Responsibility and Warranties

Validation and qualification deal with sensitive stages of manufacturing processes, therefore trust and guarantee of due diligence are of utmost importance. In performing validation and qualification processes, eConsulting assumes responsibility for compliance of the work with the applicable norms, laws and standards, as well as the tests performed or documents delivered.

We ensure:

  • that the actions agreed on with the client will be performed with utmost care,
  • an experienced team, whose members know and understand GxPs and the specificity of the pharmaceutical industry,
  • that the work will be performed in line with the applicable laws, regulations and standards,
  • that the documents will be prepared and tests performed in compliance with the GDP methodology.

Division of roles, responsibilities and accountabilities is in each case determined with the client.

As a minimum, our accountability towards the client includes:

  • accountability for the documents prepared
  • accountability for the documents reviewed
  • accountability for the tests administered
  • accountability for the test results
  • accountability for the meeting of the deadlines for validation works
  • accountability for compliance of the work performed with the applicable laws, regulations and standards

The scope of our accountability excludes:

  • accountability for input documentation for the project, supplied by the client
  • accountability for tests performed solely by the client
  • accountability for the resolution of reported non-conformities
  • accountability for the final approval of validation documentation
  • accountability for final release of the validation object to the manufacturing process.