Imagine a quality system that automates data collection, analysis, trending, and reporting and builds compliance into business workflows.
Traditional quality compliance tends to focus on health authority requirements, but Smart Quality is proactive and centers on product quality and innovation.
The Smart Quality framework manages quality beyond mere compliance by incorporating risk-based approaches. It uses flexible workflows, speeds up time to market, and improves manufacturing and supply chain responsiveness. It also empowers employees with quality ownership, which helps to reduce compliance risks and improve customer satisfaction.
Smart Quality enables life sciences organizations to leverage artificial intelligence (AI) to drive innovation. It aligns quality management with business objectives, fosters value creation, reduces risks, and improves patient outcomes. In action, Smart Quality:
- Automates data collection, analysis, and reporting: Automation frees up organizational capacity and allows employees to focus on their core responsibilities, which ultimately improves productivity.
- Facilitates decision-making: Companies that integrate AI for data-driven decision-making are better able to anticipate customer needs, satisfy customer requirements, and maintain their own competitive advantage.
- Streamlines compliance: Built-in compliance makes it a natural part of business processes rather than a separate, cumbersome task.
- Enables continuous improvement: Smart Quality significantly reduces deviations and non-conformances and enables you to take a proactive stance on quality.
- Improves operational efficiency: AI solutions like advanced analytics, digital twins for lab scheduling, and automating complaint management processes help to improve productivity and significantly reduce costs.
- Reduces patient risk: Continuous improvement initiatives focused on patient safety rapidly identify and address quality signals and enable faster responses to emerging issues.
A Unified Solution to Achieve Smart Quality
USDM’s ProcessX and Cloud Assurance as a Platform (CAaaP) help your organization shift to Smart Quality.
Using antiquated manual processes, Good Documentation Practice (GDP) errors are inevitable. They may also lead to lengthy deviations. When those deviations reach $15,000 each and corrective and preventive actions (CAPAs) $20,000 each, those costs add up fast.
To make your digital quality process more efficient and to avoid high-risk deviations, rely on ProcessX to automate and optimize the completion, review, and analysis of GxP workflows.
Go from Compliance-Focused to Innovation-Centric
To help your life sciences organization pursue new paths of progress and create value, ProcessX equips citizen developers for innovation with compliance built in.
Go from Paper-Based Processes to Validated Digital GxP Workflows
Realign your approach to GxP process validation with faster and more efficient paperless processes. Validation lifecycle management (VLM) in ProcessX automates and digitizes your validation process and gives your Quality team real-time visibility into all of your GxP system deployments.
Go from Data in Binders to Dashboards with Real-Time Insights
Say goodbye to binders and paper-based workflows that are prone to errors, laborious to research, and difficult to keep in compliance. ProcessX enhances operational visibility with real-time tracking of system statuses and on-demand traceability and reporting.
Go from Stand-Alone Systems to Integrated Systems
Managing parallel IT service management (ITSM) systems for GxP and non-GxP processes often leaves Quality teams to resort to inefficient paper-based methods or unsuitable integrations into Quality Management Systems (QMS). Such setups complicate the change process and obscure visibility across the tech stack, making effective management a significant challenge.
ProcessX ensures that GxP and non-GxP workflows maintain continuous validation with each update. This integration offers IT leaders a compliant and efficient tool to oversee the entire system.
Go from IT-only Development to Citizen Development
Don’t let a long IT queue delay system changes. Citizen development on the ProcessX platform speeds operational efficiency while maintaining compliance—because it’s built in.
Transform Quality Management in Your Life Sciences Organizations
To help your organization adopt Smart Quality and engage your employees to take a proactive role in Quality initiatives, contact us today. We draw on the extensive knowledge of our data, AI, and machine learning experts for key areas like:
- Strategic planning and implementation
- Data governance and integrity
- Process optimization and automation
Strengthen your competitive position in the market. Leverage advanced technologies and modern processes to transform quality management in your life sciences organizations.
