Are you confident that your company is compliant with title 21 CFR part 11 and EudraLex annex 11?
We are able to assist companies by running an audit and checking compliance making sure if an inspection happens your company everything will be current to code.
eConsulting helps assess the compliance level by:
- Analyzing the business processes.
- Analyzing validation documents, procedures, and instructions like URS(User Requirements Specification), Risk Assessment, Traceability Matrix, and Validation Plan & Reporting along with the testing documentation.
- Analyzing the documents, procedures, and instructions for the maintenance of the validated state.
- Development of documentation, procedures, manuals for validation as well as implementation and training.
Don't wait for an audit to come. Send us a query and we will ensure your full compliance!