Validation of the upgrade to ICH R3

Halfway through the transition from R2 to R3, after the initial analysis and the data conversion plan, we find a fundamental step which consists in validating the whole process. It is a delicate phase in which different areas are involved. In fact, it concerns the environments installation, the data conversion and the software functioning. Below the situations in detail.

 

Validation

First of all, it is essential to define the SafetyDrugs 6 installation: Max Application will require to fill an installation questionnaire, in order that all necessary details are provided.
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 specific request, makes its own technical know-how available to provide support during the entire process.

 

In case of 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.