The refinement and optimization of implementing GMP quality standards requires daily teamwork in different operation units and disciplines. Designing validation and qualification concepts, quality control, quality assurance, manufacturing and IT, work at its best closely together in qualification or validation teams.
When we develop those validation and qualification strategies, we apply the “Lean GMP Validation Concept”. This helps us to follow refinement and reduction but keep to the regulatory expectations.
For our clients, it saves time and money by avoiding unnecessary, time- consuming, and costly validation and qualification activities. In regular project meetings, we develop and optimize the approach on implementation of qualification and validation concepts.
Our validation engineers are equipped with mind and reason to establish the objectives of your validation and qualification strategy.
