CAQ AND MES FOR THE MEDICAL AND PHARMACEUTICAL SECTOR

COMPLIANCE AND SECURITY FOR MEDICAL AND PHARMACEUTICAL PRODUCERS

CASQ-it and WEB.MES are optimally aligned to meet the sensitive demands of the medical and pharmaceutical sector. CASQ-it is a synonym for compliance throughout your processes: From a universal rights concept to a seamless traceability system and to being able to fulfill your documentation and verification commitments with absolute reliability. Whilst WEB.MES keeps the efficiency of your challenging production processes in focus: Through optimized machine utilization, faster response times and decreasing inventory levels.

OUR USER

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INTEGRATED QUALITY MANAGEMENT FOR THE MEDICAL AND PHARMACEUTICAL SECTOR USING CASQ-it

Right from the early development phase, our transparent project planning, detailed risk assessment and powerful inspection planning tools guarantee that your processes are demonstrably sound. The integrated supplier management feature monitors the quality of your suppliers – taking all the available information into consideration during the evaluation process – from the results of your audits to condensed quality indicators. Consistent serial number and material batch tracking guarantees traceability throughout all your production and quality processes. Any modifications to your documents and data can be traced back at any time as electronic signatures and seamless change controls ensure that you are able to provide respective verification documents whenever they are needed. CASQ-it is an integrated tool for standard-compliant and quality-assured processes.

EFFICIENT PRODUCTION MANAGEMENT FOR THE MEDICAL AND PHARMACEUTICAL SECTOR USING WEB.MES

WEB.MES guarantees increasing efficiency and transparency throughout your production processes. During the detailed planning process, numerous automated tasks, such as automatic machine utilization, relieve you of the burden of routine tasks. If it should come to a bottleneck, our simulation feature helps you to identify alternative production scenarios. Our production cockpit also constantly provides you with a transparent overview of your whole production process – consolidating all the respective production information – in real-time. So that you can make the right decisions in the case of any unforeseen events. A detailed and dynamic indicator system supports you in evaluating your production processes. This supplies you with targeted information which allows you to recognize improvement potential and remain capable of taking action at all times.

Highlights

  • Digital signature.
  • Consistent quality assurance even early in the development process thanks to systematic defect prevention strategies.
  • Standard-compliant risk management system.
  • Incoming goods inspection, including an integrated supplier classification system.
  • Batch and serial number tracking throughout all processes.
  • Seamless production history.
  • Control verification and quality documentation through inspection certificates.
  • Comprehensive quality reports generated at the click of a mouse or “fully automatically”.
  • Complaint tracking, including integrated escalation management.
  • Fully-integrated CAPA management system.
  • Integrated auditing standards.
  • Company-wide indicator systems for your quality and production management processes.
  • Warning system for your quality and production management processes: Notification when set warning limits are exceeded.

Standards

CASQ‑it

supports your processes in accordance with the following standards 

  • DIN EN ISO 9001
  • DIN EN ISO 13485
  • FDA
  • GMP

WEB.MES

unites all the latest requirements placed on a modern MES system, including

  • Functional features in accordance with VDI Guideline 5600
  • Production indicators according to VDMA Specification No. 66412