In the ICH R3 transition is essential validation of the entire process. It is a delicate phase in which different areas are involved. In fact, it relates both to the installation of the environments, to the data conversion and to the functioning of the software.
It is the intermediate condition of the transition to the new ICH, preceded by an initial analysis and by the data conversion plan and followed by training and go-live. For this phase it is first of all essential to define the installation of SafetyDrugs 6: Max Application will request the compilation of an installation questionnaire in order to provide all the necessary details.
The database is created on the cloud, then the Test environment is configured as defined with the client, who will be able to deepen all topics during the training.
Following the signing of the installation report, as acceptance of the activity performed by our technicians, the formal tests are run and the IQ – Installation Testing is released.
In addition, we also offer the Quick Start Validation Kit, a set of documents compliant to the GAMP5® guidelines, containing the Standard Market Requirements, the Quality and Project Plan, the Design Specifications, the Functional Specifications, the Regulatory Compliance, the Traceability Matrix, the Installation Procedure and the Unit and Integration Test performed in our standard environment (OQ – Functional Testing).
Since the Computer System Validation is the most onerous task for the client, Max Application, on a specific request, makes its own technical know-how available to provide support during the entire process.
In case of a request for a data backlog, the legacy cases are imported in the Test environment and the quantitative and qualitative validations of the conversion are provided:
– the quantitative validation verifies the correspondence of the totals of the cases present in the original database and those contained in SafetyDrugs 6. Moreover, a check is also performed on some subtotals, such as the subtotals by SERIOUS/NOT SERIOUS cases, of the cases by PRIMARY SOURCE COUNTRY, of the cases by REPORT TYPE, of events by MedDRA SOC, of events by OUTCOME and of the subtotals by DRUG.
– the qualitative validation compares data between the old and the new database, of every single field migrated on a sample of random cases.
At this point, the Production environment is created as an exact copy of the previously validated Test environment. Now everything is ready for the go-live.