Compliance frameworks

42 CFR Part 2 Compliance Assessment

Evaluate compliance with federal regulations protecting confidentiality of substance use disorder patient records

AS9100 Aerospace Quality Management

Evaluate AS9100D aerospace quality management system compliance, building on ISO 9001 with aerospace-specific requirements for safety, reliability, …

Biospecimen Management Best Practices

Evaluate compliance with NCI Best Practices and ISBER guidelines for biospecimen collection, processing, storage, and distribution in research …

BMBL Biosafety Assessment

Evaluate compliance with CDC/NIH Biosafety in Microbiological and Biomedical Laboratories guidelines for safe handling of infectious agents

CA CMIA Medical Privacy Compliance

Evaluate compliance with California Confidentiality of Medical Information Act (Civil Code §56-56.37), covering patient authorization, disclosure …

Cannabis Facility Security Requirements

Evaluate compliance with physical security, surveillance, and access control requirements for cannabis cultivation, manufacturing, and retail …

Cannabis Testing Lab ISO 17025 Compliance

Evaluate compliance with ISO/IEC 17025:2017 requirements for cannabis testing laboratories performing potency, contaminant, and safety testing

Assessment for College of American Pathologists (CAP) laboratory accreditation standards for clinical diagnostic laboratories

CCPA/CPRA Compliance Assessment

Evaluate compliance with California Consumer Privacy Act and California Privacy Rights Act requirements for businesses handling California resident …

CLIA Compliance Assessment

Evaluate compliance with Clinical Laboratory Improvement Amendments for laboratory quality and patient safety

Assessment for Medicare Coverage Analysis and billing compliance for clinical trial services separating research costs from standard care

Assessment for research conflicts of interest management, financial disclosure requirements, and institutional COI policies per PHS and NSF …

Assessment for pharmaceutical contract manufacturing organizations covering cGMP compliance, quality agreements, and third-party oversight

Cyber Insurance Readiness Assessment

Evaluate readiness for cyber liability insurance coverage by assessing security controls, incident response, and risk management practices that …

Assessment for records management, data retention policies, and secure destruction procedures for regulated industries

Employment Law Compliance Assessment

Evaluate federal employment law compliance covering FMLA, ADA, EEOC, FLSA, wage/hour, and workplace rights

EPA Hazardous Waste Management (RCRA)

Evaluate Resource Conservation and Recovery Act (RCRA) compliance for research and biotech labs generating hazardous waste, covering waste …

EPA RCRA Hazardous Waste Compliance

Evaluate Resource Conservation and Recovery Act compliance for hazardous waste generation, storage, treatment, and disposal in laboratory and …

ESG & Sustainability Reporting Readiness

Evaluate readiness for ESG (Environmental, Social, Governance) and sustainability reporting per GRI, SASB, CDP, and TCFD frameworks

EU AI Act Compliance Assessment

Evaluate compliance with EU Artificial Intelligence Act for high-risk AI systems, covering risk management, data governance, transparency, human …

EU IVDR 2017/746 - IVD Compliance Assessment

Evaluate compliance with European In Vitro Diagnostic Regulation 2017/746 for diagnostic tests, companion diagnostics, and laboratory-developed tests …

EU MDR 2017/745 Compliance Assessment

Evaluate compliance with European Medical Device Regulation 2017/745 covering device classification, quality management, clinical evaluation, …

Assessment for EAR/ITAR compliance, deemed export controls, and research security for organizations with foreign national access or international …

FDA 21 CFR Part 11 Electronic Records Compliance

Evaluate compliance with FDA 21 CFR Part 11 requirements for electronic records and electronic signatures in FDA-regulated industries

FDA 21 CFR Part 820 QSR Assessment

Evaluate compliance with FDA Quality System Regulation for medical device manufacturers - the U.S. equivalent of ISO 13485

FDA AI/ML Software as Medical Device (SaMD)

Evaluate FDA AI/ML-based Software as Medical Device compliance per 2021 guidance, covering predetermined/adaptive algorithms, algorithm change …

FDA Drug Supply Chain Security Act (DSCSA)

Evaluate DSCSA compliance for pharmaceutical track-and-trace, serialization, verification, and transaction history requirements

FDA Mobile Health App Compliance

Evaluate mobile medical app compliance with FDA guidance, 21 CFR Part 11, data security, clinical validation, and app store requirements

FedRAMP Authorization Readiness Assessment

Evaluate readiness for FedRAMP authorization to provide cloud services to federal agencies, based on NIST 800-53 security controls

GDPR Compliance Assessment

Evaluate compliance with EU General Data Protection Regulation requirements for processing personal data of EU residents

Assessment for clinical genetic testing laboratories covering CLIA high-complexity testing, FDA LDT oversight, and genetic counseling requirements

GLBA Financial Privacy Compliance Assessment

Evaluate Gramm-Leach-Bliley Act compliance for financial institutions and healthcare organizations handling payment information, covering privacy …

Good Clinical Practice (GCP) Compliance Assessment

Evaluate compliance with international ethical and quality standards for clinical trial design, conduct, and reporting

Good Manufacturing Practice (GMP) Assessment

Evaluate compliance with FDA Good Manufacturing Practice regulations for pharmaceutical and biotech manufacturing quality systems

Healthcare Accessibility (ADA & Section 504)

Evaluate healthcare accessibility compliance covering physical access, effective communication, program access, and auxiliary aids/services per ADA …

Healthcare Emergency Preparedness (CMS Rule)

Evaluate CMS Emergency Preparedness Rule compliance covering emergency plans, policies, communication, training, testing, and integrated healthcare …

Healthcare Payment Card Security Assessment

Evaluate PCI-DSS compliance for healthcare organizations processing credit card payments, covering cardholder data protection, network security, and …

HHS 405(d) Cybersecurity Assessment

Evaluate alignment with Health and Human Services voluntary cybersecurity practices for the healthcare industry

HIPAA Business Associate Compliance

Evaluate compliance with HIPAA Business Associate Agreement requirements for vendors and service providers handling Protected Health Information (PHI)

HITECH Act Compliance Assessment

Evaluate your compliance with the Health Information Technology for Economic and Clinical Health Act

Assessment for Institutional Animal Care and Use Committee compliance, USDA Animal Welfare Act, and PHS Policy for vertebrate animal research

ICH-GCP Clinical Trial Management

Evaluate compliance with ICH E6(R2) Good Clinical Practice guidelines for clinical trial design, conduct, monitoring, and documentation

IEC 62366 Usability Engineering Assessment

Evaluate medical device usability engineering per IEC 62366-1:2015, covering user interface design, formative and summative usability testing, and …

IRB & Human Subjects Research Compliance

Evaluate compliance with 45 CFR Part 46 (Common Rule) requirements for Institutional Review Boards and human subjects research protection

ISO 13485:2016 QMS Assessment

Evaluate compliance with ISO 13485:2016 Quality Management System requirements for medical device design, development, production, and servicing

ISO 14001 Environmental Management System

Evaluate ISO 14001:2015 environmental management system compliance, covering environmental policy, planning, implementation, monitoring, and continual …

ISO 14971 Risk Management Assessment

Evaluate medical device risk management per ISO 14971:2019, covering risk analysis, risk evaluation, risk control, and post-production risk monitoring …

ISO 27001:2022 ISMS Assessment

Evaluate alignment with ISO/IEC 27001:2022 requirements for establishing, implementing, maintaining, and continually improving an Information Security …

ISO 27017 Cloud Security Assessment

Evaluate cloud security controls per ISO/IEC 27017:2015 for cloud service providers and cloud customers, covering shared responsibility, data …

ISO 27018 Cloud Privacy Assessment

Evaluate cloud privacy controls per ISO/IEC 27018:2019 for protection of Personally Identifiable Information (PII) in public cloud environments, …

ISO 28000 Supply Chain Security Management

Evaluate ISO 28000:2022 supply chain security management system compliance, covering security risk assessment, threat mitigation, and resilience …

ISO 62304 Software Lifecycle Assessment

Evaluate medical device software development per ISO 62304:2006/AMD1:2015, covering software safety classification, development processes, risk …

ISO 9001 Quality Management System

Evaluate ISO 9001:2015 quality management system compliance, covering leadership, planning, support, operation, performance evaluation, and continual …

Lab & Facility Building Code Compliance

Evaluate building and fire code compliance for laboratory, cleanroom, and BSL facilities covering construction, life safety, egress, and specialized …

MA Cannabis Control Commission Compliance Assessment

Evaluate compliance with Massachusetts Cannabis Control Commission regulations (935 CMR 500.000) for cultivation, manufacturing, testing, and retail …

MA PATCH Act Compliance Assessment

Evaluate compliance with Massachusetts PATCH Act requirements for preventing opioid diversion and protecting controlled substances in healthcare …

MDSAP Readiness Assessment

Evaluate readiness for Medical Device Single Audit Program certification covering FDA, Health Canada, TGA, PMDA, and ANVISA requirements in one audit

Medicare/Medicaid Enrollment Compliance Assessment

Evaluate compliance with CMS provider enrollment and revalidation requirements for Medicare and Medicaid participation

Mental Health Parity & Addiction Equity Act (MHPAEA)

Evaluate compliance with Mental Health Parity and Addiction Equity Act covering insurance coverage equity, treatment limitations, and disclosure …

METRC Seed-to-Sale Tracking Compliance

Evaluate compliance with METRC seed-to-sale tracking system requirements for cannabis establishments in regulated states

NIH Recombinant DNA Guidelines Assessment

Evaluate compliance with NIH Guidelines for research involving recombinant or synthetic nucleic acid molecules

NIST 800-53 Rev 5 Assessment

Evaluate compliance with NIST SP 800-53 Revision 5 security and privacy controls for federal information systems and organizations

NIST Cybersecurity Framework 2.0 Assessment

Evaluate cybersecurity maturity using NIST CSF 2.0 core functions: Govern, Identify, Protect, Detect, Respond, Recover - designed for all sectors …

NY SHIELD Act Compliance Assessment

Evaluate compliance with New York Stop Hacks and Improve Electronic Data Security (SHIELD) Act, covering data security safeguards, breach …

OSHA Lab Standard Compliance (29 CFR 1910.1450)

Evaluate Occupational Safety and Health Administration (OSHA) laboratory standard compliance for research and clinical labs working with hazardous …

OSHA Workplace Safety Compliance

Evaluate OSHA general industry workplace safety compliance covering hazard communication, recordkeeping, emergency action plans, and worker protection

Outbreak Investigation & Infection Control

Evaluate outbreak investigation and infection control readiness covering contact tracing, infection prevention, public health coordination, and …

Pandemic Response & Infectious Disease Preparedness

Evaluate pandemic preparedness covering surge capacity, infection control, PPE stockpiling, crisis standards of care, and workforce protection

PCI-DSS v4.0 Compliance Assessment

Evaluate compliance with Payment Card Industry Data Security Standard v4.0 requirements for organizations that store, process, or transmit cardholder …

Assessment for state pharmacy board licensure and DEA controlled substance registration for pharmacies and research facilities

Professional Liability Insurance Readiness

Evaluate readiness for professional liability insurance (E&O, D&O, malpractice) by assessing risk management practices, documentation, and governance

Public Health Reporting & Surveillance

Evaluate public health reporting compliance covering disease surveillance, immunization registries, syndromic surveillance, and vital statistics …

Remote Patient Monitoring (RPM) Compliance

Evaluate remote patient monitoring program compliance covering CMS reimbursement, device accuracy, data transmission security, and clinical workflows

Research Data Management & FAIR Principles

Evaluate research data management practices including FAIR principles (Findable, Accessible, Interoperable, Reusable), data integrity, and regulatory …

SAMHSA Grant Compliance & Reporting

Evaluate SAMHSA grant compliance covering federal requirements, financial management, data reporting, and program evaluation for substance abuse …

SOC 2 Type II Readiness Assessment

Evaluate readiness for SOC 2 Type II audit based on AICPA Trust Services Criteria for security, availability, processing integrity, confidentiality, …

Telehealth & Telemedicine Compliance

Evaluate telehealth program compliance covering state licensure, prescribing rules, HIPAA security, informed consent, and reimbursement requirements

Texas Medical Privacy Compliance

Evaluate compliance with Texas Health & Safety Code Chapter 181 (Medical Records Privacy), covering protected health information, patient consent, …

UDI Compliance Assessment (FDA & EU)

Evaluate Unique Device Identification compliance for FDA (21 CFR Part 801/830) and EU MDR (Article 27), covering UDI assignment, labeling, …

Assessment for third-party vendor security, risk assessments, business associate agreements, and vendor lifecycle management