Quality Management Processes for Life Sciences Organizations

Establishing and Maintaining Quality Management in Life Sciences

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. USDM has the expertise needed to optimize Quality Management Processes for life sciences.

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.

What is a Quality Management Process?

Quality Management Processes are procedures designed to make sure that a product or service is suitable for the purpose it is intended to fulfill. Quality Management is required to ensure that a product predictably satisfies the customer’s need while also meeting or exceeding regulatory standards of local and international regulatory agencies.

USDM’s team of experts will help you improve these processes, making meeting your regulatory requirements and satisfying your customers more straightforward, and empowering your employees to work more effectively and efficiently. We start by identifying and measuring your state of compliance with FDA regulations across all areas of operation within your plant or facility.

ISO 9001 Certified QMS 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.

Scalable Quality Management Systems Solutions

We offer a range of delivery models to support your QMS needs. From managed services to strategic consulting to staff augmentation—we can craft the right model to meet your needs. USDM can provide one validation engineer, an experienced team, or expert management to facilitate a specific project. Regardless of your need, we have the right talent pool and GxP expertise to exceed your expectations and deliver your project on time and within your budget.

Quality Management Systems Consulting Services for ComplianceQMS

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 how pharmaceutical quality systems when properly implemented can help support an organization’s global strategic quality objectives.