Smart Pharma Solutions
Smart Pharma Solutions specializes in integrating Information Technology and GxP compliance expertise to facilitate regulatory compliance of IT systems and enhance business efficiency. Their mission is to be the preferred informatics compliance partner for companies developing cures to improve human life, offering smart solutions tailored to the needs of the life sciences industry.
Industries
Nr. of Employees
small (1-50)
Smart Pharma Solutions
San Francisco, California, United States, North America
Products
GxP-compliant cloud hosting platform
Secure cloud hosting platform designed to support GxP hosting requirements and reduce effort for qualification and compliance of regulated systems.
Cloud compliance services bundle (ClaaS)
Packaged professional services covering cloud provider selection, migration planning, compliance strategy, quality plan development and qualification deliverables for cloud deployments.
Secure data vault for regulated data exchange
Secure data exchange vault for transferring regulated data between partners while maintaining data integrity and access controls.
GxP-compliant cloud hosting platform
Secure cloud hosting platform designed to support GxP hosting requirements and reduce effort for qualification and compliance of regulated systems.
Cloud compliance services bundle (ClaaS)
Packaged professional services covering cloud provider selection, migration planning, compliance strategy, quality plan development and qualification deliverables for cloud deployments.
Secure data vault for regulated data exchange
Secure data exchange vault for transferring regulated data between partners while maintaining data integrity and access controls.
Services
End‑to‑end cloud compliance services including cloud provider selection, hosting model advisory, architecture and solution design, migration roadmap, cloud quality management, compliance strategy and project management for GxP systems.
Secure cloud hosting platform designed to meet GxP hosting needs and support qualified, validated deployment of regulated systems.
Managed validation services including SDLC alignment, policy development for system validation and data integrity, execution of validation documentation and validation summary reporting.
Advisory and operational support to set up laboratory informatics centers of excellence, governance, policies and procedures to keep laboratory systems and instruments inspection ready.
Development of IT quality policies, SOPs and templates; support for deviations, CAPA and investigations; ICH quality system alignment for software and IT.
Support to prepare for and manage regulatory inspections of information systems, including preparing responses to observations and executing remediation plans.
End‑to‑end cloud compliance services including cloud provider selection, hosting model advisory, architecture and solution design, migration roadmap, cloud quality management, compliance strategy and project management for GxP systems.
Secure cloud hosting platform designed to meet GxP hosting needs and support qualified, validated deployment of regulated systems.
Managed validation services including SDLC alignment, policy development for system validation and data integrity, execution of validation documentation and validation summary reporting.
Advisory and operational support to set up laboratory informatics centers of excellence, governance, policies and procedures to keep laboratory systems and instruments inspection ready.
Development of IT quality policies, SOPs and templates; support for deviations, CAPA and investigations; ICH quality system alignment for software and IT.
Support to prepare for and manage regulatory inspections of information systems, including preparing responses to observations and executing remediation plans.
Expertise Areas
- Cloud compliance for regulated systems
- Computer systems validation (GxP)
- Laboratory informatics and LIMS/ELN/CDS support
- IT quality systems and ICH-aligned documentation
Key Technologies
- Cloud computing for regulated workloads
- GxP-compliant cloud hosting
- Validation protocols (IQ/OQ/PQ)
- Laboratory information management systems (LIMS/ELN/CDS)