Development, implementation as well as consulting and support
Development and implementation of Quality Management Systems (QMS).
Consulting and support of the QMS for and up to certification according to ISO EN 9001.
Consulting and project management for individual modules of the QMS, like:
» Compliance Risk Assessment.
» Compliance Risk Management.
» Document Management (Standards and SOPs).
» Conception, implementation, and follow-up of trainings.
» Coaching of staff and service providers.
» Managing process gaps and inconsistencies (Deviation and CAPA).
» Complaint handling.
» Third Party Management
» Preparation and implementation/participation in self-inspections and audit.
The Quality Management System – Requirements and Objectives for a pharmaceutical company
