Quality & Compliance

Compliance Built Into Every Action

21 CFR Part 11 by design—with ALCOA+ principles, tamper-evident audit trails, and investigation workflows built into every operation.

Compliant
21 CFR Part 11
9/9
ALCOA+ Principles
Configurable
Audit Retention
7-Stage
Investigation Stages

ALCOA+ Data Integrity

All nine principles enforced throughout the system—so data stays attributable, enduring, and inspection-ready.

A

Attributable

Every action is attributed to a specific user with complete user context

L

Legible

All data is readable, clear, and permanently recorded

C

Contemporaneous

Data is recorded at the time of the operation with precise timestamps

O

Original

Source data is preserved with immutable audit trails

A

Accurate

Data validation and integrity checks ensure accuracy

C

Complete

No data loss or gaps in the audit trail

C

Consistent

Standardized data formats and validation rules

E

Enduring

Permanent audit trail with 7-year retention

+

Available

Audit information is accessible and retrievable

Centralized Audit Trails

Tamper-evident audit trails for every CRUD operation—complete context, cryptographic integrity, and 7-year retention.

  • SHA256 checksums for tamper evidence
  • User attribution with session tracking
  • Before/after value tracking on changes
  • Cross-table queries and integrity verification
  • 7-year retention with automated cleanup
Audit Dashboard showing filterable audit records with table name, operation, user, timestamp, and field changes

21 CFR Part 11 Compliance

Electronic signatures, secure audit trails, and data integrity built in—ready for regulatory inspection.

  • Electronic signatures with dual-factor auth
  • Immutable trails with chain validation
  • RBAC and access control
  • Validation documentation packages
  • Encryption at rest and in transit
ALCOA+ compliance validation score with audit history and related records for procedure runs

Exception Management

Detect, investigate, and resolve deviations with full traceability and multi-stage approval routing.

  • Configurable rules and automated detection
  • Critical / Major / Minor prioritization
  • Multi-stage approvals with e-signatures
  • Root cause tools and CAPA tracking
  • Escalation and LIR integration
Exception details panel showing result condition failure, severity, status, and approval notes
New LIR form showing initiation fields, workflow stages, and create investigation action

Laboratory Investigations

Structured LIR workflow for OOS, OOT, OOE, and invalid results—from preliminary assessment through CAPA closure.

  1. 1Preliminary Assessment — Context capture
  2. 2Hypothesis Generation — Potential root causes
  3. 3Investigation Actions — Retests and checks
  4. 4Root Cause Analysis — Detailed investigation
  5. 5Impact Assessment — Product quality impact
  6. 6Conclusion — Final determination
  7. 7Resolution — CAPA and closure

Additional Compliance Capabilities

Quality tooling beyond the core audit, Part 11, and investigation stack.

AQL Standards

ISO 2859-1:2017 statistical sampling with acceptance criteria and calculator support.

Approval Workflows

Configurable multi-stage routes with electronic signatures and full history.

Compliance Metrics

Dashboards with trend analysis and regulatory reporting views.

Data Encryption

Encryption at rest and in transit with managed keys.

Real-Time Monitoring

Continuous monitoring with automated alerts and notifications.

Regulatory Reporting

Reports aligned to FDA, EU GMP, and ICH expectations.

Ready for Regulatory Inspection?

See how compliance is built into every action—not bolted on after the fact.

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