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"Documented evidence
which provides a high degree of assurance that a specific
process will consistently produce a product meeting
its pre-determined specifications and quality attributes."
Our Offer
Consulting and staffing support in
- Process validation
- Cleaning validation
- Validation of analytical methods
- Validation of computerized systems
Our Procedure
We provide advise and support in the form of specialist
knowledge and staffing resources in the preparation
of individual validation protocols and in the execution
of the final validation reports, whereby the your company
carries out the validation activities.
Here we also base our work on tried and
tested basic concepts and specially developed checklists,
which we continuously improve according to the latest
developments as well current GMP requirements.
We provide you with basic versions of all
SOPs concerning the validation and, together with you,
adapt them to your individual requirements.
Your Result
Validated processes and systems with all accompanying
SOPs, validation protocols and reports
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Consulting
