Computer System Validation

Dear sir,
We have already installed chromeleon software with IQ.OQ.PQ completion,.
Now we are going to update the software for the e-logbook facility,
After installing the e-logbook, CSV should be done or not???

Computerized systems should be periodically reviewed to determine whether the system
remains in a validated state or whether there is a need for revalidation. The scope and extent of
the revalidation should be determined using a risk-based approach. The review should at least
cover:

  • maintenance and calibration;
  • review of changes;
  • review of deviations;
  • review of incidents/events (including review of audit trail);
  • systems documentation;
  • procedures;
  • Training; and
  • effectiveness of corrective and preventive action (CAPA);

Reference:-
WHO GUIDELINES ON VALIDATION – APPENDIX 5, VALIDATION OF COMPUTERIZED SYSTEMS, August 2018 (Draft)

Change Management applies to computerized systems subject to validation throughout the system lifecycle from the Installation qualification phase to the retirement. Change Management requires procedures that control and report the implementation of changes that may affect the configuration items (documentation. hardware, software) and/or the validation status of a system. This includes the tracking of changes (triggered by incidents or change requests) from their opening to their resolution.
The Change implementation process triggers the Configuration Management, which covers the identification, recording, and reporting of IT components, including their versions, constituent components and relationships. The changes shall be performed according to the predetermined Change Management Procedure.