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News

14.06.2018

Continuity with Customised Products

Stability and co-determination further belong to the keystones of the customer philosophy of GUARDUS, which is now part of the ZEISS Group

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24.04.2018

ZEISS Acquires Analysis and Production Management Software Supplier

ZEISS and GUARDUS have announced that the software solutions supplier for computer-supported quality assurance and production management systems based...

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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)
Documents you might be interested in:
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    GUARDUS Solutions AG is a leading supplier in the field of MES-systems. The rigorous process orientation asks for new IT concepts: As many systems as necessary, as few as possible. Fulfilling this demand GUARDUS MES represents an ideal subsystem in the SAP-field.

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    more info

    GUARDUS Solutions AG is an internationally renowned software developer simplifying manufacturing execution and quality management through the implementation of specialized software. With more than 25 years of experience servicing high quality and high responsibility discrete manufacturers, such as Gambro Dialysatoren GMBH & Co. KG, GUARDUS brings the expertise necessary to accelerate processes for forward looking enterprises.

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