Bluciela-Lifesciences SAS, retained Client Consultancy Service Program

Retained Client Consultancy Service Programs

Retained Client Consultancy Service Programs

This consultancy will offer Retained Client Consultancy Service Programs as listed below :

  • Outsource your Audits/Supplier Management – paper, remote, on-site, 3rd party
  • Ad hoc email inquiries & quick consultations
  • Risk assessments – on request
  • Organizational assessments
  • Data Integrity Assessments
  • Filing compliance gap assessments
  • Critical Incident Management – on request
  • Communication: Agreed meetings scheduled as required
  • Assessments
  • Deviation reviews 
  • Procedures

Management, strategy

  • Out-source your costly internal activities while enduring operational excellence & efficiency

Organizational assessments

  • Have an Organisation Fitness assessment to find out how well your organisation is working, procedures are simple and clear, staff adequately trained and educated.

Filing compliance gap assessments

  • Check that your products being made in multiple locations are compliant with the filed process. Over the years & without comprehensive Change Control processes can drift causing non-compliance and potential recalls in one site or more.
     
  • KPIs are they showing failing trends without corrective action? A detailed assessment looking for repeated failures, lack of root causes and poor CAPA.

Data management systems

  • Ensure your paper systems are fully controlled, not photocopiable and reconcilable.
  • Ensure your e-data is secure and fully controlled with
    Access control
    Secure Back-up and recovery
    Time management
    Audit trail - well designed - with critical changes visible
    All critical e-data, validated CPPs, are collected, stored and trended
     

IT vendor assessments

  • CSV audits of vendors
  • Ensuring Quality Management System in place
  • Software programming standards in place 

Let the experts be available for you as & when you need them or let them manage your system for you.

Contact us