MPL (Med Tech, Pharma and Laboratory)
Lösungsfabrik’s MPL division is offering consultating services and support in the areas of Med Tech, Pharma and Laboratory.
ISO 13485 is mandatory for manufacturers of medical devices. It guarantees the security of top-quality products and minimizes risks. We provide you with support when e.g. establishing a quality management system according to DIN EN ISO 13485 or with all related tasks, like conducting internal audits and management reviews for example.
With Pharma, we’re offering the established GMP topics method transfer and method validation according to ICH Q2(R1), expanded by HPLC troubleshooting and HPLC method optimization. We’re taking a first step in supporting GMP compliant documentation in the area of production with product filter validation as new area of expertise.
It is our goal to offer an all-inclusive package regarding documentation activities to pharmaceutical QC laboratories as well as to contract laboratories.
A certification according to ISO 17025 provides test and calibration laboratories with proof of their professional and technical competence, guaranteeing reliable results. We provide you with support establishing a quality management system according to DIN EN ISO/IEC 17025 and separate tasks like management reviews and implementation of internal audits in this area as well.