Expertise in Quality Management Systems
Quality Management Systems
Ensuring the quality of your pharmaceutical products is achieved in part through a solid Quality Management System (QMS). Normec provides expert support in setting up and/or maintaining your quality management system.
Quality management system as part of GMP
Quality management is a broad concept that involves overseeing and controlling the various activities within an organisation. With a robust quality system in place, life sciences companies can consistently achieve the desired product quality. In practice, this requires a quality management system; a formal framework in which all processes and procedures are documented and standardised.
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Medicine manufacturers are required to maintain a QMS, as part of Good Manufacturing Practices (GMP). Traditionally, a quality management system consisted of paper-based documents, but as the digitisation increases, the process is now digital in most organisations.
Quality management system
Developing and writing procedures, work instructions and related documents according to your requirements. Our technical writers translate current GMP regulations into a well-functioning quality management system.
Optimisation of existing quality systems
Validation and implementation of various digital QMS packages
Operational support in executing your quality processes, such as monitoring deviations, CAPAs and change controls
Normec has its own ISO9001:2015-certified quality system, under which all our testing and validation activities are carried out.
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