GxP Compliance for Life Sciences
Secure File Transfer Compliance with FDA 21 CFR Part 11
Ensure Regulatory Compliance and Maintain Data Privacy Controls
GxP refers to general “good practices” regarding quality guidelines and regulations, with the “x” standing for various fields or industries. Key functionality for creating, storing and managing GxP-regulated files includes
- End-to-end encryption (E2EE) of data in transfer and at rest.
- Granular audit trails for data transfer and configuration changes.
- Strong controls for user and system authentication.
- Simplified file transfer between external R&D teams.
Identification
Users of the system have unique credentials to access data. Administrators may configure Thru access via SSO using a SAML 2.0 identify provider (IdP). Additional layers of access may be added with multi-factor authentication (MFA).
Systems such as SFTP clients authenticate automatically, requiring a unique user authenticating with a password or SSH key.
Role-Based User Access (RBAC)
Assign role-based access to each data repository or flow that assigns permissions to end-users based on their role within your ecosystem. RBAC provides granular control in simplified method adhering to the principle of least privilege (PoLP)—all of which contribute to a more robust and secure file transfer process.
Encryption
Ensure files are encrypted in transit and at rest. Add an additional layer of protection by encrypting not only the transport channel and the storage vault but also the actual file itself using PGP encryption.
GxP Audit-Readiness for Each Document
Time-Stamped Audit
Thru records real-time and historical data for all activity associated with a file transfer or a file stored as well as user configuration audit of the system.
File Versioning
The timeline for data stored in Thru File Sharing system records who created a version, what time it was made, the size of the file and the file’s owner.
World’s Leading Life Sciences Companies Trust Thru
Secure File Transfer Overview
There is more to security than compliance. Learn about other measures Thru takes to ensure security.
