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HIPAA compliance tools for Massachusetts healthcare organizations. Assess readiness, validate BAAs, and ensure patient privacy protection.

FDA 21 CFR Part 11, GMP, GCP compliance assessments for Massachusetts biotech, pharmaceutical, and life sciences companies.

ISO 13485, FDA QSR, EU MDR/IVDR compliance tools for medical device manufacturers in Massachusetts.

IRB, CLIA, GCP, NIH guidelines compliance for clinical research institutions and laboratories in Massachusetts.

NIST CSF, SOC 2, ISO 27001, FedRAMP cybersecurity compliance assessments for Massachusetts organizations.

MA CCC, METRC seed-to-sale tracking, and cannabis security compliance tools for Massachusetts dispensaries and cultivators.
HIPAA compliance tools for Massachusetts healthcare organizations. Assess readiness, validate BAAs, and ensure patient privacy protection.

Comprehensive HIPAA compliance gap assessment for Massachusetts healthcare organizations

Validate BAA compliance with vendors and partners handling PHI

Health IT compliance assessment for electronic health records

Substance use disorder records protection and privacy assessment
FDA 21 CFR Part 11, GMP, GCP compliance assessments for Massachusetts biotech, pharmaceutical, and life sciences companies.

Electronic records and signatures compliance for pharma and biotech

Electronic signature validation for regulated systems

Quality System Regulation compliance for device manufacturers

Drug Supply Chain Security Act assessment and serialization

AI/ML-enabled medical device regulatory pathway assessment

Current Good Manufacturing Practice evaluation for life sciences

Good Clinical Practice evaluation for clinical trials
ISO 13485, FDA QSR, EU MDR/IVDR compliance tools for medical device manufacturers in Massachusetts.

Medical device quality management system assessment

Medical Device Single Audit Program readiness

European Medical Device Regulation assessment

In Vitro Diagnostic Regulation assessment

Unique Device Identification requirements

Medical device risk management assessment

Medical device software development compliance

Medical device usability engineering assessment
IRB, CLIA, GCP, NIH guidelines compliance for clinical research institutions and laboratories in Massachusetts.

Clinical Laboratory Improvement Amendments certification

Institutional Review Board requirements for research

International Good Clinical Practice standards

NIH research compliance and funding requirements

Biosafety in Microbiological and Biomedical Labs

Biospecimen handling and biobank compliance

Scientific data handling and integrity requirements

Institutional Animal Care and Use Committee requirements

Genetic testing and GINA privacy regulations

Clinical trial billing and Medicare coverage analysis

Research conflict disclosure and management

Contract manufacturing organization requirements
NIST CSF, SOC 2, ISO 27001, FedRAMP cybersecurity compliance assessments for Massachusetts organizations.

Service organization trust services criteria assessment

Information security management system certification

NIST CSF risk management and security controls

Federal information security control assessment

Federal cloud security authorization program

Payment card industry data security standard

Health industry cybersecurity practices guidance

Cloud-specific information security controls

Cloud PII protection and privacy controls

Third-party and supply chain risk assessment

Records management and data lifecycle policies
MA CCC, METRC seed-to-sale tracking, and cannabis security compliance tools for Massachusetts dispensaries and cultivators.

Massachusetts Cannabis Control Commission requirements

Cannabis seed-to-sale tracking system compliance

Cannabis testing laboratory requirements

Dispensary and facility security requirements
Massachusetts 201 CMR 17.00, PATCH Act, and state-specific healthcare compliance tools.
GDPR, CCPA, NY SHIELD Act compliance assessments for organizations handling personal data.

EU General Data Protection Regulation assessment

California Consumer Privacy Act assessment

New York data security and breach notification

California medical information confidentiality

Texas medical records privacy compliance

Gramm-Leach-Bliley financial privacy assessment
Telehealth, mobile health apps, and remote patient monitoring compliance for Massachusetts healthcare providers.
Mental Health Parity Act, SAMHSA grants compliance for Massachusetts behavioral health providers.
Healthcare emergency preparedness, pandemic response, and public health reporting compliance tools.

Disease surveillance and reporting requirements

Epidemic response and investigation protocols

Emergency preparedness and disaster planning

Pandemic planning and response compliance
Medicare enrollment, pharmacy licensing, CAP accreditation compliance for Massachusetts healthcare facilities.

Provider enrollment and PECOS compliance

College of American Pathologists laboratory accreditation

State pharmacy board licensing and compliance

ADA and Section 504 healthcare accessibility

Research export compliance and EAR/ITAR
EU AI Act, FDA AI/ML medical device compliance for organizations deploying artificial intelligence.
ISO 9001, AS9100 quality management system compliance for Massachusetts manufacturers.
EPA RCRA, ISO 14001, sustainability reporting compliance for environmentally conscious organizations.
OSHA Lab Standard, EPA hazardous waste compliance for Massachusetts research laboratories.
FDA DSCSA, ISO 28000 supply chain security compliance for pharmaceutical distributors.
OSHA workplace safety, employment law compliance for Massachusetts employers.
GLBA, cyber insurance, professional liability compliance for financial services organizations.
Building codes, healthcare facility compliance for Massachusetts construction and facility management.
Downtime cost analysis, disaster recovery, IT infrastructure compliance for business operations.

MA-specific breach notification requirements

Map and assess protected health information

Validate Business Associate Agreements

Validate clinical trial data security
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