助公司管理合规性。

 

Title 21, Part 11 of the U.S. Food and Drug Administration’s (FDA) Code of Federal Regulations requires drug makers, medical device manufacturers, biotech companies, biologics developers and other FDA-regulated industries (except food manufacturers) to implement controls – including audits, validation systems and documentation – for software and systems involved in processing many forms of data as part of business operations and product development.

美国食品药品监督管理局(FDA)联邦法规21章第11部分要求药品制造商,医疗器械制造商,生物技术公司,生物制剂开发商和其他FDA管制的行业(食品制造商除外)实施控制措施,包括审核, 验证系统和文档用于在业务运营和产品开发过程中处理多种形式数据的软件和系统。

Part 11规定中,电子记录被认为具有与书面记录和手写签名同等的效力,即通过认证的软件,软件信息安全得到了有效的保障。软件在开发层面就要遵守这些认证规定。21 CFR Part 11对系统的安全要求

1.安防措施,21 CFR Part 11对系统的安全要求主要是防止未授权的人进入系统接触电子记录,更改和删除电子记录和电子签名。

2. “许可机制,许可机制确保用户能修改自己的纪录,但只能读(不能修改)其他用户的记录,通过管理个人文件和目录来实现。每个用户根据分配给其不同的权限被设定成一个特定的用户角色(如管理员、主管、技术员、操作员等),也就说定义角色时含分配权限。

3.可信赖记录,可信赖记录的先决条件,除了数据安全性外,就是可追溯性。没有写下来的东西就是谣言FDA检查过程中,审计员将查阅实验室日志来检查分析过程。

日志的内容将不能够用普通的方法被修改或删除。

审核跟踪是确保所有的数据都具有清晰完整的记录,而不是对人员进行控制或衡量工作效率。帮助记录人和复合人理解当时为何要执行特定的操作。

 

The regulation was created to maintain the trustworthiness, reliability and integrity of electronic records and to ensure that the authenticity of electronic records would be equivalent to paper records when submitted. All companies and industries that submit or utilize electronic records and/or signatures regulated by the FDA must comply with this federal regulation.

制定该法规是为了维护电子记录的可信赖性,可靠性和完整性,并确保电子记录的真实性与提交时的纸质记录相同。 提交或使用FDA规定的电子记录或签名的所有公司和行业,必须遵守该联邦法规。

But complying with the regulation proves to be a difficult task for most companies. Since Part 11 was introduced, manufacturers have endured much confusion as the regulation is open to a wide range of interpretations. Despite the confusion surrounding Part 11, one thing remains constant the FDA’s interpretation of the following requirements has not changed – controls for closed and open systems and electronic signatures.

但是,对于大多数公司而言,遵守法规证明是一项艰巨的任务。 自从介绍 第11部分以来,由于该法规对各种各样的解释都开放,因此制造商遭受了很多混乱。 尽管围绕 第11部分存在困惑,但一件事情仍然保持不变,FDA对以下要求的解释没有改变-封闭式和开放式系统以及电子签名的控制。

With that in mind, compliance with regulatory requirements is a business-critical need that must be maintained, and the FDA recognizes that a technically advanced software solution can help companies manage compliance. Specifically, CFR 21 Part 11 states that enterprise resource planning (ERP) systems must provide:
考虑到这一点,遵守法规要求是必须维护的关键业务需求,而且FDA认识到技术上先进的软件解决方案可以帮助公司管理合规性。 具体而言,CFR 21的第11部分规定企业资源计划(ERP)系统必须提供:

       Extensive transaction audit functionality with field, user, time and date reference,

       Document signature printing association for technical or quality assurance generated reports,

       Digital signature to support field and/or screen level security authentication with change reason codes and access verification and historical user, time and date references.

 具有字段,用户,时间和日期参考的广泛事务审计功能,

文档签名印刷,用于生成技术或质量保证报告,

数字签名,支持具有更改原因代码和访问验证以及历史用户,时间和日期参考的字段和/或屏幕级别安全认证。

 

 

Further requirements are associated with the concept of “validation” for both the manufacturer and the software developer. Guidelines require that the company’s needs and intended uses of its selected software system are established and that evidence that the computer system implements those needs correctly are traceable to the system design and specification.

对于制造商和软件开发人员,审核的概念还有其他要求。 准则要求确定公司的需求和所选软件系统的预期用途,并且证明计算机系统正确实现了这些需求的证据可追溯到系统设计和规格。

To help companies adhere to 21 CFR Part 11, Enterprise Management offers the following functionality:

为了帮助公司遵守21 CFR Part 11SAGE X3 ERP提供以下功能:

Audit Trails:Associated with the creation, modification and deletion of electronic records, audit trails are now standard in Enterprise Management. The functionality records user name, date, time, previous data, new data and the reason for the change.

审计跟踪:与电子记录的创建,修改和删除相关,审计跟踪现在已成为X3中的标准。该功能记录用户名,日期,时间,先前数据,新数据以及更改原因。

 

 

Digital Electronic Signatures*:An electronic signature framework includes tables, programs, actions and objects to store, configure and collect unique e-signatures, which are permanently linked to the object and cannot be modified or copied.

数字电子签名*:电子签名框架包括表,程序,操作和对象,用于存储,配置和收集唯一的电子签名,这些电子签名永久链接到该对象,无法修改或复制。

 

 Document Signatures:Documents requiring handwritten signatures, such as Certificates of Analysis or Technical Sheets, are generated with an image linked to the specific document. The image plate is controlled and linked to the user profile.

文档签名:生成需要手写签名的文档,例如分析证书或技术图纸,并带有链接到特定文档的图像。图像受到控制并链接到用户个人资料。

 

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