



Generate, validate, and archive batch records directly from SAP with automated deviation capture. Reduce manual data entry by 80% and ensure full regulatory traceability.
Automate quality event logging, CAPA workflows, and document version control in alignment with GMP and ISO 13485. Achieve real-time audit readiness across sites.
Automate reports for FDA, EMA, ANVISA, and Health Canada, ensuring 21 CFR Part 11-compliant audit trails. Maintain 100% digital signature integrity and version control.

