In this two-part blog, ARITHMOS takes an extract from its article series on migrating safety data and cases from legacy pharmacovigilance systems to Oracle Argus. ARITHMOS describes the process involved in data migration and validation principles and considerations during the production phase to ensure efficient and cost-effective pharmacovigilance practices. In Part II of this blog, coming next week, ARITHMOS will discuss what happens after migration and how joining its consortium initiative can result in considerable cost savings.
Oracle AERS premium support will end in 2015, and various other pharmacovigilance systems offer limited support. Therefore, ARITHMOS recommends a data migration project to Oracle Argus Safety, which is an up-to-date pharmacovigilance sytsem that meets all the requirements of computerized systems in the GVP environment.
How would an implementation project work?
As an Oracle Business Processing Services Provider (BPS), ARITHMOS provides the Oracle Argus Safety Version 7 license with payment based on cases entered in a defined time period with no annual maintenance fee. The process for migration includes:
- Business Requirements Analysis
- Configuration Analysis
- GVP Validation Assessment
- Detailed User Requirements definition (including configuration workshop)
- Data Migration strategy
- Configuration set-up and pilot testing system design specifications
- Design, Build and Test Data Migration solution
- System Installation
- Validation Testing (IQ, OQ) and Business QC of migrated data
- End Users training and User documentation
- Validation Testing (PQP) and Production Data Load
- Validation Report
This process can take an estimated 6-8 months to complete, therefore if a legacy system is still in place in your company, it is best to begin the migration process.
Due to increased regulations on safety data and the need to improve data quality, ARITHMOS can guarantee real-time reporting solutions for Oracle Argus Safety Version 7 including integration with Oracle Business Intelligence with reports directly on smartphones and tablets.
Validation Principles and Best Practices
The data migration progress guarantees:
- Risk Based Approach
- Proactive validation
- Use of international standards (GAMP 5) and Internal QMS
- Use of templates and validation scripts
- Monitoring and control over the project
- Multidisciplinary project team covering the key aspects of validation (business analysts, IT experts, CSV & QA specialist)
A dedicated Account Manager will provide support during the production phase including operational technical support, user access management, periodic review and support in preparation and conduction of regulatory inspections. ARITHMOS can also support in the decommissioning of the legacy pharmacovigilance system.
In Part II, ARITHMOS will explore what happens after data migration and how companies can properly maintain their pharmacovigilance system. If your company is considering a migration project from a legacy system to Oracle Argus Safety Version 7, schedule an assessment meeting with ARITHMOS to learn your business and user requirements.