Traditionally, GxP organizations have used different applications to implement GxP and non-GxP functions. For example, many organizations have separate training applications for GxP and non-GxP curricula. The same is true for asset management systems. With the vast advancements in enterprise cloud applications, this tradition is rightfully being questioned. Wouldn’t it be more convenient (and less expensive) to store your non-GxP content in the same place as your GxP content? Could a single system, such as Veeva Vault, be effectively used to manage both?
Veeva Vault offers the potential to manage both GxP and non-GxP content in one place. There are several advantages to housing both GxP and non-GxP content in Veeva Vault, such as:
- Streamlined and simplified user experience due to single platform
- Cost savings in support and administration, licensing, upgrades, and integrations
- Seamless integration between HR Systems and Veeva Vault training application
With the ascent of cloud systems like Veeva Vaults, system admins are finding it easy to configure access and security on a more granular level. It enables them to deliver logically separated content like documents and training items in such a way that GxP and non-GxP content can be completely shielded from each other.
Some potential risks that can arise from storing GxP and non-GxP content in the same Veeva instance include:
- Exposing non-GxP content to auditors when the content is not relevant for compliance purposes
- Unintentionally providing access to confidential documents for users who are not authorized to view or edit them
Thankfully, these risks can be mitigated through Veeva Vault’s robust security settings and state-of-the-art configuration options. Some of the configuration options that can be used to address these potential risks include:
- Custom lifecycles and workflows, associated with specific document types and sub-types
- Document Type group creation for Non-GxP users
- Security profiles, permission sets, dynamic access control (DAC), and user roles
These security settings enable GxP users to have access to the GxP and Non-GxP Veeva environment while restricting Non-GxP users to have access only to the Non-GxP environment. This serves to eliminate any concerns that Non-GxP users will have access to the GxP environment.
Access to the GxP Training can also be strictly controlled through Veeva Vault’s learner roles, curriculum, and training requirements, thus clearly segregating the access to the GxP training materials:
Using robust IT administration policies and procedures, companies can certainly implement a single cloud system for GxP and non-GxP use. Through developing proper SOP’s and creating the appropriate reports and dashboards, it is possible to demonstrate to auditors that Non-GxP users are restricted from accessing the GxP environment and training curriculum.
Please note that Veeva Vault is a proprietary trademark of Veeva Systems. Please visit Veeva’s site for more details: www.veeva.com
You may also be interested in our other blog articles:
- Reduce Time for Study Migration into Veeva Vault – Prana Life Sciences LLC (prana4life.com)
- Reducing Submission Time with Veeva Vault RIM – Prana Life Sciences LLC (prana4life.com)
- Veeva Vault Implementation Groundwork – Prana Life Sciences LLC (prana4life.com)
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