ADN is a specialist in risk and requirements management, integrating these into the validation process to provide optimisation, compliance and traceability.
R3 Management, beyond the simple validation of a project, ensures a management of risks and requirements upstream, which naturally results in regulatory compliance downstream.
The consultant is at the heart of ADN, the structure of competency centres is intended to guarantee specialist knowledge for your specific needs.
The main value of ADN is quality by the design: far from the simple concept of validation, ADN proposes validation integrated throughout project, centred on true risk management.
This then makes it possible to optimise the capture and the traceability of the requirements, the principal benefits are:
> Optimization of requirement definition
> Full and optimal test coverage
> And consequently, the optimisation of the deadlines and the costs
From its industry specialisation and years of experience with processes and associated systems, ADN is ideally qualified to assist you in the choice of your solutions and applications.
EU GMP Annex 11 revision for computerised systems !
EU GMP Chapter 4 Revision - documentation (versus records ) from GMP !