GXP Systems

Remediation You will benefit from our proven approach to Remediation

Remediate

If you’ve received a warning letter or consent decree, it’s a relief to know that expert help is just a
phone call away. With in-depth knowledge of regulatory guidelines and our superior ability to return systems to a state of validated compliance, we excel at remediation services.

We offer a complete range of remediation services, focusing on improving your operations and
enabling you to stay compliant in an ever-changing and challenging regulatory environment. 

 From initial gap analysis and remediation planning for existing systems to prospective assessments of new systems, our experienced teams will help determine the regulatory relevance and requirements for compliance.

Comprehensive Objectives and Priority Definition
  • Determine the nature of work required
  • Preliminary meetings to address your compliance concerns
  • Review of specific audit finding
  • Scope identification and high-level plan development
Accurate GAP Assessment
  • Determine any underlying issues
  • Analysis of internal or external audit findings, customer complaints or adverse operational events
  • Clarification of core problems and shortcomings
  • Provide GAP assessment report
Formalise Plans
  • Gathering information from your team
  • Formal project plan that identifies timeframes, team requirements, project roles and responsibilities
  • Agreement between all principal stakeholders
  • Complete project visibility
Successful Project Execution
  • Supervision and inspection by our senior management team
  • Internal reporting and on-going quality review of all completed work
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Interested in our solutions?

Contact us now.