Compliance Built Into
Every Action
Enterprise-grade quality and compliance for pharmaceutical laboratories. 21 CFR Part 11 compliant by design with ALCOA+ principles, comprehensive audit trails, and complete investigation workflows built into every operation.
ALCOA+ Data Integrity Principles
All nine ALCOA+ principles are enforced throughout the system, ensuring complete data integrity and regulatory compliance.
Attributable
Every action is attributed to a specific user with complete user context
Legible
All data is readable, clear, and permanently recorded
Contemporaneous
Data is recorded at the time of the operation with precise timestamps
Original
Source data is preserved with immutable audit trails
Accurate
Data validation and integrity checks ensure accuracy
Complete
No data loss or gaps in the audit trail
Consistent
Standardized data formats and validation rules
Enduring
Permanent audit trail with 7-year retention
Available
Audit information is accessible and retrievable
Centralized Audit Trails
Comprehensive, tamper-evident audit trails for all CRUD operations across the entire application. Every action is logged with complete context, cryptographic integrity, and 7-year retention.
- Complete audit trail for every action
- SHA256 checksums for tamper evidence and integrity verification
- User attribution with session ID, IP address, and user agent tracking
- Before/after value tracking for all data changes
- Microsecond precision timestamps for contemporaneous recording
- Cross-table audit trail queries and comprehensive reporting
- Automated integrity verification and chain validation
- Robust retention policy
21 CFR Part 11 Compliance
Full regulatory compliance with FDA 21 CFR Part 11 requirements. Electronic signatures, secure audit trails, and data integrity built into every action. Validated system ready for regulatory inspection.
- Electronic signatures with dual-factor authentication and password protection
- Immutable audit trails with cryptographic checksums and chain validation
- User authentication and access control with role-based permissions
- System validation and documentation with complete validation packages
- Data backup and recovery procedures with automated backup schedules
- Change control and version management with approval workflows
- System security with encryption at rest and in transit
- Training and documentation for all users and administrators
Exception Management
Configurable exception management and resolution workflows. Track, investigate, and resolve deviations with complete traceability, multi-stage approval routing, and comprehensive reporting.
- Configurable exception rules and thresholds for automated detection
- Exception categorization (Critical, Major, Minor) and prioritization
- Multi-stage approval workflows with electronic signatures
- Exception investigation tracking with root cause analysis tools
- Exception history and comprehensive reporting
- Integration with Laboratory Investigation Reports (LIR)
- Real-time notifications and escalation workflows
Laboratory Investigations
7-stage Laboratory Investigation Report (LIR) workflow for OOS, OOT, OOE, and invalid results. Complete investigation lifecycle with regulatory compliance, immutable context, and comprehensive documentation.
7-Stage Investigation Workflow:
- Preliminary Assessment - Initial evaluation and context capture
- Hypothesis Generation - Develop potential root causes
- Investigation Actions - Retests, resamples, and checks
- Root Cause Analysis - Detailed investigation and analysis
- Impact Assessment - Evaluate impact on product quality
- Conclusion - Final determination and documentation
- Resolution - CAPA and closure
- OOS/OOT/OOE investigation support with automated detection
- Immutable context snapshots preserving original data
- Hypothesis and action tracking with approval workflows
- Retest and resample management with traceability
- Complete audit trail for all investigation activities
Additional Compliance Features
Comprehensive quality and compliance capabilities beyond core requirements
AQL Standards
ISO 2859-1:2017 statistical sampling with comprehensive acceptance criteria and interactive calculator.
Approval Workflows
Configurable multi-stage approval routes with electronic signatures and complete history.
Compliance Metrics
Real-time compliance dashboards with trend analysis and regulatory reporting.
Data Encryption
End-to-end encryption for data at rest and in transit with key management.
Real-Time Monitoring
Continuous compliance monitoring with automated alerts and notifications.
Regulatory Reporting
Automated generation of compliance reports for FDA, EU GMP, and ICH guidelines.
Ready for Regulatory Inspection?
Experience enterprise-grade quality and compliance built into every action. Built for pharmaceutical laboratories that demand regulatory excellence.