Security & Compliance Built Into Every Layer of Prolis LIS
Prolis LIS safeguards your laboratory data with enterprise-grade security, ensuring full compliance with HIPAA, CLIA, CAP, and FDA regulations so you can focus on delivering accurate results, not managing risk.
The Cost of Non-Compliance in Clinical Laboratories
Clinical laboratory testing guides more than 70% of all medical decisions. With test results directly impacting patient outcomes, the stakes of regulatory non-compliance extend far beyond fines they affect patient safety and clinical trust.
Loss of Accreditation
Non-compliant laboratories risk losing their CLIA certification and CAP accreditation, effectively shutting down operations and the ability to bill for services.
Legal Liabilities & Fines
Violations of HIPAA, CLIA, or FDA regulations can result in significant financial penalties, lawsuits, and even criminal prosecution for willful neglect.
Increased Regulatory Scrutiny
Laboratories found in violation face more frequent inspections, audits, and corrective action plans that drain resources and disrupt workflows.
Reputation & Trust Damage
A single compliance failure can erode years of trust with referring physicians, patients, and healthcare networks impacting referral volumes and revenue.
Enterprise-Grade Security for Every Laboratory Workflow
Prolis LIS delivers multi-layered security that protects patient data, ensures data integrity, and provides the documentation your laboratory needs to demonstrate compliance during any inspection or audit.
Role-Based Access Controls (RBAC)
Define granular permissions for every user role from lab technicians and phlebotomists to pathologists and compliance officers. Prolis ensures that each user sees only the data and functions they are authorized to access, preventing unauthorized exposure of sensitive patient information.
Electronic Signatures & Authentication
FDA 21 CFR Part 11-compliant electronic signatures with multi-factor authentication ensure that every result approval, record modification, and critical action is digitally signed, verified, and legally attributable to an individual user.
Tamper-Evident Audit Trails
Every action within Prolis LIS from data entry and modification to deletion and user access is logged in an immutable, time-stamped audit trail. These comprehensive records provide complete traceability for regulatory inspections and internal audits.
Data Encryption at Rest & In Transit
Prolis uses AES-256 encryption for data at rest and TLS 1.3 for data in transit, ensuring that Protected Health Information (PHI) remains secure whether stored in the database, transmitted between systems, or accessed by authorized personnel.
Automated Quality Control & Alerts
Built-in QC modules continuously monitor test results against Westgard rules and laboratory-defined parameters. Out-of-range results trigger immediate alerts, preventing release of erroneous results and ensuring compliance with CLIA quality standards.
Automated Compliance Reporting
Generate audit-ready reports aligned with HIPAA, CLIA, CAP, and FDA requirements at the click of a button. Customizable reporting templates, non-conformance tracking, and corrective action documentation keep your laboratory inspection-ready at all times.
Secure Data Archiving & Retention
Prolis LIS maintains compliant data retention policies with long-term, secure archival of laboratory records, test results, and patient data meeting regulatory requirements for record keeping while ensuring rapid retrieval during audits.
Personnel Competency & Training Tracking
Track staff qualifications, training completion, and competency assessments directly within Prolis. Automated reminders for certification renewals and training deadlines help laboratories meet CAP and CLIA personnel requirements without manual oversight.
Comprehensive Compliance Across Every Major Regulatory Framework
Prolis LIS is engineered to help your laboratory meet the requirements of every governing body that oversees clinical laboratory operations all within a single, unified platform.
HIPAA — Health Insurance Portability and Accountability Act
Prolis LIS enforces strict data privacy and security safeguards to protect Protected Health Information (PHI). Role-based access controls, encryption at rest and in transit, and comprehensive audit trails ensure every interaction with patient data is tracked, authorized, and compliant with HIPAA's Privacy and Security Rules.
CLIA — Clinical Laboratory Improvement Amendments
Prolis is designed to meet CLIA's rigorous standards for laboratory testing quality. Automated quality control checks, proficiency testing integration, and standardized test procedures ensure accuracy, reliability, and timeliness of every result whether your lab performs waived, moderate, or high complexity testing.
CAP — College of American Pathologists
With built-in support for CAP accreditation requirements, Prolis LIS helps laboratories maintain inspection readiness at all times. Automated documentation, instrument calibration tracking, personnel competency records, and real-time quality assurance dashboards keep your lab audit-ready year-round.
FDA — 21 CFR Part 11 — Electronic Records & Signatures
Prolis LIS complies with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures. This includes secure user authentication, tamper-evident audit trails, electronic signature workflows, and system validation protocols that ensure data integrity across your laboratory operations.
ISO 15189 — Medical Laboratories — Requirements for Quality & Competence
Prolis supports ISO 15189 compliance by maintaining complete traceability of laboratory processes, from sample receipt to result reporting. Integrated document control, corrective action management, and competency tracking help labs demonstrate the quality management systems required for international accreditation.
GLP — Good Laboratory Practice
For laboratories conducting non-clinical safety studies, Prolis LIS supports GLP compliance through standardized test method management, instrument calibration scheduling, comprehensive data archiving, and chain-of-custody documentation that ensures reproducibility and regulatory acceptance of study data.
Protecting the Accuracy, Authenticity, and Reliability of Every Data Point
Regulatory bodies like the FDA, CLIA, and ISO emphasize that data integrity is the foundation of compliant laboratory operations. Prolis LIS ensures that every piece of data generated, stored, or transmitted by your laboratory is complete, consistent, accurate, and attributable meeting the ALCOA+ principles required by modern regulatory frameworks.
By maintaining the authenticity and accuracy of laboratory data at every stage from order entry and specimen accessioning through analysis, result reporting, and archiving Prolis LIS enables your laboratory to satisfy the most demanding regulatory requirements, including FDA 21 CFR Part 11 for electronic records and signatures.
Key Data Integrity Capabilities
- Access controls restricting system access to authorized personnel only
- Electronic signatures ensuring records are digitally signed and verified
- AES-256 data encryption safeguarding PHI during storage and transmission
- Immutable audit trails recording all data modifications, deletions, and access events
- Automated sample tracking from collection through analysis and disposal
- Standardized test methods ensuring consistent, reproducible results
- Instrument calibration and maintenance schedule management
- Automated QC checks with Westgard rule violations alerting
- Real-time documentation reducing risk of incomplete records
- Version-controlled SOPs with full change history tracking
- Long-term compliant data archiving meeting regulatory retention requirements
- Customizable audit-ready reporting templates for every regulatory body
Seven Steps to Achieve Laboratory Compliance with Prolis
Based on the OIG Model Compliance Plan, Prolis LIS operationalizes the seven essential elements that every laboratory must implement to build a robust, defensible compliance program.
Written Policies, Procedures & Standards of Conduct
Prolis LIS provides centralized document management for all laboratory policies, standard operating procedures (SOPs), and codes of conduct. Version-controlled documents ensure your team always operates under the most current approved procedures a core requirement of CLIA, CAP, and ISO 15189.
Designated Compliance Officer & Committee
Prolis supports the compliance governance structure recommended by the OIG Model Compliance Plan by providing role-specific dashboards for compliance officers and committee members, with real-time visibility into audit status, policy adherence, and corrective actions across all laboratory departments.
Effective Training & Education Programs
Track mandatory training requirements, new-hire orientation completion, and ongoing competency assessments directly within Prolis. Automated notifications ensure no training deadline is missed, helping laboratories meet CAP and CLIA requirements for personnel competency documentation.
Effective Lines of Communication
Prolis facilitates clear communication channels between laboratory departments, clinicians, and compliance teams through integrated messaging, alert systems, and reporting workflows ensuring critical compliance information reaches the right stakeholders in real time.
Internal Monitoring & Auditing
Built-in audit tools allow compliance officers to conduct internal reviews of laboratory processes, user activities, and quality metrics on an ongoing basis. Automated monitoring detects anomalies and potential violations before they escalate into regulatory findings.
Disciplinary Standards & Enforcement
Prolis provides documentation and tracking mechanisms for well-publicized disciplinary guidelines, ensuring that violations of compliance standards are addressed consistently, documented thoroughly, and remediated promptly as required by federal compliance frameworks.
Prompt Response to Violations & Remediation
When compliance violations or system breaches are detected, Prolis enables swift corrective action with automated incident documentation, root cause analysis workflows, and remediation tracking to demonstrate effective response during regulatory inspections.