When it comes to safety systems, pharmacovigilance professionals must take into consideration the guidelines and legislation laid out my regulatory agencies. Computer systems used to manage safety data are subject to rigorous validation testing to determine if they are suitable to manage safety data in the clinical environment.
Last month, ARITHMOS hosted the second edition of Pharmacovigilance Day in Milan, a seminar which invites pharmacovigilance professionals to meet and discuss the industry’s most pressing issues. This year, a senior PhV Inspector from the Italian Pharmaceutical Association (AIFA) presented his considerations on computerized systems and Inspection-Readiness especially in terms of data migration and the PSMF.
According to the Good Vigilance Practices (GVP) applied in Europe, “facilities and equipment which are critical for the conduct of pharmacovigilance should be subject to appropriate checks, qualification and/or validation activities to prove their suitability for the intended purpose. There should be processes in place to keep awareness of the valid terminologies in their valid versions to keep the IT systems up-to-date accordingly”.
This is of utmost importance in the pharmacovigilance field, especially when it pertains to the transfer of safety data from outdated or legacy systems.
What does this mean for the migration of pharmacovigilance data?
More specifically, GVP Module VI addresses the need for a quality management system to ensure compliance with standards and documentation including data collection, transfer and management.
Therefore, there is a need to establish which processes will be used in every step of data migration and who will be involved in the data transfer and their role. Next, the checks that will be carried out after migration next to be defined to guarantee data integrity and completeness in the database. Lastly, a documentation and archiving process needs to be defined.
A quality management process needs to be in place to keep track of the activities done before, during and after the data transfer to ensure that the transfer to the new database is secure and complete and that the processes used did not result in the loss of safety data.
Verifying data migration is essential when:
- There a new safety database is implemented
- The acquisition of a new company or the merging of two companies
As our expert points out, data migration is necessary because:
- Cumulative data in ICSRs are requested for the analysis of signals and for a risk/benefit analysis
- PSURs, where foreseen, must contain cumulative “summary tabulations” of adverse reactions
- Regulatory agencies can request cumulative reviews for types of specific events
- Occasionally follow up information can be requested for previous signaled cases
Additional Considerations for the PSMF
Besides safety databases, the PSMF must report any electronic system that collects, registers and reports safety information including medical information systems, data banks or any other system in clinical trials that collects safety data.
Common deviations for computerized systems include the absence of a disaster recovery and business continuity plan, no reconciliation between the pharmacovigilance database and other department databases and the failure to enter all AEs into the PhV database.
ARITHMOS recommends a full business and technical analysis of pharmacovigilance needs before proceeding with data migration projects. Our multidisciplinary team of business analysts, life science application specialists, pharmacovigilance system and process experts and computer system validation experts can prepare a proper user requirement analysis and a risk management plan to guide companies through data migration projects to guarantee compliance with regulatory standards.