In the fields of medical technology, pharmaceutical and chemical industry enterprises must meet exigent requirements regarding the documentation of product and process data. Norms such as DIN EN ISO 13485 or 21 CFR Part 11 Food and Drug Administration (FDA) contain clear regulations regarding the implemented IT systems and what they have to provide. Beside the extensive MES-functionalities GUARDUS MES entirely meets all these requirements: 

• Integration of Audit-Trail and Release-Management
• Release of confirmations through ERP/PPS integration
• Traceability (TRA) through all stages of production up to the raw material: Top-Down and Bottom-Up approach
• Compliance with the requirements of DIN EN ISO 13485 and FDA 21 CFR Part 11
• Automated creation of certificates and manufacturer test certificates
• Software which is continuously capable of validation
• Support for Risk Management through homogeneous quality inspections from the product development up to production and delivery.
• Detailed authorization concepts including digital signatures  
• Execution of product and process audits
• Company-wide online performance indicators and key performance indicators (KPI)