FDA/GMP Compliance

Outsourcing, Managed Services, Cloud

Alegri has extensive experience with regulated computerized systems in the fields of complex IT infrastructures, outsourcing and managed services, and cloud environments.

​Use the vast experience of Alegri in complex IT infrastructures, outsourcing and managed services, and cloud environments to support your regulated computerized systems.

Alegri analyzes your computerized systems for outsourcing or cloud readiness including regulatory compliance for the data processed on these systems.

Our offerings:

Analysis of computerized systems for outsourcing and cloud readiness. Building and implementing a migration strategy to an outsourcing or cloud service provider in line with regulatory guidelines.

All success factors from a single source: 

  • Defined work packages to build and implement an outsourcing or cloud strategy for IT systems affected by FDA and GMP regulations
  • Audit and evaluation of outsourcing and cloud service providers
  • Validation and qualification of processes, infrastructure and systems (including all relevant documentation)

Benefits for your business:

  • Optimization potential of outsourcing or cloud strategies for systems affected by US FDA/EU GMP
  • Provider audits prepared and conducted by Alegri professionals
  • Audit compliance with agencies and customers