Warranties

Responsibility and warranties in the validation process

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

Warranties

We ensure:

Actions agreed on with the client will be performed with the utmost care

Work will be performed in line with applicable laws, regulations and standards

Documents will be prepared and tests performed in compliance with the GDP methodology.

An experienced team, whose members know and understand GxPs and the specificity of the pharmaceutical industry

Responsibility

As a minimum, our accountability towards the client includes:

The scope of our
accountability excludes:

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 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

Find out how our validation experts can support you