Driftpin Consulting
Driftpin Consulting specializes in helping life sciences organizations navigate compliance, regulatory frameworks, and system validation. They focus on ISO certifications, GxP compliance, system implementation, and strategic guidance, leveraging expertise in AI, system validation, and change management to ensure operational excellence and regulatory compliance. Led by Kevin Shea, they serve pharmaceutical, biotechnology, CROs, and GxP software developers, offering tailored solutions and collaborating with leading industry partners.
Industries
Nr. of Employees
small (1-50)
Driftpin Consulting
Warminster, Pennsylvania, United States, North America
Services
Gap analyses, quality system design, and program support to prepare organizations for ISO 9001 and ISO 27001 certification.
End-to-end implementation for R&D and clinical systems including vendor evaluation, integration, data migration, documentation, and lifecycle management with validation support.
Computer system validation services including validation planning, UAT, PQ, and documentation to demonstrate compliant system performance.
Advisory and strategy services for integrating AI into GxP-regulated processes, including model-driven predictive maintenance, process optimization, and compliance-aligned deployment practices.
Change management programs that align people, processes, and technology, with training to support validated system and AI adoption.
Two-hour consultation engagements to provide targeted guidance on regulatory compliance, system implementation, and validation planning.
Gap analyses, quality system design, and program support to prepare organizations for ISO 9001 and ISO 27001 certification.
End-to-end implementation for R&D and clinical systems including vendor evaluation, integration, data migration, documentation, and lifecycle management with validation support.
Computer system validation services including validation planning, UAT, PQ, and documentation to demonstrate compliant system performance.
Advisory and strategy services for integrating AI into GxP-regulated processes, including model-driven predictive maintenance, process optimization, and compliance-aligned deployment practices.
Change management programs that align people, processes, and technology, with training to support validated system and AI adoption.
Two-hour consultation engagements to provide targeted guidance on regulatory compliance, system implementation, and validation planning.
Expertise Areas
- Regulatory compliance for GxP/GMP environments
- Computer system validation (CSV) and software validation
- ISO 9001 and ISO 27001 certification and QMS/ISMS design
- System implementation and integration for R&D and clinical platforms
Key Technologies
- AI-driven analytics and predictive models
- Computer system validation (CSV) methodologies
- GAMP 5 and risk-based validation approaches
- ISO 9001 / ISO 27001 frameworks
News & Updates
Seamless compliance for clinical systems.
Reducing risks with innovative strategies.
ISO Certification Leadership
Successfully directed ISO 9001 and ISO 27001 certification initiatives, strengthening quality and security systems.
AI-Driven Compliance
Guided organizations in leveraging AI for Computer System Validation (CSV), risk management, and operational efficiency.
Regulatory Expertise
Developed and implemented Quality Management Systems (QMS) tailored to industry best practices.
Collaborative Transformation
Empowered teams to align with compliance goals while fostering innovation.
Seamless compliance for clinical systems.
Reducing risks with innovative strategies.
ISO Certification Leadership
Successfully directed ISO 9001 and ISO 27001 certification initiatives, strengthening quality and security systems.
AI-Driven Compliance
Guided organizations in leveraging AI for Computer System Validation (CSV), risk management, and operational efficiency.
Regulatory Expertise
Developed and implemented Quality Management Systems (QMS) tailored to industry best practices.
Collaborative Transformation
Empowered teams to align with compliance goals while fostering innovation.