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C-realize Data Migration planning
With the advent of Artificial Intelligence, a controlled data lifecycle integrated with a controlled software development lifecycle is key in ensuring reliability and compliance of computer systems.
Data Migration fundamentals
The main reason why Data Migration is such a crucial step in computer systems validation is that a fully organized and controlled procedure can ensure the accuracy and completeness of the transferred data and its consistency with the original data. Both are essential for regulatory compliance.
Data migration should adhere to the GAMP guidelines laid down by the Good Automated Manufacturing Practice technical subcommittee of the International Society for Pharmaceutical Engineering (ISPE) that forms a ‘bible’ for manufacturers and users of automated systems in the pharmaceutical industry.
Data Migration Plan
The GAMP5 guide describes the principles and procedures to ensure that computerized systems are validated, including a data migration process. This directs the creation of a plan, roles and responsibilities within the migration team, deliverables, and a risk-based approach that takes account of tools to be used and any third parties involved.
The plan should also set out in detail migration activities such as mapping, transformation, and verification. The key here is thorough understanding of both source and target systems.
Data migration challenges
The ultimate aim of a fully compliant data migration process is to be able to confirm that all required data have been migrated accurately, completely and consistently. Verification techniques and tools can be used to corroborate complete data transmission.
Reliability of source data must also be considered an essential part of the data migration process. to avoid mixup with reliable data in the target system.
Confirming migration success
At the end of the process, the final report should summarize the results of the data migration activities including an analysis of all issues that happened.
Data migration typically involves the use of software tools to automate various migration activities. The various risks are described in other C-realize blog posts on the various CSV phases and it’s important to establish that each tool used is intrinsically fit for purpose.
A controlled data migration process is essential for assuring data integrity and regulatory compliance. Without the use of the correct techniques and tools, this process can get very laborious. A risk-based approach should be adopted when including these in any migration plan.
Resources
Click on C-realize Blog to learn more about Computer System Validation and Data Migration.
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