Data integrity is the foundation of the pharmaceutical quality control system. Both paper and electronic data must comply with data integrity requirements throughout their lifecycle to ensure the safety, efficacy, and quality of medicinal products. Regulatory authorities both in China and internationally regard data integrity, especially electronic data integrity, as a key focus of on-site inspections of pharmaceutical enterprises.

With the continuous improvement of domestic pharmaceutical regulations, such as the Requirements for Drug Records and Data Management (for Trial Implementation) issued and implemented by the National Medical Products Administration (NMPA) in 2020, pharmaceutical manufacturers in China must adopt production and testing instruments equipped with data audit trail functions to ensure data integrity during drug production.

NMPA Definition of Data Audit Trail
A data audit trail is a series of records of events related to computer operating systems, applications, and user operations. It helps trace from raw data to related records, reports, or events, and from records, reports, or events back to the raw data.

ArchiSign Data Audit Trail Management System

ArchiSign Data Audit Trail Management System, a software product under Rocgene, is designed to meet the needs of pharmaceutical enterprises, CROs, cell therapy companies, and other industry clients. It effectively improves the execution and inspection efficiency for pharmaceutical companies and NMPA regulators, and reduces the application cost of data audit trails for industry users.

Based on continuous user feedback and optimization, the ArchiSign system has been officially upgraded to ArchiSign Data Audit Trail Management System V2.0 Bilingual Version (Chinese & English).

The upgraded ArchiSign Data Audit Trail Management System includes four modules: Role Management, User Management, Signature Management, and Audit Management. It features a new user-friendly interface that is clearer and easier to operate.

System Functions

1. Role Management
- A unique Super Administrator account is provided during system installation with the highest security permissions, which cannot be modified or disabled.
- The system includes default built-in roles for multiple administrators and regular users with different permissions. Only administrator roles can log in to the server backend to modify system settings.

2. User Management
- Only administrator accounts can create users and assign role attributes. Users with different roles have different operation permissions.
- User accounts serve as the unique identity for operators during the data lifecycle.

3. Signature Management
- Configure electronic signature definitions and workflows so that specific operations can only be performed after signing.
- Support multiple signatures and require a sufficient number of specified role users to sign, ensuring data is protected from forgery and tampering.

4. Audit Management
- Review specific user operations and assign audit modes. Generate audit reports for software or instrument operations, including operator, timestamp, process, reason, and all data events: creation, modification, deletion, reprocessing, renaming, etc.
- Generate audit records for reviewed user operations and changes to ArchiSign system configuration.

Product Advantages

Data Security
Ensures batch release data is valid and properly managed, preventing forgery and tampering.

Data Integrity
Complete records throughout the data lifecycle satisfy routine and periodic inspection requirements and improve audit efficiency.

Risk Controllability
Comprehensive audit traceability improves risk detection and supports summary analysis of failure modes.

Experimental Standardization
Hierarchical permissions and role-based responsibilities standardize workflows and improve execution efficiency.

Account Security
Sub-accounts are fully controlled by administrators. Accounts can be revoked when employees leave, while all data remains intact and archived.