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Product Lifecycle Management
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Design Process and Quality System Development Tools in Product Lifecycle
Design Quality: Connecting Design to Documentation
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Challenges with Triage and Investigation in Complaints Management Process
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Automation of the Risk Management Lifecycle with AI and Analytics
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The Ultimate Guide to Next-Generation Supplier Management [e-Book]
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Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
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Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
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ComplianceQuest covers the whole spectrum of customers, industries and regions across the world. Whether it is a small, medium or enterprise sized manufacturer, companies choose ComplianceQuest for its end-to-end Product Lifecycle, Quality, Safety and Supplier Management Solutions.
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Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
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Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
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19 Nov, 2025
Silicon Valley, CA
About
About ComplianceQuest
Transform to a fully connected business with a next-generation AI-powered Product Lifecycle, Quality, Safety, and Supplier management platform, built on Salesforce.
Our connected suite of solutions helps businesses of all sizes increase quality, safety and efficiency as they bring their products from concept to customer success.
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A Clinical Quality Management System is a comprehensive framework focusing on patient safety, regulatory compliance, and continuous improvement
With a CQMS, healthcare practitioners can improve overall clinical performance and patient satisfaction
Effective Quality Management System clinical trials management is critical to research success and accelerating clinical studies. This requires data collection and analysis throughout the entire project period while meeting the needs of research and project design, validity and integrity of the data, compliance with SOPs, and the health and protection of the participants. There are various challenges while conducting clinical trials, including patient recruitment, getting the right qualified investigator for the trials, and managing all the data throughout the trial period. Due to the various parameters involved, regulatory bodies have started to enforce a robust Clinical Quality Management System that will help organizations handle trials systematically and diligently.
A clinical trial takes years to conclude. Organizations such as biotechnology, pharmaceutical, and medical device companies, as well as healthcare institutions that conduct these clinical trials, need a proper system through a streamlined process. A Clinical Quality Management System is used exclusively to handle clinical research. Using a Clinical Quality Management System helps reduce data processing time and improve clinical study administration throughout the entire Quality Management System clinical trials lifecycle. These systems help meet regulatory standards, enhance protocol and document management, and accelerate the trial’s ability to meet its goals.
ComplianceQuest offers a robust Clinical Quality Management System (CQMS) that supports end-to-end clinical trial operations with real-time data visibility. This solution becomes a “one-stop shop” for all clinical operations and quality needs. Team members across various departments can collaborate on a single task for the same study and access the updated data in real time. The single platform helps consolidate and update data that all stakeholders can use to make data-backed, real-time decisions.
Circuit Clinical is Raising the Bar on Quality as it Scales and Matures
The quality assurance transformation of one clinical research startup can be largely attributed to the visionary leadership of Mariah Fisher.…
Often clinical trial management and quality management are viewed as separate activities with different teams taking responsibility for each. However,…
A Clinical Quality Management System solution is aimed at reducing decision time and accelerating on-time processing. To that end, there are five key elements that should be considered important in a CQMS. They are:
Reduce dependency on manual methods of pulling trial-critical information to improve patient and participant safety.
Track and manage clinical trial studies from start to finish in compliance with Good Clinical Practices (GCP), FDA 21 CFR Part 50, and 21 CFR Part 11.
Leverage data, analytics, and technology to monitor patient, site, and study performance with a risk-based approach and create a centralized monitoring system to improve site efficiency and productivity, and quality assurance.
A single platform that includes reports and dashboards provides total visibility into the status of each study, country, site, and investigator to create a holistic approach to patient study and trial.
A Patient Portal enables digital patient recruitment and self-registration to eliminate redundant tasks and instill proactiveness among participants.
A research study, such as a clinical trial, is a large and complex process. Doctors and researchers spend years on a single clinical trial to understand the severity of a disease or even develop new drugs to cure it. However, the length of the study comes with its own set of challenges, including limited resources, capital and operational investment for different phases of the trial, and participant selection, among others. Research facilities and life sciences organizations need a streamlined process to properly execute clinical trials. Manual handling of paperwork or legacy methods, such as spreadsheets, comes with its own drawbacks. This is where a robust Clinical Quality Management System comes into play. Having a Clinical Quality Management System will help:
With the availability of consolidated and updated data on a single platform, stakeholders of the clinical trial can track all parties involved and benefit from data-backed, real-time decision-making.
Modern CQMS offers visual dashboards and centralized issue management that all stakeholders can leverage to gain visibility and the power to manage all trial activities in a single system. Integrating data and automating clinical workflows makes it easier to conduct decentralized or virtual trials.
Having a centralized data view enhances safety signal detection, thus easing the site burden.
With comprehensive control, organizations can witness a significant reduction in decision time and accelerated on-time processing.
CQ Clinical QMS fosters best practices for study team members to work together:
Quickly resolve any patient or participant-related queries and accelerate go-to-market time.
Use the solution as a single source of truth to improve the overall health and effectiveness of Quality Management System clinical trials.
Minimize risks such as non-compliance or any other potential disruptions through change traceability across the organization.
Support every stakeholder of the clinical trial, including sponsors, CROs, sites, monitors, investigators, patients, management.
Seamlessly use the system to manage clinical development, operations, supply, regulations, and quality.
Stay compliant with regulations, including ISO 14155, ICH E6 (R2), and other EU regulations, while being audit ready.
Use the solution as a single source of truth to improve the overall health and effectiveness of clinical trials.
We have rolled-out CQ across our company to automate various elements of QMS requirements such as Document Management, Complaints, Non-conformances, Corrective Action (8D and A3), Supplier Management and Audit Management. We have been using the software for more than 2 years. We are glad to see how well the system is being used across the company. We have several thousand users on the system currently and working to scale the usage further. CQ solution has been configured to meet our needs, works elegantly across languages, across time zones, and business verticals. With integration between CQ and SAP to exchange critical data, the process automation provides a lot of productivity.
Lia Budiman,Solution Consultant, Continental Contitech
Powered by Cloudbyz, CQ Clinical Quality Management System is a next-generation, end-to-end clinical trial operations system that improves clinical data access. It is a cloud-based, centralized solution that offers real-time data visibility. CQ Clinical QMS focuses on providing streamlined, customer-centric support across all four phases of clinical trials, including study start-up, patient recruitment, budgeting, pharmacovigilance, and much more. With CQ’s CQMS, companies can handle various challenges, including:
AI in clinical trials is gaining momentum for its ability to dramatically improve the probability of success and reduce timelines. This is because it uses predictive analysis from available historical data. The average timeline for a drug molecule to be released from lab to market is nine years, with a median development cost of $2 billion. The objective of AI implementation is to eliminate unnecessary, repeated clinical evaluations, save costs and time, and thereby ensure successful clinical trials. The AI-based clinical trial transformation process can be divided into three main components:
To know more, read our white paper on ‘End-to-End Management of Clinical Trials: Why Digital Transformation Holds the Key.’
Is Your SMT Line Ready to Deliver Zero-Defect Quality?
Checklist | July 10th, 2025
Essential Checklist for Evaluating AI Capabilities in a Quality Management System (QMS)
Checklist | September 12th, 2024
Manufacturing Quality Control Checklist
Checklist | July 24th, 2023
ISO 9001 Internal Audit Checklist – Part B (Quality Manual, Document Control)
Checklist | May 15th, 2023
ICH E6 (R2) Good Clinical Practice is an international ethical and scientific quality standard that was developed to provide public assurance that the safety, rights, and well-being of trial participants are protected and consistent with the principles throughout the trial.
ISO 14155:2020 is an international quality standard that acts as a guideline to manage clinical investigations of medical devices for human subjects.
(EU) No 536/2014 from European Medicines Agency Clinical Trials Regulation mandates clinical research companies to comply with the standard to assure the public and the regulatory agencies that the subjects are protected while the data generated is robust and reliable.
Gain a real-time view of clinical trial operations.
Accelerate the study start-up process without sacrificing quality.
Maintain inspection readiness and compliance while managing TMF content accurately.
Ensure participant safety, data integrity, regulatory compliance, and on-time safety reporting.
Maintain a state of inspection readiness by driving efficiency and effectiveness into the clinical audit management process.
Ensure all members of the clinical team are trained and certified.
A Quality Management System (QMS) in clinical research is a structured framework that ensures all trial activities are conducted in compliance with regulatory standards, Good Clinical Practice (GCP), and organizational procedures. It helps maintain data integrity, participant safety, and overall study reliability through systematic monitoring, documentation, and continuous improvement.
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Electronics manufacturing is constantly evolving, with fierce competition and tight…
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