Hello, my name is Tom Koch. I help bio/pharma companies meet regulatory challenges in GxP and data protection/data privacy.

Audits/Vendor Assessment

Inspection Readiness

Data Privacy/Data integrity

Computerized System Validation

Are you meeting the increasing challenges of 3rd party and IT risk management in your clinical research programs?
Are you Implementing good AI practices?
Do you understand your eCRO’s IT and cloud supply chain?
Do you understand your data integrity and inspection risks?

About Tom Koch

WTKoch GCP QA Consulting experience spans clinical, Electronic Records, and Privacy Regulations across multiple clinical trial domains, including Saas, AI, Computerized System Validation and Computer Software Assurance,  risk assessment and IT audit and the application of regulations such as ICH-GCP, 21 CFR Part 11, Annex 11, Annex 12 and the application and assessment of standards and guidance from ISO and GAMP.

Enabling clients to achieve and maintain full regulatory compliance while fully meeting business needs and priorities for over 20 years.

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AREAS OF SPECIALTY

Comprehensive Coverage of all Regulatory Compliance areas

Clinical Systems and Clinical IT Vendor Audits
AI and SaaS 3rd Party Risk Assessment and Management
Data Integrity and eCompliance
Computer System Validation and CSA
ICH, GCP, ISO, and GAMP 5

 

Ensuring Compliance—Enabling Trust