Ensuring Accurate and Regulatory Compliant Safety Data Migration to Oracle Argus Safety
Our Capabilities in Safety Data Migration
- With 15+ years experience in Drug Safety and PV technnology consulting, we have completed 35+ safety data migration projects
- Dedicated team of 75+ seasoned Argus Safety Technical and Functional Consultants
- Our ready-to-use Argus Safety Data Migration and Validation accelerators saves 50 to 70% time and effort
- Experienced with on-prem, cloud to cloud and other forms of legacy data migrations to Oracle Argus Safety
- Recognized by Oracle Health Sciences as a preferred Tech Services Provider
- Clients trust us an extended Safety Technology Partner for end-to-end services
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.
We utilize our Data Migration tool CompierMigrate and excute end to end data migration in an accelerated and with 100% data verification. CompierMigrate has pre-certified, ready to deploy data mapping and migration logic for various targets and source systems including Argus Safety ArisG/ LSMV, pvworks, Veeva etc.
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
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.
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.
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