WT-ATS R1 GMP Audit Trail System
Model: WT-ATS R1A standalone GMP audit trail platform for pharmaceutical plants—SHA-256 hash chain tamper-proofing, one-click aggregation of LIMS/ERP/OA audit trails, compliant with GMP Annex 11 / EU Annex 11-2025 / FDA 21 CFR Part 11, with private deployment keeping data within the server room.
Specifications
| Product positioning | Standalone GMP audit trail platform (not embedded in a business system) |
|---|---|
| Development language | PHP 8 + MySQL 8 (BaoTa one-click deployment) |
| Deployment method | Private deployment, data stays on the customer's server |
| Data tamper-proofing | SHA-256 hash chain linkage + one-click integrity verification |
| Regulatory compliance | GMP Annex 11 / EU Annex 11-2025 / FDA 21 CFR Part 11 / ALCOA++ |
| System integration | HTTP API access, AppKey+AppSecret signature authentication to prevent forgery |
| System self-audit | The audit software audits itself (independent Admin Logs view) |
| Alert management | 10 configurable rule categories, with grading / handling lifecycle / trend analysis |
| QA review | Tasks / batch review / review by exception / electronic signature / review reports |
| Log storage | Yearly table partitioning, retention ≥10 years, archiving supports WORM push |
| Log export | CSV/PDF export, with watermark and hash verification summary |
| Operating mode | Normal mode / GMP pharmaceutical-plant compliance mode (global switch) |
| User permissions | Four-role RBAC: administrator / QA reviewer / viewer / read-only visitor |
| Password policy | Mandatory complexity / 90-day expiration / lockout after consecutive failures |
Features
- Hash chain tamper-proofing, with integrity verification that can be demonstrated on the spot
- Standalone platform with one-click API access to LIMS/ERP/CRM/OA audit trails
- Full coverage of China's GMP Annex 11 + international EU Annex 11-2025 + FDA 21 CFR Part 11
- System self-audit (the audit software audits itself), covering items mandatory for drug regulatory inspections
- Private deployment, keeping data within the customer's server room
- Delivers a full set of CSV validation documents (URS/SDS/risk assessment/IQ/OQ/manual)
- Yearly table partitioning design for worry-free query performance with large data volumes over 5-8 years
- Alert grading + QA review closed loop, aligned with the new requirements of EU Annex 11-2025
- Operation timestamps are uniformly generated by the server and cannot be forged by third parties
- There is no edit or delete log button whatsoever—even administrators cannot delete audit records
Applications
- GMP data integrity inspection and remediation at pharmaceutical companies
- Audit trail management for APIs / formulations / biologics / CDMO plants
- Unified aggregation of audit trails across multiple systems such as LIMS/ERP/CRM/OA
- Compliance for pharmaceutical companies exporting to Europe and the US (EU Annex 11 / FDA Part 11)
- CSV validation of computerized systems for newly built plants
- Implementation of the "Requirements for Drug Records and Data Management" in traditional Chinese medicine / chemical drug companies