Many software developers have chosen not to adjust to the electronic data exchange modalities provided for in the new international regulations. In other cases, they did it by offering customers expensive or complicated solutions.
Safety database implementation timelines
The consequence is that now many pharmaceutical and service companies are evaluating criticalities and advantages of changing the old pharmacovigilance software with a native ICH R3 one. Every change raises legitimate doubts and necessary insights. We understand the state of mind of those who find themselves having to rethink consolidated methods.
The need to acquire procedures that sometimes are very different from the previous ones is undeniable. The leap is even more evident when pharmaceutical companies manage data storage with spreadsheets.
Potential customers always ask us what timeframe is needed to adapt to the new operating mode.
So, we explain: on average it takes 6-7 weeks to migrate to the new platform, to address the software validation and data migration and to train staff to the use of SafetyDrugs, the software for the pharmacovigilance management developed by Max Application.
Validation is often the variable on which the overall timing depends, with time dilation sometimes up to 4 months.
Should the client needs request it, and with the full active cooperation between the parties, a full operation can be achieved even in just 3 weeks.
Safety database implementation phases
There are five stages of the transition to new software.
1) Initial analysis. It is the moment when every aspect is weighed: the integration path is described and all the information necessary to prepare for the new process are provided to the clients.
2) Fine-tuning of the data coversion plan. We analyse the original database structure, software or Excel sheet, and we map the fields according to the data conversion to the new database.
3) Validation. The Computer System Validation (CSV) is the process that documents the compliance of the safety database with the requirements defined by the EMA and FDA guidelines. It is a phase that sees us at the side of the client in providing the competence for the tests execution.
4) Training. Generally, four days are needed to train users, to provide the corresponding certifications to operators and administrators. At least two days are suggested at the client’s office and the remaining ones via webinars.
5) Go live. The launch of the new system projects the company into the ICH R3 dimension. New customers benefit from a dedicated online assistance channel, through a portal specifically developed for ticket management. The assistance procedures follow ISO:9001 certified quality standards.