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Quality System Data

In regards to 820.180 (c), all quality system records (both metadata and files) are retained in the GAS database for the lifetime of the system. Closed records can be viewed by authorized users but are not archived or deleted. To maintain referential integrity of records, the application provides no mechanism for modifying or deleting closed process items, item history or audit trail records. The data stored in GAS is retrievable until the installation is deleted from the server in the event that you discontinue as a customer.

The underlying audit trail in the software is permanent, so it's possible to go back (with some effort) and review all changes made to process items.  For example, if you wanted to see who modified a change request or a CAPA Request on a particular date, that information is always available in the audit trail.

Database Backups

We perform various backups of customer databases in the event we would need to restore their database. After 30 days, backup files age out and are removed/deleted. The backup files are not archived.

Please contact support@grandavenue.com for a copy of our backup policy.

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