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Quality Management

 The single most significant aspect of every regulated product is the quality, which is a constant necessity within the life sciences industry. In the life sciences industry, quality management is a multidimensional matter. It covers not only the verification that the final finished product is meeting the expectations but also ensures that all operations are governed by quality assurance policies and procedures, and are impeccable. Compromising places the intended product at great risk.

As a component of regulatory standards, quality management requires a system to control, monitor, and verify any process, operation or activity that could affect product conformance. Ensuring that finished life science product meet a high level of quality is a full-scale endeavor. The processes, testing, and documentation behind the products must follow a consistent plan and meet current regulations. Each member of an organization involved in product manufacturing, from executives to operators need to understand the quality maintenance plan.  

STS Quality Management team works in collaboration with clients to guide quality management strategies. Our team of professional offer customized solutions to specific quality management issues and can build locally focused or company-wide strategies for meeting regulations within the life science industry be it a pharma, biotech, diagnostic, cosmetic or medical device. STS Quality Management services will diagnose any nonconformities and assist clients with customized focused solutions with a strategic plan to control and monitor operations that are in process of making final finished product. STS Quality Management team help our clients optimize their quality systems, implement new capabilities to meet compliance requirements, and develop strategies to prevent - and remediate - enforcement actions. We design operating models that address not only the needs of today, but anticipate those on the horizon.

STS Quality Management services cover the full range of quality systems initiatives, including:

  • Internal process and quality system audits/assessments
  • Pre-certification audits
  • 21 CFR 820 Regulations & compliance
  • Document control
  • Design control
  • Manufacturing and production processes
  • Standard Operating Procedure (SOP) development
  • Supplier quality and purchasing controls
  • Labeling consistency and accuracy
  • Complaints, Corrective Action/Preventive Action (CAPA), Adverse Event (AE), Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR) processes and systems

The mission of the Quality function is critical, balancing evolving regulations, complex products and supply chains, and the need to get products to market quickly. Regulators are pushing companies to leverage technology and data to make real-time decisions related to product efficacy and patient  safety. However, life sciences companies, with complex and matrixed quality organizations, are challenged to strategically meet ever more demanding compliance requirements.

By introducing new quality operations models leveraging innovative, integrated technology, processes can be streamlined, made more robust, and continuously improved; cost can be removed; and the enterprise, and a competitive  advantage, secured.
Benefits of transformation include:

  • Conduct faster regulatory impact assessment and remediation plan
  • Employ a lean, simple, and agile Quality Management System (QMS)
  • Develop a protective and holistic approach to managing quality and compliance risk
  • Harmonize, automate, and integrate to gain efficiencies in end-to-end solutions
  • Drive a quality-centric culture that provides continuous improvement