Medical Technology

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 ZEISS GUARDUS entirely meets all these requirements:

“In order to comply with the burden of proof required by the FDA, as well as by other authorities, we needed a centralized data pool. Only in this way could we provide the Quality and production management within a FDA regulated Environment Challenges in health care perfect supporting documentation concerning the materials used in each step of the manufacturing process of each filter”

Michael Schwanz

Project Manager/Service-Center IT

Gambro Dialysatoren GmbH

GUARDUS MES for Medical Technology
  • 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
  • Detailed authorization concepts including digital signatures
  • Execution of product and process audits
  • Company-wide online performance indicators and key performance indicators (KPI)