LinkedIn Email Phone QA & Validation Support Our engineers and technicians deliver support services within qualification and validation of production processes. As a leading developer of automated production processes, with an in-depth understanding of GMP, ISO 13485 and GAMP5, the AP team is well suited to make a difference in your Medtech project. We can join customer project teams as members for shorter or longer periods of time, or we can be assigned to deliver specific QA tasks. Developing technical documentation and test protocols (SAT, FAT plans) Risk analysis and CE-marking Review, analysis, and re-qualification of processes in order to improve and stabilize production Developing URS (User Requirements Specification) for customers investment projects Review of implemented QA control methods; validate or test? Quality Assurance Design robustness DFM/DFA analysis Review of key processes and critical technologies Test Documentation FAT – Plan, Perform and document SAT – Plan, Perform and document IQ & OQ – Plan, Perform and document URS Support Identifying customer needs Understand and specify critical functions Authoring URS according to GAMP Katarina Willenfort QA Validation +46 733 97 00 07 EMAIL "Automationspartner is one of the leading medtech automation service providers in Scandinavia. The company was founded…" Contact Us Gravörgatan 24 253 60 Ramlösa Sweden Phone +46 42 49 97 900 sales@automationspartner.se Copyright © 2014 - 2021 Automationspartner LinkedIn Email Phone Buffer Systems Packaging Solutions Diagnostic Devices Urinary Catheter Assembly Lines Processes and Technologies Project methodology Operations Support Real-time machine monitoring services Maintenance Services Maintenance Agreements Spare Parts Remote services Training Services On-site Technicians Upgrades and Retrofitting Process Efficiency Improvement Real-time Data Analysis About Us References News Job Opportunities Contact Us Locations