CQ LifeQuest 360: Purpose-Built to Streamline End-To-End Quality Processes in the Life Sciences Sector

As part of our strategic partnership with Salesforce, we unveiled CQ LifeQuest 360™, offering a suite of solutions tailored specifically for the life sciences industry. This purpose-built platform combines the strengths of ComplianceQuest Digital Quality⁺ Platform, Salesforce Life Sciences Cloud and select partners to revolutionize quality management, regulatory compliance, and operational efficiency for organizations in the biopharmaceutical, med tech, consumer health, generics, and animal health sectors.

In this blog, we explore the key challenges in quality management faced by life sciences organizations and how CQ LifeQuest 360™ helps address them with purpose-built features and capabilities.

Quality Management in Life Sciences: Key Challenges

The life sciences industry is bound by stringent regulations and high stakes when it comes to quality management. Organizations face multiple challenges, including:

• Regulatory Complexity: Pharmaceutical, biotech, and med tech companies must comply with various regional and international regulatory bodies like the FDA, EMA, and ISO. Keeping up with changing regulations, ensuring data accuracy, and managing compliance documentation can be overwhelming.
• Managing Risk Across the Supply Chain: Supply chains in the life sciences sector are complex and involve numerous stakeholders. Ensuring that each link in the chain adheres to strict quality standards while managing supplier risks and non-conformance is extremely critical and challenging.
• Data Traceability and Integrity Across the Lifecycle: Ensuring full data traceability across research, clinical trials, product design/development, manufacturing, and commercialization processes is vital for compliance and decision-making. However, managing such vast amounts of data and maintaining its integrity can be resource-intensive without a “connected and unified” solution.
• Accelerating Product Development and Time-to-Market: Innovation is critical in the life sciences sector, but developing new products while adhering to strict regulatory and quality requirements often leads to delays. Streamlining product development while maintaining high-quality standards is a common struggle.
• Operational Efficiency and Process Automation: Manual processes slow down workflows, leading to inefficiencies, delayed approvals, and potential compliance risks. In a highly competitive environment, life sciences companies need to adopt process automation to remain agile and reduce time-to-market.

How CQ LifeQuest 360 Helps Address These Challenges

At the heart of CQ LifeQuest 360™ is its unique value proposition, which sets it apart from other platforms. It provides:

• Unified Platform: A comprehensive suite that addresses every facet of quality management, from R&D to commercialization, through a single platform.
• Core Quality Promise: Covers all QMS processes, ensuring life sciences and med tech companies can meet the highest standards of quality and compliance.
• Data-Driven Decision-Making: By centralizing data and providing comprehensive analytics, it enables companies to make informed, strategic decisions.
• AI-driven Productivity: AI-powered insights and automation streamline operations, enhancing productivity and improving the user experience.
• Full Salesforce Integration: Seamlessly connects with Salesforce’s ecosystem to manage Commercial, Medical, and ESG net zero processes, bringing together patient engagement, clinical/commercial operations, and sustainability on a single, holistic platform.

Key Features and Benefits of LifeQuest 360

• Streamline Product Design and Development with Integrated Quality: LifeQuest 360™ accelerates product development by integrating change management, CAD tools, and engineering workflows, enabling faster design changes and innovation. This helps bring products to market quicker while maintaining top-quality standards, ensuring compliance without compromising speed.
• Centralize Documentation for Improved Accessibility and Compliance: LifeQuest 360™ centralizes all documentation, including SOPs, training, and digital signatures, ensuring teams have quick access to up-to-date information. This streamlines compliance workflows, reduces errors, and boosts efficiency with built-in version control and secure digital signatures.
• Maintain High-Quality Standards with Proactive Monitoring & Resolution: LifeQuest 360™ enables the pursuit of the highest quality standards by providing robust tools for batch record management, change control, non-conformance handling, CAPA, RCA and post-market surveillance. These features enable proactive monitoring and resolution of quality issues, ensuring consistent compliance and safety throughout the product lifecycle.
• Implement Comprehensive Risk Management for Operations and Suppliers: LifeQuest 360™ provides a comprehensive risk management framework that addresses both operational and supplier risks. By identifying potential disruptions early and implementing preventive measures, the platform helps minimize risks, ensuring safety and continuity across the supply chain.
• Strengthen Supplier Relationships and Ensure Quality Across the Supply Chain: LifeQuest 360™ enhances supplier relationships by providing tools for planning, managing, and executing strategic supply chain-related goals. It integrates supplier risk management, quality, supplier audits, and supplier performance analytics, ensuring compliance, collaboration, and continuous improvement across the entire supply chain.
• Enhance Safety Management: LifeQuest 360™ improves job safety by implementing behavioral observations, environmental inspections, and job safety analysis. These features help organizations proactively address potential hazards, ensuring a safer work environment and reducing incidents.

Additionally, Salesforce and other partners bring in the capabilities to automate and streamline:

• End-to-end clinical processes
• Regulatory intelligence, submissions and pharmacovigilance
• Commercial and medical information processes
• Eco compliance, Sustainability and other ESG compliance needs

Customer Success: Leading Diagnostics and Therapeutics Company Chooses CQ

A pioneering life sciences company recently selected ComplianceQuest to support their mission of delivering cutting-edge diagnostic, therapeutic, and virtual care solutions. This company specializes in addressing major health challenges such as Autism Spectrum Disorder (ASD), Parkinson’s disease, mild-Traumatic Brain Injuries (mTBI), and COVID-19.

With a focus on transforming healthcare for families, physicians, and clinicians, their leadership team—comprising experts in engineering, FDA compliance, production, and sales—recognized the need for a comprehensive quality management platform to streamline their operations. By implementing ComplianceQuest, they have enhanced their regulatory compliance, improved product quality, and reduced time-to-market for innovative diagnostic solutions.

The company went with ComplianceQuest’s solution for the following key reasons:

• Our solution made it easy and intuitive to integrate data and documents with all quality management processes
• The process of shifting from the company’s old QMS to CQ was quick and efficient
• The flexibility, configurability and scalability of CQ was an important factor
• It was clear that implementing CQ would free up the time of their quality team to focus on high-impact tasks
• CQ enhanced the process of quality/compliance documentation, change control and overall culture of quality across all departments/teams

To find out more about LifeQuest 360 and join 150+ customers from the Life Sciences sector, request a demo here: www.compliancequest.com/online-demo