The Hauge, Netherlands
+31 623199567
info@mftconsult.nl
We deliver practical QMS solutions that ensure GMP compliance while adapting to your local operations and product lifecycle requirements. Whether you're building a new system or optimizing an existing one, we align every element with your business goals.
Our Quality Management System (QMS) services cover the full spectrum of quality operations—design, auditing, qualification, and continuous improvement. We tailor every step to your unique business needs, ensuring long-term compliance and operational excellence.
We work closely with your team to build a customized Quality Management System aligned with your operational goals and compliant with GMP standards. This includes the development of key documents—policies, SOPs, work instructions, and forms—to establish a traceable and efficient quality framework. We also support risk assessments and environmental and safety evaluations when introducing new products, preparing your facility for evolving pharmaceutical challenges.
Our team conducts internal audits to uncover gaps in your QMS and delivers actionable recommendations for ongoing enhancement. We refine SOPs, strengthen documentation, and implement CAPA strategies to ensure your system keeps pace with regulatory and process changes. Additionally, we provide risk-based assessments to proactively identify and address potential quality risks.
We ensure that your facilities, equipment, and processes are fully qualified and validated according to GMP requirements. Our support spans installation (IQ), operational (OQ), and performance qualifications (PQ), ensuring your systems function as intended and meet product quality standards. We also assist in environmental and safety evaluations during product introductions, maintaining regulatory compliance and operational integrity.
Documentation ensures traceability, accountability, and consistency. It's also a fundamental requirement for audits and regulatory compliance.
Internal audits help detect non-conformities early, allowing teams to take corrective and preventive action before problems escalate.
A QMS should be reviewed regularly — at least annually — and updated whenever there are regulatory changes, process modifications, or audit findings.