Compliance Simplified

Quality Management Processes for Life Sciences Organizations

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Quality Management Systems for Emerging Life Sciences Organizations

Discover forward-thinking solutions to simplify your quality management processes, achieve digital quality, and optimize the value of your products and services.

Quality Management processes ensure that a product or service is suitable for its intended purpose, satisfies the customer’s need, and meets applicable regulatory requirements.

Throughout the product development and manufacturing processes, quality must be a high priority. Validation and audits occur after the fact; therefore, quality and continuous improvement loops should be built in from the start. They are your foundation and framework for digital transformation and efficiency.

Strive for Outcomes That Will Transform Your Business

When your organization sets its sights on digital transformation you have great expectations for practical, long-lasting outcomes like:

More automation
Less manual effort
Streamlined operations
Scalable operations without growing pains

These expectations can also support your organization’s efforts to build a digital quality framework. Digital quality safeguards data so that it’s accurate, consistent, and secure. The framework makes real-time data accessible across your organization.

Why is real-time data important? It enables rapid analysis and more precise decision-making. In addition to cross-functional integration, data harmonization, and reporting, your organization is able to maintain perpetual audit readiness.

A digital quality framework is supported by an array of technologies integrated into business operations. For example:

AI and machine learning algorithms analyze large data sets and predict quality issues before they escalate.
Automation, coupled with AI, orchestrates complex manufacturing processes with precision.
Natural language processing (NLP) extracts critical information for predictive analytics and expedites decision-making.

How Does My Company Save Money With Digital Quality?

Aligning data and operations within your digital quality framework helps your organization maintain optimal headcount, face fewer non-conformances and CAPAs, and experience faster turnaround times. Together, this can significantly lower your operating costs.

In the Integrated GxP Compliance webinar, our presenters addressed the types of things that cost your organization money. For example, deviations can easily cost $5,000 to $15,000 and take up to 90 days to resolve. There are opportunities for cost avoidance, too.

Using ProcessX, customers can see direct cost savings from:

Decreased deviations
Reduced CAPAs
Fewer GDP errors
Mitigating re-runs and batch/lot losses
Shorter cycle times
Lower storage costs
Faster audit response times
Lower risk of recall

Weren't We Talking About Quality Management Processes?

Yes! And USDM has the expertise to help you improve these processes, meet your regulatory requirements, and satisfy your customers’ needs. Just as important, we empower your employees to work more efficiently and effectively. We start by identifying and measuring your state of compliance with FDA regulations across all areas of operation in your organization.

QMS Software Solutions for Regulatory Compliance

Depending on your company’s maturity, you may have well-established quality management policies with standard operating procedures (SOPs) and cloud technology supporting your QMS framework. Or you may be a pre-commercial company developing your SOPs and deciding what technology solution to deploy next.

Many vendors support GxP requirements and workflows, but which one is right for your company?

USDM helps regulated life sciences companies 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 business requirements, we also know which vendors deliver the best solutions. We partner with technology vendors that minimize your compliance burdens, have a proven software development lifecycle (SDLC), and provide defensible documentation like annual vendor audits.

Quality Management Systems Consulting Services for Pre-Commercial, Startups

USDM’s GxP QMS Framework is a top-down solution designed to reinforce quality goals by implementing a governance structure that supports operational and procedural practices. This helps pre-commercial companies align their overall quality mission with quality objectives, roles, and responsibilities.

Our team of highly qualified auditors employs the FDA’s Quality Systems Inspection Technique to identify gaps in your system, process, and documentation. We’ll help you fill those gaps or we can build your framework from scratch.

The QMS framework provides clear operational boundaries from a regulatory and quality perspective. It complies with the FDA’s current Good Manufacturing Practice (cGMP) regulations and other global regulatory authorities, including:

Health Canada
The European Medicines Agency
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)

Get an in-depth understanding of how properly implemented pharmaceutical quality systems can help support an organization’s global strategic quality objectives—read our white paper, Quality Management Systems for Emerging Life Sciences Organizations.

Scalable Quality Management System Solutions

Whether you need a managed service, strategic consulting, or staff augmentation, USDM has the right business model for your organization. We can provide one validation engineer, an experienced team, or expert management to facilitate a specific project. Whatever your need, our talent pool and GxP expertise will exceed your expectations to keep projects on schedule and on budget.

Assessments conducted by USDM auditors include recommendations to remediate findings based on your unique circumstances, business priorities, available resources, technical know-how, and regulatory knowledge.

Audit-as-a-Service

USDM helps to streamline your auditing processes by reducing the duration of individual audits, standardizing processes, and developing service level agreements (SLAs) and reporting to ensure success. Trust USDM for support with:

Analyzing vendor audits
Coordinating audit logistics
Establishing an audit tracking system
Assessing product manufacturing from raw materials to final distribution

USDM’s Audit-as-a-Service solution improves your readiness for:

Supplier Audits (CMO, CRO, API, Supply Chain, Distributor)
Pre-Approval Inspection (PAI) Audits
GxP Audits (GCP, GLP, GMP)
Drug Accountability Audits
Device Quality Audits
Internal Audits
Mock Audits
IT Audits

Audit Assurance

In addition to auditing services and documentation, we support your regulatory audits with services like:

Pre-audit assessments of selected customer documentation and processes
Mock audits to help ensure that your audit support team is prepared
Explanations of processes and procedures for documentation requested by auditors
“War room” support during paper-based audits
IT infrastructure assessments to ensure that your technology and processes are compliant.

Remediation Support for Life Sciences Organizations

Each remediation effort is unique. We identify problems and address assessments that need immediate attention. For example, our life sciences experts help to:

Review and update SOPs
Solve data integrity issues
Remedy QMS inadequacies
Provide SOP and GMP training
Avoid manufacturing process failure
Correct medical device design controls
Ensure that systems are adequately tested for intended use
Create and implement an organizational change management strategy

SOP Assessment and Development

USDM offers two types of SOP solutions:

Prepackaged: includes SOP templates for IT Operations and Security, Validation, CSA methodology, or Quality based on standard regulatory requirements and industry best practices.
Custom: includes pre-packaged SOP templates, plus customized SOP development for your specific needs and use cases.

Learn how a large medical device company had 450 QMS SOPs assessed in one month to achieve compliance with the European Union (EU) Medical Device Regulation (MDR). One man-year of technical writing was delivered by nine technical writers provided through the USDM managed staffing business model.

GxP Training and Education

USDM customizes GxP training programs for your business needs using your processes and procedures where applicable. From recurring annual training to a one-off course for a new team, we help your internal teams or external partners stay current with ever-changing regulatory requirements.

You tell us what you need, and we’ll create on-site or remote training programs in subjects like:

GxP
CSV
CSA
SOP
UDI
QMS
Data Integrity
Design Review
Design Control
Risk Management
Regulatory Readiness

Cost is based on the number of classes, attendees, and sessions. We offer hands-on workshops and administer tests to measure training effectiveness. Optional offerings include training videos and certificates of completion.

When you’re ready to empower your employees,
we’re ready to help them work efficiently and effectively.
Contact USDM today to get started.

Let's discuss your quality management processes.

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Cloud Managed Services

USDM’s managed services for life sciences are bundled into subscription models or offered at fixed fees to control your IT spending while maintaining compliance.