FDA/GMP Compliance

Qualification & Validation

Alegri works with you to ensure fast, efficient compliance with FDA und GMP regulations for computerized systems.

Computerized systems in focus

Alegri applies a risk-based, pragmatic approach to all affected systems, whether they are used and administered centrally in your company or externally in laboratories, production sites or clinical studies. This secures audit compliance and market advantages.

Professional qualification and validation consulting

Alegri offers standard procedures derived from GAMP®5 guidelines to fulfill regulatory requirements in Europe (GMP Annex 11) and the United States. (FDA 21 CFR Part 11).

Our experts adapt the procedure to qualify and validate computerized systems to the unique circumstances and specifications of the respective application and the resulting regulatory requirements. A comprehensive view of the processes in regulated companies lays the groundwork.   

 

Alegri offers:

Validation consulting for computerized systems in line with GAMP® 5. We focus on pragmatic approaches to attain, maintain and ensure future compliance with FDA 21 CFR Part 11 and GMP Annex 11.

All success factors from a single source: 

  • Workshops tailored to your company's requirements
  • Professional consulting in 21 CFR Part 11 / GMP Annex 11 compliance
  • Validation and qualification of processes, infrastructure and systems (including all relevant documentation) 
  • Supplier audits
  • Implementation and training 
  • Validated system operations

Benefits for your business:

  • Individual, pragmatic qualification and validation approaches
  • Optimized processes (e.g. change management) 
  • Agency and customer audits prepared and conducted by Alegri experts
  • More efficient supplier audits