Ensuring Accurate and Regulatory Compliant Safety Data Migration to Oracle Argus Safety

The migration of safety data between systems is a complex change management process and requires a strategic approach and specialized expertise to preserve data quality and integrity. With a stringent pharmacovigilance regulatory landscape, pharmaceutical companies ensure that they adhere to the principles of Good Pharmacovigilance Practice (GVP) during the entire data migration process to account for safety data integrity between the source and target systems. According to GVP Module I, computer systems involved in essential pharmacovigilance activities must undergo rigorous checks, qualification, and validation. Therefore, companies must adopt a risk-based data migration strategy based on the source safety data volume, data format, ongoing safety operations, compliance objectives, etc. to ensure a smooth and successful transition. 

Our Capabilities in Safety Data Migration

Oracle Partner - Techsol lifesciences

Our Safety Database Migration & Related Validation Services

At Techsol, we understand the critical nature of safety data. Our expert team uses proven data migration methods with advanced tools to ensure your data is transferred with the highest level of accuracy. We meticulously validate each data point to avoid discrepancies and preserve data integrity throughout the migration process. Our data migration qualification is performed using the GAMP5 Risk-based methodology. We provide consulting guidance to your team at every step right from defining the data migration strategy to post-launch and hypercare.

Safety Data Migration Strategy & Planning

We help clients to establish a risk-based safety data migration strategy and prepare the migration plan based on:

>  Source data format and case volume in legacy safety systems 

>  Data migration scope, business requirements, timelines & deliverables 

>  Quality and regulatory compliance objectives 

>  Readiness of the target Oracle Argus Safety Cloud platform

>  Identified measures for data quality assessments

 

Process Review

Safety Data Migration Execution

 Source Data Collection: Our team uses advanced ETL tools to perform safety data extraction from different source systems and raw files (PDF, XML, JSON, etc.). The collected data is then profiled with data quality checks to ensure that all data points are available for migration. 

Data Preparation & Transformation : All E2B field mappings, data cleansing, data transformations are performed for accurate migration into Oracle Argus Safety.

Post-Migration Review and Support: After migration, we conduct a thorough review to ensure data accuracy and compliance. We provide ongoing support to address any issues and optimize system performance.

Clinical Trial Site Selection

Safety Data Migration Testing & Validation

We use the GAMP-5 Risk-based validation approach to perform Data Migration Qualification. 

Key Deliverables

  • Safety Data Management –  Requirements Gathering Completion
  • Authoring Systems Requriements Specification 
  • Safety Data Migration Plan
  • Setup of Case Management Management workflows
  • Validaton Master Plan Development 
  • Risk Management Report
  • IQ / OQ Test Scripts Preparation & Execution 
  • Data Migration Qualification (DMQ)
  • Incidents & Deviation Management 
  • Requirements Traceability matrix
  • 21 CFR Part 11 Compliance Assessment Report 
  • EU Annex 11 Compliance Assessment Report 
  • Validation Closure Report
  • End user and administration training
  • Project Management

Common FAQs

The common pitfalls and challenges faced during safety data migration include:

  • Inadequate planning and an insufficient data migration plan
  • Limited knowledge of the safety database and its functionality
  • Misinterpreted business rules within the safety database
  • Technical issues related to types and limits of input characterization
  • Inconsistent available data
  • Follow-up or duplicates management
  • Data cleaning process
  • Case related documentation (source data, correspondence, etc.)
  • Poorly defined scope and inadequate testing, leading to a typical success rate of only 16-60% for the data migration portion of projects
  • Mapping errors, different dictionary maintenance practices, and MedDRA/WHO coding inconsistencies

To mitigate these challenges, it is crucial to develop a thorough Data Migration Plan that evaluates different approaches, products, or the number of cases that will be migrated. The plan should include a clear strategy, guidance to mitigate interruptions, and steps to achieve compliance. Additionally, pre-migration testing, configuration of migration software, and parallel process reengineering can help address these pitfalls

Yes, Techsol can set up and automate the generation of various regulatory reports, including ICH E2B R3 electronic submissions, periodic safety update reports, and other compliance-related documentation, ensuring ongoing adherence to regulatory requirements.

Techsol provides various training sessions tailored to different user roles, including case management, application administration, and superuser training. This ensures that all users are well-equipped to utilize the Argus Safety system effectively.
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