RotaChrom’s instruments are qualified for relevant guidelines (ISPE, PIC, EDQM, etc) and risk assessment through a Factory Acceptance Tests and then a Site Acceptance Test at the customer’s site. (URS, DQ, IQ, OQ and PQ documentation are always included in the standard product package).
RotaChrom supports your cleaning validation program by providing intelligent hardware components, smart surface materials, well-designed maintenance and cleaning documentation in order to minimize cross-contamination of your products.
Software applications and “design-freeze” computerized systems involved in development and scale up are validated according to the GAMP5 framework.
RotaChrom’s subject matter experts are highly versed in state of the art QbD (Quality by Design) and Design Space (DS) concepts and principles. Your technology transfer protocols and reports will be well-designed, comprehensive, eloquent, and will support your company’s uncompromising compliance during your vendor audits and regulatory inspections.