Validation, operations and management of change

Validation, operations and management of change 281 At the end of the work in this phase complete the following checklist ... 

The laboratory ensures that the processes that are used for the performance of the analysis operate within defined limits and that the equipment used for the performance of such processes are approved and the persoimel using this equipment are qualified. The operation of the laboratory activity is based on the use of specific methods and procedures. Objective evidence that the whole laboratory activity is under control is supported by the relevant records that the laboratory keeps and manages. Processes shall be re-validated from time to time as well as after the occiurence of any changes that might affect the process. 

There should be written procedures to establish systems to manage and control changes that may impact the development, validation, or implementation or affect the maintenance of a validated state for computer systems. Such procedures and controls should apply to all GXP operations and all the systems that support GXP operations. 

The Validation Report authorizing use of the computer system should not be issued until all operation and maintenance requirements, including document management, calibration, maintenance, change control, security, etc., have been put in place. 

IPC based applications require post installation support to ensure the system is used effectively and the validated status of the system is maintained. The system must be governed by the Quality Management System in operation at the system s location, i.e., change control, IT management procedures, and security procedures governing the granting and removal of system access. 

Maintaining the validated status of the ERP system requires management of the network, servers, ERP functions and data. To ensure the validated status of the ERP system is retained during operation, change control must be in place, along with periodic reviews of system status. Implementing a series of procedures and maintaining physical access control to ERP servers supports the maintenance of validation over the life of the system. 

This approach to the management of infrequent repeat change is only valid, however, if the change, when it was previously made, was properly controlled and documented. If the records are inadequate or incomplete then the MOC process will have to be implemented a second time. People may have memories as to what was done, but this is not sufficient the information must be written down. Moreover, if the change has not been implemented for some time, there is a good chance that not all of the current personnel will have been trained to operate the facility in the new mode. Hence, in this situation, it is best to treat the change as if it is entirely new, and to train people again. 

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