As the life sciences continue to migrate to the cloud, data integrity is paramount to any successful project.
Transferring data from one database to another is a skill in itself and the correct people must be involved to ensure a smooth transition of data.
So what are the main questions you should ask regarding data integrity in the cloud?
Below are a number of questions that should be asked and verified before any migration to the cloud.
If data has to be migrated how can we ensure that it is correct?
What are the validation checkpoints that should be adhered to?
How do you know the data has not been changed?
Can we use bit checking when transferring data between servers?
When a data restore is performed (business continuity or disaster recovery) how are you assured of data integrity?
When we transfer very large volumes of data across an interface (e.g. material master from SAP to MES) what is an appropriate sample size for data verification? And which sampling method to use?
What data migration tools can be used and do they need to be validated too?
Can I use 100% manual inspection?
How long should the old data from the legacy system be stored?
Does 21 CFR Part 11 apply to the migration process?
- Digital Vs Electronic Signature
- Authentication and Non-repudiation of Data
- Is the audit trail an electronic record?
- Data Integrity
21 CFR Part 11
If you would like to learn more about data integrity and 21 CFR Part 11 click here to purchase our Easy to Understand Guide to 21 CFR Part 11