Preparing data for computerization includes completing a data entry form, deciding on a drug classification system, and preparing codes and catalogues for standardized data entry.
If data are usable, they can be entered in the system by: converting old data; stopping new applications and entering the backlog; or entering the backlog gradually while accepting new applications.
If data are unusable, an inventory of the market situation must be made, requiring that companies with products on the market that wish to keep marketing them make this known in writing to the DRA. The other option is that companies submit a full application for marketing authorization based on published documentation and standards.
When computerizing, automation of drug registration work takes place at various steps.
Whatever software system is selected for use at a DRA, staff will need to be trained in how to operate it.
For a computer-assisted drug registration system to function effectively, adequate computer support and maintenance must be available, and the type of support needed differs for a network versus a stand-alone system.
The DRA budget should contain adequate funds for computer system supplies, upgrades, and maintenance.