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Computerized System GxP Requirements | Standard Checklist


It would be impossible to list all the documents GxP could require. Although each industry has its own criteria to administer, there are some core, standard GxP requirements that can benefit all. As long as you answer yes to each question, you are well on your way to implementing industry-specific requirements.

1. Is there a documented process of procedures for - 

  • the storage, review, maintenance, retention and archiving of data and documentation;
  • guranteeing the security and controlled access of all business data and documentation;
  • deviations from standard procedures;
  • corrective and preventive actions (CAPA)?
2. Is there a backup system for documents?
3. Is audit trailled information on document changes stored along with superseded versions?
4. Is there a process of procedures for -
  • continuously validating and qualifying the equipment documenting time, date and relevant personnel;
  • estblishing agreed and standardized tolerance limits for equipment and asset health;
  • replacing equipment or assets whose health falls outside the agreed tolerance limits;
  • implementing a continuity plan in the event of IT disruption;
  • documenting changes, maintenance actions, errors, and repairs?
5. Are instruction and operation manuals available for equipment assets?

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