Posted on August 27, 2015
Just as medicines and medical devices are held to stringent quality controls, so too is the software used to support the safety and efficacy of those same medicines and medical devices. Choosing a pharmacovigilance (PV) database for your business can be daunting and costly, however Commercial Eyes can help you make a choice that suits your needs and your budget.
Our Drug Safety team have experience using and testing a range of different PV systems, from standalone to fully hosted systems (typically on an Oracle platform). We support clients (many of whom also market their products in the EU and USA) with the selection, validation implementation and management of a pharmacovigilance database solution to meet their specific needs.
In fact, in a recent regulatory agency audit at Commercial Eyes, the database and associated validation package we offered were heavily scrutinised by the FDA without comment. Importantly, careful consideration to meeting 21 CFR Part 11 requirements was at the forefront of the initial decision making process with regard to a suitable system.
We assist our clients’ in their consideration of:
IT infrastructure and resources
Where these are limited, a client might opt for a hosted solution where the database vendor is responsible for IT operations (server hardware, software and backups) and Commercial Eyes for its operation.
From an operationalisation perspective, it’s important that the system a client selects is intuitive, making day to day case processing and reporting writing as efficient as possible.
It’s crucial that software be tested to ensure it meets the User Requirement Specification (URS) and fulfils its intended purpose. Our team has written and completed validation protocols including user acceptance testing. Should a third party database vendor be selected, we can work with them to undertake formal IQ/OQ testing and Regression Plans.
Whether to migrate legacy data or not is a decision to be weighed carefully. Our experience suggests migration is possible with good support in terms of tailored import scripts, execution and validation. Certainly, having a complete validation package in line with FDA (21 CFR Part 11) and TGA regulatory requirements is imperative.
Core pharmacovigilance features
There are a number of core pharmacovigilance features we ask clients to consider including (but by no means limited to):
- Electronic reporting to any regulatory authority
- Processing of ADEs for marketed products and clinical trials in same database
- CIOMS and MedWatch reports
- PSUR line listings reports
- Disaster recovery and data backup planning
This article was written by Dr Jim Malliaros, our Drug Safety Manager.