FDA/GMP Compliance

SharePoint Solution

The Alegri solution is a document management system based on Microsoft Office SharePoint Server. It is tailored to the needs of the pharmaceutical industry and conforms with FDA 21 CFR part 11 and GMP Annex 11 regulations.

The Alegri solution is aligned to your company's specific project organization and maps the complete document lifecycle. Complex search algorithms are implemented and documents can be processed simultaneously from different locations without producing multiple copies. 

Regulated document management with SharePoint: The document and content management system from Alegri conforms with U.S. and EU regulations and optimizes the collaboration in companies. 

Alegri offers:

The Alegri solution offers a document management system that is tailored to the pharmaceutical industry and conforms with GMP Annex 11 and FDA 21 CFR Part 11:

  • Mapping of the complete document lifecycle  
  • Alignment with your company's unique project organization  
  • Implementation of complex search algorithms
  • Simultaneous document editing from various locations without multiple copies

Standardized. Qualified. Validated.

  • Standardized approach to qualification and validation from the base infrastructure to the individual solutions
  • SOP, packaging, batch records, complaints and CAPA management
  • Digital GMP archive
  • Structured, project-driven solution that conforms to your company's needs.   
  • Clear, personalized security concept
  • Workflow support across the document lifecycle
  • Automatically generated PDF renditions with all workflow data 
  • …and much more

Consistent. Integrated. Widely accepted.

Our experts can already implement around 60% of the requirements using standard functionality or configurations in SharePoint. The familiar, intuitive world of Microsoft Office increases user acceptance. 

  • Strong CMS characteristics / Intranet integration
  • Use as collaboration platform with Web 2.0 functionalities
  • Workflow capabilities, intelligent forms
  • Seamless integration in business applications (ER ERP, LIMS)

    Discover the fast, straightforward path to FDA/GMP compliance for your company!