ANMAT Has Had Provisional Authorities for Nine Years
It is the agency that controls the quality of food and medicines, and has been involved since 2000. According to the AGN the successive head of the agencies "do not consider appropriate" long-term plans for its "temporary nature" within the structure. The IT area needs organization and is "subject to risks that exceed acceptable values."
The authorities of the National Administration of Medicines, Food and Medical Technology (ANMAT, for its acronym in Spanish), who assumed in February 2008, "do not consider it appropriate" to formulate long-term management plans for the "temporary nature" that they exercise within the structure of a An agency that has intervened since 2000. This is one of the observations made by the General Audit Office (AGN, for its acronym in Spanish) in a report on the IT area of the entity that, precisely because of the impossibility of generating long-term actions, is "subject to risks that exceed acceptable values."
As for the physical space where the computer area works, the Watchdog noted that the ANMAT "was not aware of the need to protect facilities or invest in computer resources," and pointed out that "there is no monitoring of factors Environmental protection, such as protection against fire, dust, high voltage, excessive heat and humidity."
In addition, the report added that "loose plugs and missing cables, panels are absent in the processing center ceiling," which also has no fire protection, and the fireproof box containing the original software is in a tank next to furniture and other elements that are combustible.
On the other hand, the control and correction of the data that are loaded in the computer system of the ANMAT "is a manual work done individually, and the rules are not transmitted from one employee to another when there is turnover of personnel," stated the AGN. However, "management assumes that the data is accurate, because in the process a computer intervenes."
If, for any reason, something happened to the computer data of the agency, "there is no formal backup procedure, it is not defined what information should be protected or how the backup copies should be preserved," said the Audit report, and added: "The personnel responsible for making the backups were not trained for that task."
IT employees do not have "formally defined" roles. The AGN detected that the staff "assume responsibilities without the position within the organization chart and without being duly compensated." In addition, there is no adequate process in the ANMAT to evaluate the performance of workers, nor was there any evidence of any training plan, but it is the employees themselves who take courses "on their own initiative."
ANMAT is under the orbit of the Ministry of Health and its objective is to ensure that medicines, food and medical devices have safety, quality and efficiency - understood as compliance with therapeutic and nutritional aspects. The situation of the agency, which has provisional authorities nine years ago, not only impacts on the computer area. The AGN concluded its report, approved in October 2008, stating that "there is no ANMAT budget formulation procedure" which guarantees the establishment of an annual expenditure plan.