US FDA/ EU GMP Compliance

The qualification and validation of all computerized systems influencing patient security and product quality are strictly regulated in the United States (FDA, 21 CFR Part 11) and Europe (GMP Annex 11). These guidelines apply to clinical research companies, the manufacturers of pharmaceutical and medical products as well as the companies supplying them with raw materials, additives, equipment, medical products, hardware and software. Alegri enables you to implement these requirements efficiently while gaining competitive advantages and security through audit compliance.

Alegri supports you with pragmatic approaches to attain and maintain compliance for the IT infrastructure and computerized systems in production, laboratories and clinical research.  

With the Alegri Pharma Lifecycle model, we support you in developing, deploying and operating validated systems. Discover the fast, efficient, pragmatic way to FDA/GMP compliance. Integrate people, processes and information to transform regulatory requirements into a tangible competitive advantage for your company. 

Pharmaceutical and life science companies have successfully audited Alegri numerous times as a supplier.