Audit-ready. Always.
PureLIMS is built from the ground up for regulated environments — with immutable audit trails, e-signatures, RBAC, and compliance frameworks embedded into every workflow.
Request a DemoCompliance frameworks, built in
Activate the regulatory frameworks your lab needs. Each framework adds the appropriate controls, audit points, and documentation requirements.
21 CFR Part 11 Audit Trails
Computer-generated, timestamped, immutable audit logs at every critical control point. Every record creation, modification, and deletion is captured with user identity, timestamp, reason, and before/after values.
- Computer-generated, timestamped audit entries
- Immutable log storage with integrity verification
- Before/after value capture on every change
- Reason-for-change prompts at critical control points
- Configurable audit scope per workflow and record type
- Export-ready for FDA and ISO inspection
Role-Based Access Control
Fine-grained RBAC with group-based security, record-level constraints, and LDAP/SSO integration. Users see only what their role permits — down to the individual field level.
- Group-based security with inherited permissions
- Record-level access constraints
- Field-level visibility and edit controls
- LDAP and SSO integration for enterprise auth
- Multi-factor authentication for sensitive operations
- Session management with configurable timeout
Electronic Signatures
E-signatures capture identity, timestamp, meaning, and record linkage at every sign-off point. Compliant with 21 CFR Part 11, EU Annex 11, and GxP requirements.
- Identity verification with password re-entry
- Meaning capture (approved, reviewed, rejected)
- Timestamp and record linkage on every signature
- Configurable signature requirements per workflow step
- Signature delegation with audit trail
- Batch signature support for high-volume review
Data Security & Encryption
AES-256 encryption at rest, TLS 1.3 in transit, tenant isolation, and continuous security monitoring. Your data stays secure whether deployed on-cloud or on-premise.
- AES-256 encryption for data at rest
- TLS 1.3 for all data in transit
- Tenant-isolated database architecture
- Continuous vulnerability scanning
- Penetration testing on every major release
- SOC 2 Type II and ISO 27001 alignment
Change Control & Approval
Managed approval workflows for changes to static data, configurations, and critical system settings. Every change is proposed, reviewed, approved, and logged before taking effect.
- Change request workflow with approval routing
- Multi-level approval chains for critical changes
- Automated notifications for pending approvals
- Change history with full before/after comparison
- Rollback capability for configuration changes
- Change freeze periods for audit preparation
Compliance Framework Support
Built-in support for ISO 17025, 21 CFR Part 11, CLIA, GLP/GMP, HIPAA, and EU Annex 11. Configurable compliance profiles let you activate the frameworks relevant to your lab.
- ISO/IEC 17025 accreditation workflows
- 21 CFR Part 11 electronic records compliance
- CLIA proficiency testing integration
- GLP/GMP documentation and training tracking
- HIPAA-aware access controls for clinical data
- EU Annex 11 computerized system validation support
See how PureLIMS handles compliance
Walk through audit trails, e-signatures, and the compliance cockpit with one of our specialists.
Schedule a Demo