Enzyme QMS

Automatically maps QMS processes and documentation to FDA 21 CFR Part 11 requirements, eliminating manual compliance framework setup. Provides pre-built audit trails, electronic signature validation, and regulatory-ready documentation templates.

Provides pre-built compliance frameworks aligned with ICH guidelines and ISO standards (ISO 9001, ISO 13485, etc.). Automatically structures QMS to meet international regulatory requirements across multiple jurisdictions.

Manages the complete supplier qualification lifecycle including audits, assessments, and ongoing performance monitoring. Maintains supplier documentation and ensures compliance with supplier requirements.

Manages electronic batch records and production data with automated data capture from manufacturing systems. Ensures batch records are complete, accurate, and audit-ready.

Provides tools and dashboards to prepare for regulatory inspections by organizing compliance evidence, audit trails, and documentation. Generates inspection-ready reports and tracks inspection findings.

Provides real-time dashboards and reporting on quality metrics, KPIs, and QMS performance indicators. Enables data-driven decision making and trend analysis.

Centralizes all QMS documents in a single repository with automated version control, approval workflows, and access permissions. Eliminates scattered spreadsheets and ensures all users access current, approved documentation.

Automates the entire change management process from request submission through approval, implementation, and verification. Tracks impact analysis, risk assessment, and ensures all changes are documented and traceable.

Manages the complete deviation and corrective/preventive action (CAPA) lifecycle from initial report through root cause analysis, corrective actions, and verification. Provides templates, tracking, and trending analysis.

Seamlessly syncs QMS data with enterprise resource planning systems, LIMS, manufacturing execution systems, and document management platforms. Eliminates manual data entry and ensures consistency across systems.

Enables centralized governance of QMS across multiple manufacturing sites while allowing site-specific customization. Ensures consistent compliance and procedures across the organization while respecting local requirements.

Maintains comprehensive, tamper-proof audit trails of all QMS activities and enforces electronic signatures compliant with FDA 21 CFR Part 11 and eIDAS regulations. Provides forensic-grade documentation for regulatory inspections.

Tracks employee training requirements, completion status, and competency assessments. Ensures personnel are qualified for their roles and maintains training records for regulatory compliance.

Provides tools for identifying, assessing, and monitoring risks to product quality and regulatory compliance. Tracks risk mitigation activities and ensures risks remain within acceptable levels.