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Data Migration

Moving regulated content and data in a GxP environment presents a unique set of challenges.  Making sure the migration has the proper controls in place and ensuring that the testing strategy and execution are compliant, is critical to migrating your legacy data to a 21CFR Part 11 compliant application..

With over 30 Million records migrated, VISTX has the knowledge, experience and methodology to deliver consistent and compliant results that our clients have come to expect

PHASE I – Strategy and Planning

Developing a clear strategy and plan is key to a  successful migration.  For example:

  • Will you migrate all data?
  • What about Audit Trails?
  • Does data need to be enriched?
  • Do you need to correct any data before/during the migration?

These are just a few of the key considerations that need to be addressed as part of the Planning process.

Complete Data Analysis and Scope
  • What data will be migrated (deleted, etc.)?
  • Will you migrate audit trails?
  • Will you need to transform data?
  • Will you need ro cleanse data?
  • Will you need to enrich data?
  • What tools will you use to move the data?
Develop Data Migration Strategy

Developing your strategy is a critical component to migrating your regulated content and data.  For example:

  • What will the rollout look like?
  • Will you need downtime?
  • Delta migration?

VISTX has experience working in a number of different environments and applications and can assist in asking the right questi9ns and driving toward the answers.

Determine Governance Strategy

How will you maintain control over your data and content?  This will be a critical question in any audit or inspecti9n.  Working closely with the Business and Quality teams, VISTX can provide the necessary migrati9n and compliance expertise to ensure that you have the proper answers during these inspecti9ns.

How will you test and verify the migrated data.  Samopling?  100% verification?

What are the training requirements for the Migration and Business teams?

Create Data Migration Plan

The data migration plan should describe the entire migration process, including as a minimum:

  • Migration project Introduction and scope
  • System Description(s)
  • Roles and Responsibilities
  • Required Deliverables
  • Risk Management Strategy
  • Data Migration strategy, including the source, staging, and target environments
  • Software tool overview and strategy for ensuring compliance and fitness for intended use
  • Data Migration Lifecycle
  • Migration Steps and Technical Activities
  • Data Mapping and Modeling Activities
  • Transformation Rules
  • Data Verification Strategy and Acceptance Standards
  • Cutover plan
  • Rollback strategy
  • The data migration plan should be approved by the process owner, system owner, quality unit, and SMEs as appropriate.

 

PHASE II – Execution and Deployment

Our team of Cloud and Compliance experts can help you execute as outlined in the Migration and Compliance Strategy.

Create Detailed Plan

The following are the major actives for creating the detailed plan:

  • Create the rollout plan
  • Create the Commonicatioin Plan
  • Create the detailed Project Schedule
  • Create the Resource Plan
  • Create the Training Plan
Migration Validation

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Qualify/Validate Migration Tools

In order for you to use ANY tools (including SQL Queries), you will need to first qualify and/or validate the tools to be utilized to move your GxP data and content.

This is a critical step to ensure you move the data correctly and stay in compliance.

Production Cutover

Ready to move the data and content into Production.  Make sure you are communicating any downtime that is required.  a Delta migration (migrating any changes since the last extract, may be necessary when dealing with large migrations.

Migration Dry Runs and Testing

Repeated Dry Runs allows you to Test and make any necessary adjustments to make sure the data is being moved correctly.  In addition, the Dry Runs make for a much smoother Validation, minimizing the number of discrepancies and deviations.  A little extra effort upfront can save a lot of time later in the process.

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