Build Systems That Keep You Audit-Ready

Compliance shouldn't be about scrambling before inspections. The right systems make audit-readiness a natural byproduct of daily operations.

Common Compliance Challenges

Documentation Gaps

Missing or incomplete records that create findings during inspections.

Audit Trail Holes

Unable to prove who did what, when, especially for result changes.

QC Documentation

Inconsistent QC review processes and documentation.

Training Records

Difficulty proving staff competency at the time of testing.

Compliance Frameworks We Support

CLIA

Personnel, QC, QA, proficiency testing

CAP

Laboratory accreditation standards

HIPAA

Privacy and security of PHI

21 CFR Part 11

Electronic records, e-signatures

ISO 17025

Testing lab competence

State Regulations

State-specific requirements

Our Approach to Compliance

Gap Assessment

We evaluate your current state against applicable requirements. Not a generic checklist—a targeted assessment of your specific gaps.

System Design

We design workflows and system configurations that generate compliant documentation automatically as part of normal operations.

Audit Trail Implementation

Complete, tamper-proof audit trails that capture who, what, when, and why for every significant action.

Training & Competency

Systems that track training completion and competency assessment, linked to test permissions.

Continuous Monitoring

Dashboards that show compliance status in real-time, not just during inspection prep.

Typical Outcomes

Inspection prep time
Before: 2-4 weeks of scrambling
After: Hours of review
Documentation completeness
Before: Gaps and inconsistencies
After: Complete records
Audit findings
Before: Multiple observations
After: Zero or minor
Staff time on compliance
Before: Reactive, stressful
After: Built into workflow

Ready to Improve Your Compliance Posture?

Start with a gap assessment to understand where you stand. We'll identify specific risks and recommend targeted improvements.

Schedule a Compliance Assessment