Compliance Management
Achieve compliant, traceable, and audit-ready digital operations across manufacturing and quality. The platform supports FDA 21 CFR Part 11, GxP, and ALCOA+ through secure data management, electronic signatures, audit trails, timestamps, and role-based access.
What it covers
The core capabilities included in this module.
Secure data management
Validated data integrity controls aligned with ALCOA+ — attributable, legible, contemporaneous, original, accurate, and more.
Electronic signatures
Part 11–compliant signatures embedded into approvals, reviews, and batch release.
Audit trails & timestamps
Tamper-evident chronology of every record change, signature, and approval event.
Deviation & change control
Standardized approvals, SOP adherence, deviation management, and controlled documentation processes.
CAPA
Systematic root-cause investigation, corrective action tracking, and preventive measures to avoid recurrence.
Inspection readiness
Pull complete batch dossiers, audit trails, and training records on demand.
Key benefits
- End-to-end traceability across the enterprise
- Reduced manual effort and compliance risk
- Operational transparency for QA and leadership
- Stronger governance across functions
- We leverage AI to streamline CAPA processes by analyzing findings, identifying trends, supporting root cause investigations, and accelerating SOP and process updates.
- Faster implementation of CAPA findings by updating SOPs, workflows, and related system transactions in a controlled and compliant manner.
Compliance & data integrity
Directly supports FDA 21 CFR Part 11, GxP, ALCOA+, EU GMP Annex 11, and ICH Q10 expectations on data integrity, electronic records, and quality oversight.
Ready to see compliance management in action?
Book a tailored walkthrough with our manufacturing technology specialists.