Unlocking XaaS: IT Governance and Software Assurance

SCOTTISH ROOTS, GLOBAL REACH.

Unlocking XaaS:
IT Governance and Software Assurance

SCOTTISH ROOTS, GLOBAL REACH.

Data Integrity

Our senior audit team carries ISACAs coveted CISA, CRISC and CDPSE designations and has performed Data integrity training directly to the US FDA.

Data Integrity

Our Data Integrity Assessment process can quickly identify gaps in your regulated data governance processes.

Governance & Compliance

Our team can customise one, two or a whole suite of ISO27001, ISO9001, and SOC 1/2/3 IT/SQA compliance procedures and policies.

Governance & Compliance

Actively involved with ISPE’s GAMP, ISACA, Scottish Life Science Association, and numerous US trade bodies

Software Assurance & Validation

Our commitment is to maximising your ROI by having your chosen systems up and running, fully validated and fully compliant.

Software Assurance & Validation

Learn how our risk-based computer software assurance based approach reduces timelines, increases ROI and maximizes patient safety.

HIPAA, HITRUST & EHNAC

Readiness assessments and IT Governance Programs are our speciality.

Health Care IT

Our pragmatic risk based approach aligns your Health IT governance strategy with your technology stack

CLOUD-ENABLED BY NATURE

Since 2008 CompliancePath has been at the cutting edge of the life science industry, we’ve been cloud-enabled since day one, and our risk-based approach is perfectly aligned with the new FDA Computer Software Assurance Guidance.

Whether you’re looking to build out your QMS, ISMS, need an audit conducted, or a full SDLC implemented, our team of experts are ready to help.

COMPLIANCEPATH BY NUMBERS

Projects Delivered

+ 0

SaaS Products Launched

Global Offices

Regulatory Actions

OUR SERVICES

Computer Systems Assurance & Validation

Computer System Validation to cover all your GMP, GLP, GCP and QA/QC software applications.

Data Integrity, HIPAA, HITRUST, GDPR & Privacy

Our privacy approach considers GDPR, HIPAA, and CCPA (as applicable), and as of July 2020 we boast the largest CDPSE accredited team in the industry.

Software as a Medical Device

At CompliancePath we specialize in making sure that the inflection point where compliance meets quality is always at the heart of our project delivery.

HIPAA, HITRUST & EHNAC

Our single point governance program ensures that you your policy and privacy frameworks can be harmonized to HIPAA, HITRUST, IEC62304, 21 CFR Part 820 and any area of Health IT or Life Science convergence.

GLOBAL DELIVERY

Today we serve customers all around the world. We are active in China, the Americas, Europe, the UK, Africa, and Australia; we use an ISPE GAMP (c) based, risk-focused, and thoroughly pragmatic approach to ensure that your compliance activities maintain patient safety and are product quality centric.

All of our projects utilize transparent project task management tools, virtual meetings, and remote whiteboarding capabilities to ensure our customers have full visibility as they take their journey along the compliance path.