Quality Management Systems

Labnetworx can help Pharmaceutical Organizations and Medical Device manufacturers to set up their IT Quality Management Systems to enable them to be compliant with regulatory agencies such as FDA and EMA. We will provide guidance to the organizations to create SOPs for IT Quality Systems, and can support compliance with the IT Quality Systems throughout the life cycle of IT Systems.

Labnetworx can also help Pharmaceutical Organizations and Medical Device manufacturers to select an appropriate automated Quality Management System for the organization, and support the validation and implementation of the system.

Supplier Assessment and Selection

Critical suppliers must be “controlled.” It is the responsibility of organizations to ensure that subcontractors’ processes meet relevant standards and regulations. This is both good business and a requirement of the FDA, EMA, and other regulatory agencies.

Labnetworx can provide the following services to help with supplier assessment and selection:
  • Risk-based, supplier selection, evaluation, qualification & monitoring program design and SOP reviews 
  • Compliance with FDA, ICH and ISO requirements 
  • Supplier due diligence audits
  • Expert review of quality agreements 
  • Advice on technology tools for supplier and materials quality 
  • Corporate workshops and SOP revisions to incorporate risk-based, streamlined controls

Contact Us

For more information about our audit services, please email at info@labnetworx.com