Audit-Ready Compliance
Built-in regulatory compliance for ISO 17025, ISO 9001, 21 CFR Part 11, and GLP requirements with complete audit trails and electronic signatures.
Compliance Framework
IMARA LIMS is designed to meet the most stringent regulatory requirements
ISO/IEC 17025:2017
General requirements for the competence of testing and calibration laboratories
ISO 9001:2015
Quality management systems requirements
21 CFR Part 11
FDA regulations on electronic records and electronic signatures
GLP (Good Laboratory Practice)
Quality system for non-clinical safety studies
Built-In Regulatory Support
Every feature designed with compliance in mind
Complete Audit Trails
Every action is recorded with timestamp, user identification, and reason for change. Full traceability from sample registration to final report.
Electronic Signatures
21 CFR Part 11 compliant electronic signatures with multi-factor authentication and signature meaning documentation.
Access Controls
Role-based permissions with granular control over data access, modification, and approval rights.
Data Integrity
ALCOA+ principles built into every workflow ensuring data is Attributable, Legible, Contemporaneous, Original, and Accurate.
System Validation
Pre-built IQ/OQ/PQ documentation packages and validation support for regulated industries.
Training Management
Track personnel qualifications, training records, and competency assessments with automatic access restrictions.
Complete Traceability
Every action in IMARA LIMS is automatically recorded in an immutable audit trail. Reviewers and auditors can easily trace every data point back to its source.
Audit Trail Example
Validation Services
Nuvemite Technologies provides comprehensive validation services including IQ/OQ/PQ documentation for regulated industries. Our validation packages are designed to meet FDA, EMA, and other regulatory body requirements.