Quality Management

Quality Management in Healthcare

Quality is one of the most critical aspects of every regulated product. In the healthcare industry, quality management is a multidimensional endeavor that not only verifies that the final product meets expectations but also ensures that all operations adhere to stringent quality assurance policies and procedures.

As a key component of regulatory standards, quality management requires a robust system to control, monitor, and verify all processes and activities affecting product specifications. This ensures that the finished product maintains a high level of quality. All processes, testing, and documentation must follow a consistent plan and comply with current regulations. Every member of an organization involved in product manufacturing, from executives to operators, must understand the quality maintenance plan. Complex and matrixed organizations in the healthcare sector face challenges in strategically meeting increasingly demanding compliance requirements.

SOMA Quality Management Solutions

SOMA's Quality Management team collaborates with clients to develop effective quality management strategies. Our professionals provide customized solutions to specific quality management issues, creating locally focused or company-wide strategies for compliance across pharmaceuticals, biotechnology, diagnostics, cosmetics, and medical devices. We diagnose non-conformities and assist clients with tailored solutions and strategic plans to control and monitor operations involved in producing the final product.

Our services help clients optimize their quality systems, implement new capabilities to meet compliance requirements, and develop strategies to prevent and address enforcement actions.

SOMA Quality Management Services Include:

Document control
Design control
Manufacturing and production processes
Internal process and quality system audits/assessments
Pre-certification audits
21 CFR 820 regulations and compliance
Standard Operating Procedure (SOP) development
Supplier quality and purchasing controls
Labeling consistency and accuracy

SOMA can help create new quality operations models that leverage innovative and integrated technology, streamlining processes, enhancing robustness, and fostering continuous improvement. Our solutions include:

Faster regulatory impact assessments and remediation plans
Lean, simple, and agile Quality Management Systems (QMS)
Comprehensive approaches to managing quality and compliance
Harmonizing, automating, and integrating processes for efficiency
Promoting a quality-centric culture for continuous improvement