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Roles and permissions
Access to modules, lists, objects and operations can be limited according to user responsibility.
Security
Quality data protection without unnecessary complexity
Ingenes Studio QMS combines access control, secure sign-in, change history and data immutability mechanisms to support production, audit and regulated environments.
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Secure sign-in
The system can use external identity providers such as Google, Microsoft and Microsoft Entra ID.
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2FA and access policies
Two-factor authentication and identity provider access policies increase user account security.
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Audit trail
Important operations can be recorded with information about who changed what and when.
Immutable change history
For data requiring special protection, we provide an immutable change history standard. Events can be preserved in a WORM model, write once, read many, using immutable Azure Blob Storage.
- change history stored in a form resistant to modification and deletion during retention
- protection against data changes even by highly privileged administrative users
- time-based retention and legal hold mechanisms for records that must be preserved
- ability to reconstruct change history for audits, complaints or inspections
Requirements supported by this model
The immutable change history model supports GMP requirements for data integrity, operation accountability and retrospective record review. It helps meet ALCOA+ principles: attributable, legible, contemporaneous, original, accurate, complete, consistent, enduring and available data. This is especially relevant for quality records, deviations, CAPA actions, audits, reviews and approval decisions.
Additional protection mechanisms
Encryption and transmission
Communication uses secure connections and data is protected at the infrastructure level.
Backups
Backup and recovery strategy can be adapted to organizational requirements and data criticality.
Access separation
Permissions limit data visibility between departments, locations, roles and processes.
Operation monitoring
Logs and system events support unusual activity detection and incident analysis.
Do you want to discuss security requirements for your organization?
We will show how to configure roles, sign-in, audit trail and immutable change history for your scenario.