Quality System Implementation

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Intellectt offers advanced solutions for Quality and Compliance in all GxP areas, supporting individual client needs in finding the most effective system to meet regulatory requirements, reach their goals and improve processes.

We have created a network of experts in: Implementation of Quality Management Systems, Support for GxP audits and Computer System Validation. In addition, our team offers training courses on Quality Assurance & Compliance.

  • GxP Training and Audits
  • Quality Agreement Preparation
  • Authoring Quality Manuals and Procedures (SOP)
  • Preparing Work Instructions and Process Maps
  • Device Master Records & Device History Records
  • Design History Files (DHF)
  • CAPA program development and implementation
  • Remediating compliance Support (Warning Letters, Complete Response Letters and Consent Decrees)
  • Risk Assessment
  • Validation Approach