Access to the right data at the right time is the key to making Quality and Compliance business decisions. QDS brings together a comprehensive portfolio of Business Intelligence and Data Management services, software, and expertise to deliver risk transparency across an organization’s Quality Management Systems and related business processes.

Effective QMS performance requires companies to continuously analyze processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems in accordance with FDA 21 CFR 820.100 (CAPA).

Unfortunately the information needed for strategic Quality decision-making and Regulatory Compliance is often stored in isolated vertical silos of software applications, departmental spreadsheets, databases, hardcopy production records, and disjointed business platforms with abundant data quality issues. Together this makes it difficult to proactively manage quality systems. As a result, labor intensive data collection of historical performance is typically gathered retrospectively for monthly or quarterly management reviews at a high cost.

The ability to collect, analyze, and proactively monitor internal and external quality & compliance data in a timely manner differentiates our clients from their competitors. QDS offers a comprehensive set of Business Intelligence services to help customers identify actionable key performance indicators for their business and improve risk-based decision-making at all levels of business operations.

QDS Business Intelligence professionals utilize best practices in data management and integration to help organizations improve their competitive edge when it comes to product quality and regulatory compliance.

Competencies, Solutions & Services

To ensure that the right people have the right information at their fingertips and to generate the most value across the organization we utilize the following tools:

  • Microsoft Power BI
  • Microsoft SharePoint Server
  • Microsoft Excel Services
  • Tableau Software
  • SAS Business Intelligence & Analytics
  • Microsoft SQL Server Reporting Services

Our experienced Analytics professionals develop solutions that enable Quality & Compliance stakeholders to make better and faster decisions while being proactive at managing risks.

At QDS we work collaboratively with our customers to evaluate QMS business processes, develop industry best practice KPI’s and metrics, access process maturity, and identify workflow bottlenecks in order to unleash the hidden value in data. We work to optimize and automate processes using Six-Sigma root cause analysis and statistically valid trending techniques. Once processes are optimized, we implement advanced monitoring to maintain stable and repeatable quality results for a distinct competitive advantage.

Our dashboards, metrics, and analytics make it easier than ever for Quality & Compliance professionals to access their data, gain insights, take actions, and proactively manage risks.

QDS offers QMS Analytics and Business Intelligence services in the following areas:

  • Metrics Program Development and Implementation
  • Data Source Verification & Validation
  • Reporting, Visualization, and Dashboards
  • Data Quality (integrity) assessment and remediation
  • Statistical Trending and Predictive Analytics
  • QMS Data Governance Policies and Procedures
  • Quality System Data Integration
  • Market Competitive Intelligence
  • FDA Data Analytics
  • Business Process Engineering
  • Enterprise Compliance Risk Management
  • Quality Data Standardization, Transformation, and Conversion
  • Software Tools implementation
  • Statistical Data Analysis Training>