The U.S. Food and Drug Administration (FDA) and other global regulatory authorities enforce practices that require companies to integrate regulatory compliant Quality Management Systems (QMS) and risk management approaches into their operational processes. The goal is to integrate quality by design (QbD) into their products and make products safer for patients.
 
A well-designed QMS, when combined with manufacturing processes and product knowledge, supports increased safety and continuous process improvements. It also provides the necessary framework for implementing QbD practices that regulators are seeking. 
 
Furthermore, a QMS enables regulators to see the internal workings of an organization and assess its overall compliance with GxP regulations.
 
With decades of industry experience, USDM’s QMS experts will guide you through the design, configuration, implementation, and validation of a complete quality management system integrated with your enterprise applications.

Maintaining Quality Management

Your QMS is an area of focus for the FDA’s Quality Systems Inspection Techniques (QSIT). USDM identifies and measures your state of compliance to FDA regulations across all areas of operation within your plant or facility.
 
Further, USDM has solutions for maintaining continuous compliance of your QMS, regardless of the technology. Learn more about USDM’s Cloud Assurance managed service.

ISO 9001 Certified Quality Solutions

Modern QMS practices are based on International Organization for Standardization and International Electrotechnical Commission (ISO/IEC) 9001 standards. 
 
While regulatory requirements for Good Laboratory Practices (GLP), Good Clinical Practices (GCP), and Current Good Manufacturing Practices (cGMP) have a much longer history in the life sciences industry, they have not always aligned with modern ISO standards. The FDA and other regulatory authorities have been working to harmonize global GxP practices with ISO QMS standards.

QMS Software Solutions for Regulatory Compliance

Depending on your company’s maturity, you may have well established standard operating procedures (SOPs) and quality management policies, as well as many technologies in play supporting your QMS framework. Or you may be a pre-commercial company developing your SOPs and deciding what technology solution to deploy next.
 
Whether you are replacing a current technology or starting from scratch, there are many vendors that support GxP requirements and workflows, but which one is right for your company?
 
USDM helps regulated life sciences companies like yours make the best choices when selecting and integrating technology for GxP processes and applications across your enterprise. We excel at reducing implementation and validation time while optimizing your IT footprint and streamlining your QMS. 
 
While we take a technology agnostic approach to meet your needs, we also know which vendors deliver the best solutions to minimize your compliance burdens, and have a proven software development lifecycle (SDLC), validation documentation, and annual vendor audits to provide the defensible documentation you require.

QMS Consulting for Compliance Frameworks

USDM’s GxP Commercialization QMS Framework is a top-down solution designed to reinforce your quality goals by implementing a governance structure with supporting operational and procedural practices. This helps your organization align its overall quality mission with its quality objectives and organizational roles and responsibilities. 
 
The QMS framework provides clear operational boundaries from a regulatory and quality perspective and complies with FDA cGMP regulations and other global regulatory authorities, including:

  • The European Medicines Agency
  • Health Canada
  • Japan’s Pharmaceuticals and Medical Devices Agency
  • The United Kingdom’s Medicines and Healthcare Products Regulatory Agency 

The QMS framework aligns with industry best practices and standards such as:

  • The International Organization for Standards (ISO)
  • International Council for Harmonization (ICH)
  • International Society for Pharmaceutical Engineering (ISPE)
  • Parenteral Drug Association (PDA)
  • The Pharmaceutical Inspection Co-Operation Scheme (PIC/S)

USDM’s QMS framework can complement or fill gaps within your existing QMS program, or be created from scratch. Read our white paper, Quality Management Systems for Emerging Life Sciences Organizations, for an in-depth view of of how pharmaceutical quality systems when properly implemented can help support an organization’s global strategic quality objectives.

Thought Leaders

Leading experts in every Life Sciences field.

Learn More
Bob Lucchesi
Bob Lucchesi

Vice President of Global Regulatory Compliance, Quality Assurance and Auditing

Jay Crowley
Jay Crowley

Vice President of Medical Device Solutions and Services

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