GxP Compliance

Computerized Systems (Inhouse, SaaS, CROs)

GxP assessment and documentation is a crucial part of implementation and maintenance of computerized systems in regulated industries like pharma, biotech and medical device. With an increasing focus on GxP compliance for computerized systems by the FDA, there is now an opportunity to improve the process for GxP assessment and documentation. This can be relevant when implementing a new IT solution, using an existing IT solution for a new purpose or ensuring inspection readiness.

We can assist you in ensuring GxP compliance and correctly documenting your IT solution(s) in an efficient and structured way. The deliverables include a GxP assessment, a gap analysis report, listing the necessary documentation and all SDLC documentation needed to support the computerized system. 

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You and your organization will benefit from:

  • Staying compliant
  • Reduced time creating and revising documentation
  • Transparent classification of criticality
  • Easier updates and maintenance
  • Easier alignment across systems
  • Inspection ready

Implementation approach and project schedule

 

When assisting clients in optimizing GxP compliance of computerized systems, we usually go through the following 2 phases:

Phase I
A GxP assessment of the computerized system will be created to determine the criticality of the solution. Then an as-is analysis will be executed to identify existing documentation.

Based on this, a report will be created, clearly stating what documentation is needed.

Phase II
All required documentation will be created in close collaboration with the relevant stakeholders. Efficient gathering of input is crucial to ensure timely creation of documentation. The duration of phase II will depend on the complexity and criticality of the system.

GxP compliance
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Your partners in implementation 

 

When choosing HERAX for optimizing the GxP compliance of your computerized system, you will gain a compliant system that is inspection ready. The computerized system will be easier to maintain throughout the lifecycle and if you are verifying the computerized systems used by a CRO, you can gain better trust and compliance here as well.

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