
Clinical Lab Compliance & Validation Services
Clinical laboratories face stringent regulatory requirements and must maintain high-quality assurance standards to ensure compliance with FDA, CAP, CLIA, and ISO regulations. Lab Assist Inc. provides expert guidance, validation services, and process improvements to keep your lab fully compliant and efficient.

Lab Directorship
✔ CLIA Waived, CLIA, and Medical Director services
✔ Licensed/certified professionals recognized in the U.S.
✔ Support for compliance in laboratory operations

CAP Inspection Preparation
✔ Thorough mock inspections & audit readiness assessments
✔ Detailed gap analysis with corrective action plans
✔ Full guidance on CAP & regulatory expectations

Assay Validation Support
✔ Development of validation plans for new assays
✔ Comprehensive assay validation & compliance
✔ Alignment with FDA, CLIA, and ISO standards

SOP Development
✔ Creation of custom Standard Operating Procedures (SOPs)
✔ SOPs structured to meet ISO, CAP, and CLIA requirements
✔ Support for documentation and training implementation

Competency Development
✔ Development of staff training & competency programs
✔ Ensures compliance with CAP, CLIA, and ISO standards
✔ Custom training to improve operational efficiency

Laboratory & Microbiology Automation
✔ Guidance in lab automation selection & integration
✔ Support for microbiology process automation
✔ Optimization of workflow efficiency with the latest technology

CLIA Licensing Support

Process Improvement
✔ Assistance with CLIA licensing applications & approvals
✔ Ensuring all regulatory requirements are met
✔ End-to-end support for successful licensing
✔ Identification of inefficiencies in lab processes
✔ Tailored solutions to enhance workflow & quality control
✔ Compliance-driven improvements aligned with ISO 9001:2015
Contact
Need expert guidance for your lab’s compliance and validation needs? We’re here to help!
â€(562) 343-0967‬