Quality Management Services

Prioritize product quality, data integrity and patient safety.

It’s not enough to just know you need to keep these in mind. We can help you strategize, implement and monitor a quality management framework to check all the boxes.

Quality Management Design

In our industry, filled with complex regulations, changing methodologies, and hybrid environments, formulating a quality strategy focused on patient safety, product quality and data integrity is likely at the core of your organizational priorities.

Through our Quality Management Design services, SQA helps by:

  1. Assessing the corporate level and/or IT specific Quality Management System (QMS) maturity level to determine current state and building a roadmap to get to the desired level

  2. Ensuring that the right sized framework is designed and in place with appropriate processes, standards and templates

  3. Creating data process flow diagrams across functional areas to support data integrity activities

  4. Defining IT SOPs within the QMS to cover all activities from new implementations to operations to retirement of IT systems to support business

  5. Designing a fit-for-purpose QMS with the full product lifecycle in mind – from research and development through trials all the way to commercialization across pharmaceutical, medical device and biotech sectors

  6. Helping organizations implement industry leading practices to reach Continuous Compliance

Quality Management System Implementation

Once the quality framework is built, implementing these practices and executing and monitoring them effectively and efficiently is just as important to ensure patient safety, product quality and data integrity.

SQA helps organizations do this by:

  1. Analyzing and understanding specific needs based on IT and quality strategies and hosting models

  2. Recommending appropriate Quality Management Solutions (eQMS) that are fit-for-purpose

  3. Configuring and optimizing these eQMS tailored to the organization

  4. Validating implementation to ensure systems are operating seamlessly

  5. Providing personnel training for newly implemented solutions

  6. Monitoring the usage of the processes and solutions through periodic reviews

"Thank you again for all that your organization did to support the badly needed changes in testing, agile and process improvements. You and your team did make a difference." - Dan Sheehan, Chief Information Officer, Beacon Health Options

How We Do It

Assess your organization’s current state of quality and devise a go-forward plan through SQA’s subject matter experts.

Leverage our subject matter experts to help execute and implement these plans to achieve patient safety, product quality and data integrity.

Provide local, onsite consultants with industry and regulatory experience to augment your teams and help maintain these important initiatives.

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