QMS Harmonization

Harmonizing quality management systems is an intensive process.

As their businesses expand, companies with multiple QMSs find themselves struggling to adapt to the changing landscape, often duplicating efforts and expending unnecessary resources in order to maintain compliance with evolving health authority requirements. This poses a significant challenge as they often seek to streamline operations by consolidating multiple QMSs into a harmonized system.

Establish a global QMS framework and secure senior management approval. Create a comprehensive Quality Terms Glossary. Select relevant quality system elements for a practical approach to system design. Chart the development of global policies and procedures across the quality system, with a focus on an effective communication plan. Recognize that designing and implementing this system likely requires a multi-year commitment.

Establish dedicated Subject Matter Expert (SME) teams for each QMS element, ensuring representation from all relevant business units. Develop comprehensive policies for each QMS element, outlining clear corporate requirements. Craft a vision map of the interaction of procedures within each QMS element.

Adopt a phased approach to developing global policies and global procedures by establishing two or three QMS element teams simultaneously. Empower team leaders with the necessary tools and resources to effectively guide the content creation process.

Deploy global policies and procedures at the local level. Conduct thorough gap assessments by meticulously comparing existing local procedures and regulatory requirements against global policies and procedures. Address any deviations from global documents in approved implementation documentation. Provide comprehensive training and officially release the harmonized system.

For the past 15 years, AlvaMed has harmonized quality systems at some of the largest lifescience companies.

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QMS Harmonization FAQ's

Streamline your quality management system by eliminating redundancies, standardizing procedures, and adopting a risk-based approach. Empower employees through clear communication, training, and continuous improvement efforts.

To effectively share quality data across an organization, identify the data to be shared, choose a suitable data sharing platform, establish governance procedures, train employees, and monitor the effectiveness of data sharing efforts. Standardize data formats and create a quality data glossary to clearly define each quality data.

To streamline your organization’s ability to respond to regulatory changes, establish a dedicated monitoring team, implement a change management process, utilize regulatory intelligence tools, and collaborate with industry peers. If possible, having technical SMEs participate in the development of revisions to standards can help you influence and prepare for what is coming.

Brian Ludovico

Director of Quality Affairs

Ready to learn more about how AlvaMed can help with QMS harmonization?

Schedule time to meet with Brian Ludovico.