Pharmacovigilance sector services
Good Pharmacovigilance Practices (GVP)
The Good Pharmacovigilance Practices (GVP) is established, with the objective of facilitating the development of obligations for the pharmaceutical industry, as a set of quality standards regarding the organization and operation of the drug marketing authorization holders. They are intended to provide a rapid and comprehensive response to any request for information from the competent authorities on drug safety.
The use of computerized systems can facilitate rapid access to information and can also be a way of reporting data by health agents and patients. Likewise, the systems can be used as tools in the management of industrial processes.
A computerized system is a set of physical elements (hardware) and associated programs (software) designed and assembled to perform one or several established activities.
We analyze the risks associated with computerized systems that support the activity of pharmacovigilance, the requirements demanded at the regulatory level in this regard, as well as the definition of the validation project throughout the life cycle of the system.
GVP requirements for computerized systems
Good pharmacovigilance practices apply mainly to the records of cases managed in the organization. Within its scope are the registration and management of electronic data, functionalities of computerized systems in the management of processes and their associated security, the assurance of patient confidentiality, documentation associated with the computerized system and its validation, technology service providers, training and security associated with end-users who will make use of the system, and integrations between computerized systems both for the collection and recording of data and for the transfer of information to the competent authorities.
The requirements of good pharmacovigilance practices are directed to the administrators of the computerized systems, the characteristics of the computerized systems themselves, and/or to the verifications of the final behavior of the process. Therefore, their application will have both a technical and procedural part of the system.
Validation of computerized systems
Computerized system validation is a documented demonstration that a computerized system is suitable for its intended use. A computerized system is a set of physical elements (hardware) and associated programs (software) designed and assembled to perform one or more established activities.
The main risks of the computerized process in the field of pharmacovigilance are to ensure the integrity of the data in the introduction of the case information, to carry out an exhaustive follow-up of these data in the whole life cycle of the electronic registry through the audit trail and to ensure the export and transfer of data of the cases treated to the platforms of the competent authorities.