The fast, easy, pragmatic way
to FDA/GMP compliance

How you can combine people, processes and information and turn regulatory requirements into your competitive advantage

As part of its strict quality guidelines (e.g. CFR Part 11) for the U.S. market, the FDA now requires a special validation for all IT systems - even for companies based in Europe. This mandate affects pharmaceutical manufacturers, their suppliers (for raw materials, additives, equipment, medical products, hardware, software, etc.), as well as clinical and pre-clinical research companies.

Focusing on the essentials:
Economical validations - even for GAMP 5®

Alegri can help you implement FDA, GMP or GLP requirements effectively to ensure successful audits and secure your competitive advantage. We support you with pragmatic approaches for attaining and maintaining FDA compliance for your IT infrastructure as well as your computer-based production, laboratory and clinical research systems.

The Alegri Pharma Lifecycle Model: Get the support you need to develop, deploy and operate validated systems!

Your contact to Alegri

Dr. Andreas Jabs
Principal Consultant Alegri International Group
Tel. +49 (69) 972 66 98-123

Anwenderbericht

"Corporatewide Documente-Management with SAP and SharePoint at Roche Diagnostics" (German Language)

Case study

"FDA-compliant document management system at Roche Diagnostics"" (German language)

Articles

"FDA compliance for pharmaceutical manufacturers and suppliers" (German language)

Alegri – Microsoft Gold Certified Partner

Alegri International Group is a leading IT consulting company with focus on all Microsoft products. With this specialization Alegri is one of the few Microsoft´s consulting partners, who professionally knows the interaction of the applications. Alegri conceptualizes and realizes professional strategic and operative solutions for large and mid-sized organizations: SharePoint, Search, Dynamics CRM, Lync, Duet, System Center, Cloud Services, .Net., etc.