MAN-13 Data Export

Manual for project data export, particularly related to 21 CFR Part 11 data retention policy compliance

1. Introduction

1.1. Purpose

The purpose of this manual is to guide users through the process of exporting all project data from Ketryx, ensuring data continuity by providing the ability to back up project information.

1.2. Scope

The scope of this manual is the data export mechanism from Ketryx.

2. Exporting all data from Ketryx

21 CFR Part 11 outlines requirements for electronic records and signatures, mandating that electronic records and signatures be trustworthy, reliable, and equivalent to paper records and handwritten signatures, with specific data retention requirements mirroring those for paper records. Ketryx ensures continuity for users by providing the ability to export all data — backing up complete project information. Ketryx offers two options for exporting your data.

2.1. Project export mechanism

Ketryx provides the capability to generate an archive containing all relevant project data in JSON format. This mechanism is ideal for creating a complete backup or fulfilling internal data retention policies related to compliance guidance, such as 21 CFR Part 11.

To enable this functionality, please contact our support.

2.2. API access

Ketryx provides programmatic access to manage configuration items and records, including data export. Please refer to the Ketryx Item API documentation for further guidance.