IF YOUR CONSULTANT DOESN'T WEAR A KILT, CAN YOU TRUST THEM?
SCOTTISH ROOTS, BAJAN BRILLIANCE, GLOBAL REACH.
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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.
Read MoreGovernance & 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
Read MoreSoftware 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.
Read MoreHIPAA, 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
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OUR SERVICES
Computer Systems Assurance & Validation
ISO & SOC Certification Prep
IT Governance & Compliance
SaaS Commercialization
Data Integrity, HIPAA, HITRUST, GDPR & Privacy
Validation Accelerator Packages
Software as a Medical Device
HIPAA, HITRUST & EHNAC
Computer Systems Assurance & Validation
Computer System Validation to cover all your GMP, GLP, GCP and QA/QC software applications.
ISO & SOC Certification Prep
ISO27001/ISO9001 and SOC2 support to deliver end to end controlled document and SOP set to meet certification requirements.
IT Governance & Compliance
Services inclusive of Security Control Preparation/Audits/Training by our ISACA accredited CISA, CRISC, and CDPSE team.
SaaS Commercialization
CompliancePath is unique among our peers and haas the experience to help you to commercialize your software.
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.
Validation Accelerator Packages
CompliancePath is the trusted validation acceleration partner for some of the biggest names in quality software.
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.
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.
- Compliance/ Validation/ Quality as a Service
- Cost efficient and transparent
- Plug-and-play compliance with monthly fixed costs
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.