Laboratory Compliance Hub

Navigate complex regulatory requirements with confidence. Our comprehensive compliance guide helps laboratories meet industry standards and regulatory requirements.

ISO 17025

Testing & Calibration Laboratories

International standard for testing and calibration laboratories. Ensures competency, impartiality, and consistent operation.

Worldwide recognition of results

Enhanced credibility

Quality management system

Technical competence validation

21 CFR Part 11

Electronic Records & Signatures

FDA regulation for electronic records and signatures in pharmaceutical, biotech, and medical device industries.

Regulatory compliance

Electronic signature validation

Audit trail requirements

Data integrity assurance

HIPAA

Healthcare Data Protection

Healthcare compliance for laboratories handling patient data and medical testing information.

Patient data protection

Privacy compliance

Security safeguards

Administrative controls

Additional Regulatory Standards

CLIA

Clinical Laboratory Improvement Amendments

US clinical laboratory quality standards

EU GLP

Good Laboratory Practice

European non-clinical safety studies

EPA Guidelines

Environmental Protection Agency

Environmental testing protocols

Why Laboratory Compliance Matters

Data Integrity

Protect your data from corruption, loss, or unauthorized access

Regulatory Approval

Meet requirements for accreditation and regulatory approval

Customer Trust

Build confidence with clients through certified processes

Audit Readiness

Maintain comprehensive records for successful audits

Ready to Achieve Compliance?

LIMSmicro provides the tools and features you need to meet regulatory requirements and maintain compliance across all major laboratory standards.