Data Migration in GxP Environments
Data Migration for
FDA Regulated Companies
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GxP environments provide unique challenges for control of electronic data, particularly during data migration projects. Ofni Systems can create an appropriate testing strategy for your data migration project and migrate your existing legacy database into a Part 11 compliant application. Ofni Systems can create:
- Data Migration Plans
- Migration Scripts
- Testing and Verification Services
- Acceptance Testing
Ofni Systems can perform all phases of the data migration process:
- Analyzing Legacy Data and Databases
- Data Extraction/Data Conversion
- Data Repair and Verification
- Data Integration
- Use of Data in the New Environment
Ofni Systems will produce all data migration plans and reports required to document data migration and to be compliant with 21 CFR 11.
Experts in GxP Data Migration
- Experience with FDA-regulated companies. Ofni Systems provides services to companies subject to FDA regulations and is experienced with electronic record compliance. Ofni Systems can seamlessly transfer data from your legacy systems to your new systems without concerns about data corruption or loss. We can also suggest best practices for data migration projects.
- Higher quality documentation produced efficiently and quickly. Ofni Systems uses FastVal to produce test plans and testing protocols designed to demonstrate that your migration plan meets all of your business requirements and regulatory requirements.
- Migration Tools designed for GxP environments. Ofni system has proprietary tools designed to migrate databases in regulated environments.
- Your documents, your standards. Ofni Systems professionals can use your existing documentation standards, producing documents identical to your existing documentation. Our professions can either follow your data migration program or our own internal best practices and methodology.