Manufacturing and trading company seeks quality management software

We are an internationally active manufacturing and trading company in the pharmaceutical industry and are looking for quality management software with a focus on document management, training management, and process management.

We have the following requirements for the software:

• Document management
• Storage of documents
• Work instructions, etc.
• Option of a review and release or approval workflow
• Training management
• Training of documents, instructions, etc.
• Creation of mandatory training courses in the pharmaceutical environment
• Training or qualification matrix
• Process management
• Mapping of processes within the company
• Links to documents
• Option to start a workflow for projects
• Compliance with GMP (Good Manufacturing Practice), ISO 9001, ISO 13485, and FDA (Food and Drug Administration) 21 CFR (Code of Federal Regulations) Part 11
• Web application (read access)
• Interface to SAP system (optional)

Planned software workstations: There are approximately 400 employees in the company, of whom approximately 50-100 require more than read access. Work is carried out in an MS Windows system environment.