Software Validation

ServicesComputerized SystemSoftware Validation

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.

Service Advantage

A set of customizable validation documents package complying with regulatory and client requirements (CN/EN/DE)

Professional guidance on CSV execution

Learning of knowledge and experience from CSV consultants


The Software Common Strategies and Services

1. Independent software validation

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:

  • ERP, Enterprise Resource Planning
  • WMS/WCS, Warehouse Management/Control System
  • DMS/QMS, Documentation/Quality Management System
  • MES, Manufacture Execution System
  • LIMS, Laboratory Information Management System

For theabove software system,gempex can provide the related validation. The briefing of the validation strategy isas follow:

  • To ensure thecompliance management of the customized development parts, the correct transfer of data between different systems, and the adequacy and rationality of complex software validation activities.
  • CSV needs to be considered from the overall level. The complex software is usually deployed above the IT infrastructure, and these projects need to consider the qualification of the IT infrastructure.

2. Automation system qualification

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:

  • PCS, Process Control System
  • DCS, Distributed Control System
  • Automated production system: washing-filling-sealing system, liquid preparation-cleaning-sterilization system, freezing-dryer, etc.
  • EMS, Environment Monitoring System
  • BMS,Building Management System
  • Purified Water System/ Water for Injection

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.

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