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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.

We were in search of a consulting firm to assist us in tailoring our existing quality management system to meet our specific requirements. That’s when we engaged AlvaMed, and I must say, their performance was truly outstanding.

AlvaMed swiftly grasped the intricacies of our unique needs and hurdles, crafting a bespoke solution that perfectly aligned with our objectives. Their adeptness in implementing the new system, conducting internal audits, and delivering design assurance support was not only impressive but also executed seamlessly, adhering to both our schedule and budget constraints.

I recommend AlvaMed to any medical device company in search of a consulting partner. Their competence and commitment are second to none, and they have undoubtedly been instrumental in our success.

Kelly Ashfield

Materna

AlvaMed’s work product was highly regarded by the company’s global quality systems and regulatory leadership.

The global standards remain in effect today and the company has provided the best indication of satisfaction by having AlvaMed continue to support the effort, developing lower level procedures to align with the policy standards.

Large Company QMS Harmonization

CASE STUDY

I would like to extend my thank you to your team for helping us in such a short notice toward Anika’s journey in implementing its very first electronic quality management system. Working with the entire team has been great. Despite multiple challenges along the way, the team was always ready to accommodate.

Quality Assurance Manager

Anika Therapeutics

Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.

President

MedTech Client

Our clients are happy to be references – we are happy to share their contact information when you meet with us.

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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.

Mark Cox

President and Founder

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

Schedule time to meet with Mark Cox.

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