Qualification and validation
The brief, complete documents that we create for
quality assurance, quality control and production are comprehensible,
consistent, accurate and 100% dependable.
These documents are an indispensable aid for internal inspections and audits by the FDA or by external or local authorities. We know from years of experience precisely what the requirements are for inspections or FDA audits and what the production managers and quality divisions need – and we provide it to you.
Our clients additionally profit from standardised qualification procedures, overviews of the documentation status, integration of the technical specifications into production operations and from the accelerated start-up and deployment of the equipment in question.
Once the system is qualified or validated, the next step is to maintain this status in ongoing operations. We help our clients do this by supporting them in the:
- establishment of configuration and change management procedures
- preparation of SOPs for operation of the system
- training of employees to supervise qualified and validated systems in a manner compliant with GxP
- the organisation and supervision of system reviews and audits