Software validation of computerized system can be divided into independent software validation and automatic system software validation according to the application scenarios. For the automation system software validation, it refers to the software related to the control of production equipment or utilities system. This part can be carried out by integrating with equipment qualification, or it can be carried out separately.
gempex experts have strong professional background and global project operation experience in software validation. We choose suitable validation strategy by analyzing your system. Finally, gempex deliveries validation package documents which meets your needs and GxP regulations.
A set of customizable validation documents package complying with regulatory and client requirements (CN/EN/DE)
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Here we take the complex software as the example，which normally is used to support customers in completing complex business. Generally, this software belongs to GAMP4 or GAMP5. Therefore, enterprises usually will customize and develop some software functions base on the business requirements. For example:
For theabove software system,gempex can provide the related validation. The briefing of the validation strategy isas follow：
Automation system refers to a system that uses PLC to control the actuator/sensor to achieve business automation. This kind of systemnormally belongsto category 4 or below category 4 (software categorization in GAMP5)and widely uses in pharmaceutical industry. They are often:
For the above automation system,gempex can provide validation service, and the key points of its validation strategy are as follows:
The common points arethe qualification of automatic control logic and action execution. It should be noted that specific validation needs to consider the specific technical implementation of the system, and it may involve the management of customized development activities.
