Computers have changed the ways in which people work in virtually every sector of industry and services. It is important to understand that the computer is a tool to assist in nearly every stage of the drug registration process. Properly used, it is not simply for recording information and decisions at the end of the process. Some benefits of computerizing that regulatory authorities will realize are detailed below.
More time for professional work
Initially, the introduction of computer-assisted drug registration will put an additional burden on staff, especially when existing information needs to be examined and organized. However, once the system is operational, staff will face less routine and clerical work, and will have more time available for technical and professional work because many frequent tasks, such as searching for information on similar items and producing certificates, will be simplified or automated.
After adopting SIAMED, staff in an African country had time to read technical literature to update their professional knowledge. This was made possible by being able to use the system to ascertain in a few seconds, for example, whether marketing authorizations had been given before for a given active substance or excipient. They could also easily see what decisions had been taken before on similar drugs. Most importantly, correspondence and certificates are generated automatically by the system, so staff did not need spend time correcting typing mistakes.
Fewer imprecisions, oversights, and mistakes
In a manual system it is very common that substance names or quantities are stated incorrectly, or in a different way in different documents related to the same drug item. This causes confusion and gives the impression that regulatory work is done unprofessionally. A computerized system will greatly reduce these types of errors, because it is designed to help ensure consistency in data entry.
Improved communication within the regulatory authority
Operational links between drug registration, quality control (QC) laboratory, and drug inspectorate officials need to be effective and timely. In a manual system, when information needs to be exchanged, officials may contact each other on the phone or by visiting the appropriate office. This may require several days when officials are out on field visits or work on different shifts. A computerized system permits recording information on inspection results and ensures its linkage to drug registration data, and the computer data is easily accessible at any time to users with the appropriate level of access.
Most correspondence and certificates issued by regulatory authorities can easily be standardized. The adoption of a computerized system allows the authority to issue such documentation almost automatically in a predefined format. In addition, computerization greatly facilitates preparation of reports.
Improved quality of work
In a manual system, data recorded to identify a drug product and its status are generally stored in the application file itself and only selected data are transferred to a manual card system to permit retrieval. This, in the best situation, may include: marketing authorization number, company name, drug item name, and name of “main” active ingredient. Usually, no other criteria can be used to retrieve information. In this situation, the preparation of reports is a time consuming exercise that requires intensive editing to overcome inevitable copying and typing mistakes.
In a computerized system it is very easy to retrieve and review decisions previously made on a similar drug item. This ensures that technical decisions are made with a proper degree of consistency and transparency. The ease of retrieval and access to a great variety of up to date reports reduces the likelihood of inappropriate duplications, and permits a global view of the drugs already authorized. A computerized system can also track any application process, allowing the regulatory authority to determine the status of an application at any given time, and raise alarms when the process is delayed beyond user-defined limits.