Services

IT management System Establishment

ServicesComputerized SystemIT management System Establishment

The establishment of computerized system documents is used to manage the whole computerized system life cycle. The establishment of good system documents can not only help enterprises strengthen confidence on the official inspections or regular audits, but also help them save the time and cost of system compliance. What’s more, it can bring benefits in risk management, change management, configuration management and data traceability etc. Finally, it provides the maximum support for the production.

gempex provides customers with comprehensive computerized system establishment services. Our experienced experts can provide document written and document review services based on the compliance with GxP regulations. We ensure that those documents are instructive for management and operation of the enterprises.

Service Advantage

Providing a complete set of computerized system documentation (CN/EN/DE)

Practical and convenient of the system documents, easy for daily operation and maintenance

Document design avoiding repetitive work to reduce the enterprise internal workload

advantage

The Service Common Documents

Classification Filename
CS
  • Computerized system management

  • Computerized system risk assessment
  • Computerized system supplier management
  • Computerized system validation management
  • IT infrastructure management
  • Computerized system operation and maintenance management
  • Computerized system business continuity management
  • Computerized system change control procedure
  • Computerized system retirement management
  • Electronic dataand electronic signature management
  • Computerized system security policy
  • Excel sheet management and validation
DI
  • Data lifecycle management
  • Data risk assessment procedure
  • Data integrity

Service Workflow