GxP-ready from day one.
PureLIMS delivers 21 CFR Part 11 compliance, GLP/GMP documentation, stability study management, and CLIA workflows — in a platform designed for pharmaceutical and clinical laboratory operations.
Request a DemoChallenges you know too well
These are the pain points we hear from labs in your industry — and the reasons they switch to PureLIMS.
21 CFR Part 11 Compliance
FDA requires electronic records with audit trails, e-signatures, and access controls. Retrofitting compliance onto a legacy LIMS is expensive and risky.
GLP/GMP Documentation
Good Laboratory and Manufacturing Practices demand meticulous documentation, training records, and SOP management — all audit-ready at any moment.
Stability Study Complexity
ICH stability studies span months or years with time-point pull schedules, environmental conditions, and trend analysis. Manual tracking leads to missed pulls.
CLIA & Clinical Compliance
Clinical labs face CLIA proficiency testing, personnel qualification tracking, and patient data security requirements under HIPAA.
Validation Requirements
Computerized system validation (CSV) for LIMS is expensive and time-consuming. Labs need IQ/OQ/PQ documentation and ongoing validation evidence.
Data Integrity (ALCOA+)
Regulatory agencies expect data to be Attributable, Legible, Contemporaneous, Original, and Accurate. Proving ALCOA+ compliance requires system-level controls.
21 CFR Part 11 Audit Trails
Computer-generated, timestamped, immutable audit logs at every critical control point. Before/after values, user identity, reason-for-change, and record linkage are captured automatically.
- Immutable, computer-generated audit entries
- Before/after value capture on every change
- Reason-for-change prompts at critical points
- User identity with authentication verification
- Configurable audit scope per workflow
- Export-ready for FDA inspection
GLP/GMP Documentation
Built-in support for GLP study management, GMP batch records, SOP management, training tracking, and deviation/CAPA workflows — all linked to audit trails.
- GLP study protocol and report management
- GMP batch record generation and review
- SOP management with version control
- Training record tracking per analyst
- Deviation and CAPA workflow management
- Document control with approval routing
Stability Study Management
Manage ICH stability studies from protocol through trending. Automated pull schedules, condition monitoring, and trend analysis ensure no time point is missed.
- ICH stability protocol management
- Automated time-point pull scheduling
- Environmental condition monitoring integration
- Trend analysis with shelf-life prediction
- Out-of-trend investigation workflows
- Stability report generation per ICH format
Method Validation & Transfer
Manage analytical method validation, transfer, and verification with structured protocols, acceptance criteria, and approval workflows.
- Validation protocol templates per ICH Q2
- Acceptance criteria definition and tracking
- Method transfer protocol management
- Statistical analysis of validation data
- Validation report generation
- Revalidation scheduling and tracking
HIPAA & Patient Data Security
For clinical labs handling patient data, PureLIMS provides HIPAA-aware access controls, encryption, and audit logging — ensuring PHI is protected at every layer.
- HIPAA-aware role-based access controls
- PHI encryption at rest and in transit
- Access audit logging for all patient data
- Minimum necessary access enforcement
- Business associate agreement support
- Breach notification workflow
CLIA & Proficiency Testing
CLIA proficiency testing integration, personnel qualification tracking, and quality indicator monitoring — keeping your clinical lab certification current.
- Proficiency testing sample management
- PT result tracking and grading
- Personnel qualification and competency tracking
- Quality indicator monitoring dashboards
- CLIA inspection readiness reports
- Corrective action tracking for PT failures
Compliance, built in
PureLIMS embeds the regulatory frameworks your lab needs — so you stay audit-ready without extra effort.
Integrates with your stack
Pre-built connectors and standards-based protocols connect PureLIMS to the tools you already use.
See PureLIMS for pharmaceutical labs
Walk through 21 CFR Part 11 compliance, stability studies, and GxP workflows with a pharmaceutical specialist.
Schedule a Demo