Compliance & Quality Systems
ProMind Solutions LLC – Your trusted partner in building smarter, stronger, and future-ready laboratories.
At ProMind Solutions LLC, we provide comprehensive compliance consulting services to ensure laboratories meet and maintain the highest regulatory standards. Whether you are a new facility seeking certification or an established lab preparing for inspection, our expertise helps you stay compliant, audit-ready, and aligned with industry best practices.
| Compliance Area | Description of Service |
|---|---|
| Regulatory Certification Support | Guidance for CLIA, CAP, and FDA certification, renewals, and inspections; mock audits and readiness assessments. |
| Policy & SOP Development | Creation and implementation of Standard Operating Procedures tailored to each lab’s scope of testing. |
| Quality Management Systems | Establishing and maintaining QA/QC programs, validation protocols, and proficiency testing. |
| Audit & Inspection Readiness | Comprehensive preparation for internal and external inspections, including corrective action planning. |
| HIPAA & Data Privacy | Ensuring compliance with HIPAA standards for PHI handling, de-identification, and secure data management. |
| Training & Competency | Staff education on regulatory standards, compliance responsibilities, and ongoing competency assessments. |
| Risk & Gap Assessments | Identifying compliance gaps, developing CAPA (Corrective and Preventive Action) plans, and minimizing inspection risks. |
✅ Inspection-Ready – Prepare confidently for CLIA, CAP, or FDA audits.
✅ Compliance First – Every system and SOP designed to meet strict regulatory standards.
✅ Sustainable Solutions – Ongoing support to maintain compliance long-term.
📑 Regulatory Certification Support
- Guidance for CLIA, CAP, and FDA certification and renewals
- Preparation for inspections and audits with mock reviews and readiness assessments
- Assistance in completing applications, documentation, and corrective action plans
🧾 Policy & Procedure Development
- Creation of Standard Operating Procedures (SOPs) tailored to your lab’s scope of testing
- Documentation systems to ensure traceability and accountability
- Ongoing updates to reflect evolving regulations and industry standards
✅ Quality Management Systems
- Implementation of QA/QC programs for consistent, accurate test results
- Validation and verification protocols for new assays, equipment, and workflows
- Proficiency testing support to maintain regulatory approval
👩⚕️ Staff Compliance Training
- Training programs to ensure staff understand and follow compliance standards
- Competency assessments to meet CLIA/CAP personnel requirements
- Ongoing education to adapt to new compliance regulations
🔍 Risk & Gap Assessments
- Detailed audits to identify compliance gaps and areas of improvement
- Risk management strategies to prevent deficiencies during inspections
- Corrective and preventive action (CAPA) plan development