Quality, Compliance & Remediation

We help clients become leaders in customer satisfaction, product quality, and regulatory compliance.

Technological advancements have enabled a fundamentally new way of delivering quality that goes well beyond execution and compliance. Imagine a quality system that:

  • guides companies on when and how their customers’ needs have evolved
  • creates more capacity across the organization by automating analysis, data collection, reporting, and trending so designers can design, engineers can build, and salespeople can sell
  • embeds regulatory compliance within flexible, user-friendly, organically built business workflows

Smart quality builds on the existing objectives of unconditionally delivering on patient safety and regulatory requirements at the lowest possible budget. However, it achieves these objectives in new ways and expands their scope by reframing the role of quality in the modern enterprise. Quality is a value-added partner and coach that helps integrate compliance into regular operations while enabling speed and effectiveness.

Our experience has shown measurable impact from smart quality, including:

  • Up to 2-3 percentage points directly traceable and measurable EBITDA improvement
  • 30+% acceleration in time-to-market for innovation
  • 20-30% increase in manufacturing and supply chain capacity via more agile operations

What we do

Our extensive expertise includes digitization and the automation of quality processes, risk-based process redesign that deploys the newest design-thinking methodology, benchmarking of quality cost and performance, optimization of quality management systems, compliance and remediation services, and fostering a quality culture.
Improve quality processes and systems
Our sharing of best-practice quality processes helps build organizations that are lean, compliant, and effective—typically resulting in 20 through 50 percent improvement in effectiveness and efficiency.
Transition to smart quality
We help clients shape a shared vision across the enterprise through visioning workshops with example use cases, and translate that vision into a roadmap by stages, with clear business case and technology-infrastructure requirements.
Benchmark quality
We deploy proprietary benchmarking tools for quality cost and performance, maturity of quality processes, as well as culture and capabilities to help the organization get a data-based evaluation as a basis for implementing its improvements.

Examples of our work

Smart quality controls
We helped a pharmaceutical company with multiple labs implement an advanced-analytics digital-twin solution and dynamically optimize scheduling in the labs. The scheduling model relied on a continuous feed of production and lab data to automatically generate an optimized allocation of resources—such as equipment and employees. The solution improved productivity by 40 to 50 percent.
Smart quality assurance
We worked with a medtech company to deploy digitization and automation in their complaints-management process to enhance the customer experience, identify and address quality signals faster, and reduce the cost by more than 25 percent. The redesigned intake process has allowed the company to link known issues and their respective safety risks, structure and automate the intake process and customer response for all complaints, and eliminate manual processing for more than 50 percent of complaints.
Process and product mastery
A pharma company used custom advanced analytics to reduce deviations by more than 65 percent. This solution has since helped the company monitor trends, find and eliminate several root causes of recurring deviations that had been impossible to detect with traditional tools, and take preventive action before issues occurred. It also developed a feedback loop with product development teams to improve the robustness of products and processes. The company can now identify the underlying drivers of quality-control test variability and simulate the effect on product properties, enabling product and process mastery.
Smart quality ways of working
A healthcare company worked with us to automate data collection, analysis, and visualization for its quality-management review in order to improve depth of insight and accelerate cross-functional decision making. Automation significantly reduced the manual effort needed to compile and prepare quality dashboards and cut the time needed for report preparation and verification—from six weeks to less than two. An efficient, easily accessible, and user-friendly interface decreased the time required for leadership review by half and enabled high-impact, cross-functional decision making along the entire product value chain.

Featured capabilities

To ensure a deeper understanding of clients’ quality-transformation successes, we invest in developing proprietary tools and methods, including the following:

  • Art of the possible workshop: exploring with experts the overall concept of smart quality and various use cases with videos and live demos to identify potential implications for a company’s quality strategy
  • Smart quality use cases: scoping, business case, roadmap and implementation of use cases in partnership with clients and third parties to ensure effective and efficient technological solution tailored to a company’s needs
  • Design thinking: applying a clean slate, design thinking approach, which includes ideation and quick testing or piloting of improvement ideas to redesign quality processes with an end-user focus
  • POBOS/MDB quality benchmarking: an assessment of product quality and cost, resource efficiency, maturity of operations and processes, and culture to quickly identify near- and longer-term improvements
  • Quality management system maturity diagnostics and structured digital maturity assessments: an assessment of over 50 criteria to identify risks and improvement needs
  • “The first 100 days” playbook: a structured approach to quality- and compliance-crisis remediation for quickly restoring control and minimizing negative impacts on business
  • ACQUA: an assessment of employee capabilities to establish and maintain robust quality-compliance operations
  • Regular quality roundtables: unique forums that bring quality leaders and regulators together to discuss top industry challenges and potential solutions

Related insights

Smart quality: Reimagining the way quality works
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Smart quality: Reimagining the way quality works

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Pharma and medtech companies that adopt a proactive approach to managing the quality function can generate value far beyond improved regulatory compliance.
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Embedding ‘smart quality’ culture and capabilities in the organization
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Pharmaceutical and medical-device companies can get the most value from “smart quality” processes enabled with new technologies by adopting a holistic approach to building culture and capabilities.
Digitization, automation, and online testing: Embracing smart quality control
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Digitization, automation, and online testing: Embracing smart quality control
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The smart quality approach allows pharma companies to digitize, automate, and integrate their quality controls, making them faster, more effective, and more efficient.
Making quality assurance smart
Article
Making quality assurance smart
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Pharmaceutical and medtech companies can dramatically improve quality assurance processes by applying a ‘smart quality’ lens and cutting-edge technologies.
See also our special collection on the future of pharma operations

Featured experts

Álvaro Carpintero
PartnerMadrid
Coleads the firm’s pharmaceutical and medical-products work, and helps companies in a variety of sectors with their operations transformations
Tacy Foster
PartnerCarolinas
Specializes in helping pharmaceutical and medical-product clients transform their quality and manufacturing performance and ensure supply chain resilience
Evgeniya Makarova
PartnerChicago
Serves pharmaceutical, medical-device, and consumer companies as well as regulators on operational improvement, transformation, quality, and compliance issues
Paul Rutten
PartnerAmsterdam
Helps leaders address large-scale quality challenges and achieve stronger results, working across healthcare, pharmaceuticals, and other operations-intensive sectors.