验证业务和计算机化系统验证

2023-01-06 · 法默康

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验证业务和计算机化系统验证封面图

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由于90%左右的企业在认证检查过程中都存在验证方面的缺陷,且在验证过程中存在的主要问题有:

Since about 90% of enterprises have verification defects in the certification inspection process, and the main problems in the verification process are:

对验证的意义和作用认识不深刻;

The significance and role of verification are not well understood;

如何开展验证过程中的风险评估;

How to carry out risk assessment during validation;

如何通过验证管理加强对产品质量风险的风险控制;

How to strengthen the risk control of product quality risk through verification management;

企业的验证组织不健全;

The verification organization of the enterprise is not sound;

验证的技术手段及控制标准不熟悉;

The technical means and control standards of validation are unfamiliar;

验证过程中的数据如何进行统计分析;

How to conduct statistical analysis on the data in the validation process;

如何进行再验证等等。

How to re verify, etc.

为此,我们公司针对企业存在的这些问题,量体裁衣式为客户推出了专题验证咨询服务系列。验证咨询服务就是将其专业化,根据企业现在在验证过程中所遇到的问题量身定做,发现客户的问题根源所在,对症下药,帮助客户建立一支技术过硬的验证队伍,熟悉并掌握验证相关的相关技术及标准,使客户在验证项目管理上得到一个提升。

To this end, our company has launched a series of special verification consulting services tailored to these problems. The verification consulting service is to professionalize it. It is customized according to the problems encountered by the enterprise in the verification process, to find the root cause of the customer's problems, to suit the remedy to the case, to help the customer establish a skilled verification team, to be familiar with and master the relevant technologies and standards related to verification, so that the customer can improve the management of the verification project.

验证咨询服务内容包括:

Verification consulting services include:

1.培训:提供完善的验证专题培训,包括如何编制URS、SIA\CCA风险评估、各种设备如何验证、检验方法验证培训、清洁验证培训、计算机验证以及工艺验证培训等,具体培训课题可见培训业务板块介绍。

1. Training: provide complete verification training, including how to prepare URS, SIA CCA risk assessment, how to verify various equipment, inspection method verification training, cleaning verification training, computer verification and process verification training. See the introduction of training business section for specific training topics.

2.编制:编制/指导编制URS、SIA\CCA文件以及、各类验证方案/报告等等

2. Preparation: prepare/guide the preparation of URS, SIA CCA documents and various verification schemes/reports, etc

3.实施:实施/指导实施设施设备验证、检验方法验证、清洁验证、计算机验证、工艺验证等

3. Implementation: implement/guide the implementation of facilities and equipment validation, inspection method validation, cleaning validation, computer validation, process validation, etc

验证咨询服务方式:

Verification consulting service mode:

指导式服务:客户与我们相互合作,我们提供方法、理念并指导客户实施,客户接受方法、理念并实施。

Guided service: customers cooperate with us. We provide methods and concepts and guide customers to implement them. Customers accept methods and concepts and implement them.

“交成果”式服务:由我公司服务验证文件的编制,客户按我公司的文件进行实施。

"Deliverable" service: the preparation of service verification documents by our company, and the implementation of the customer according to our company's documents.

以上就是为大家介绍的有关计算机化系统验证公司详细的介绍,希望对您有所帮助.如果您有什么疑问的话,欢迎联系我们.我们将以的态度,为您提供服务https://www.fmkgmp.com

The above is a detailed introduction to the computerized system validation company, and we hope it will be helpful to you. If you have any questions, please contact us. We will provide services for you with our attitude https://www.fmkgmp.com