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The only AI-powered Middle Office Platform that unifies PLM, QMS, EHS, and SRM into a single, intelligent solution
Product Lifecycle Management
Enable cross-functional collaboration and accelerate your product lifecycle with a cloud-based platform for innovation
Design Process and Quality System Development Tools in Product Lifecycle
Design Quality
Get full visibility over your product design processes and make collaboration easy to get your products to market faster, compliantly
Design Quality: Connecting Design to Documentation
Complaints Management
Transform customer complaints to valuable sources of insights for continuous improvement through smart automations and integrated regulatory reporting
Challenges with Triage and Investigation in Complaints Management Process
Document and Learning Management
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
Quality Management
Transform quality into an enabler: boost efficiency, increase satisfaction, and trim costs with a fully connected, AI-powered quality management solution
Frost Radar for Quality Management Systems Names ComplianceQuest Leader
Risk Management
Enable risk-based thinking throughout your quality processes with a fully integrated risk management solution
Automation of the Risk Management Lifecycle with AI and Analytics
Supplier Management
Increase supplier performance, reduce costs, and streamline your supply chain with integrated supplier quality and collaboration tools
The Ultimate Guide to Next-Generation Supplier Management [e-Book]
Safety Management
Identify and minimize safety events. Prevent accidents, safeguard workers, and ensure their well-being and health
Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any Enterprise
Environment and Sustainability
Proactively and accurately monitor and measure your company’s impact on the environment to improve performance and reach your environmental and sustainability targets
Environmental & Sustainability Management
Electronic and Automated Approach to Audit Management
Managing the Tools of the Trade
Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
Leveraging CAPA for Continuous Improvement
Ensure your laboratory is compliant with systematic and efficient laboratory investigations
Incident Reporting and Management
Organization, Collaboration and Governance for Efficient Changes
Conduct smart management review meetings with a tower of data to improve your quality and safety systems
Gain 360 degree vision into enterprise wide Safety risks
Enhance Safety and Compliance with Smarter Chemical Management
Ensuring Quality across Departments & Locations
Partner With Suppliers And Vendors To Improve Quality And Safety
Create Loyalty by Addressing Customer Complaints Smartly
Bring Consistency to Permit Practices
Make it easy for your people to manage, track and analyze environmental and sustainability metrics
Bring higher quality products to market quicker with design controls, projects & DHF
Streamline Permit Management and Ensure Compliance
When Learning Propels Organizational Growth
Improve efficiency, productivity, and compliance with a solution designed for today's diverse workforce learning styles
Strategically manage the complete lifecycle of your product
Efficient Waste Management for Compliance & Sustainability
Relevant Information within reach - Always.
Assuring Quality Products and Services
Self-guided Product Tours
Product Demo Videos
Pricing
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.
Salesforce
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
CQ Platform
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
Recent Blogs
Recent Infographics
Recent Case Studies
Featured Case Study
ComplianceQuest Medical Devices QMS Success Stories eBook
Recent Checklists
Featured Checklist
Complaint Handling Process for MedTech and Life Science Companies
Course Offerings
Recent CQ Guides
Featured CQ Guide
Datasheets
Brochures
Demo Center
Podcasts
Podcast
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Videos
Recent Webinars
Webinar
Unlocking the Value of Complaints
Recent Whitepapers
Whitepaper
Why You Need to Digitally Transform Your QMS
Recent Compliance
Compliance
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Infographic
Safety Technology Trends to Watch in 2023 (Infographic)
Recent Toolkits
Featured Toolkit
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
Events and Webinars
Events
Upcoming Webinars
Featured Event
American Society on Quality World Conference on Quality and Improvement
04 May, 2025
Denver, CO
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 product, quality, safety, and supplier as they bring their products from concept to customer success.
Meet the Leadership Team
Careers
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Corporate Citizenship
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
Customers & Testimonials
Newsroom
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Partners
Stronger Together: How our partnerships drive success and innovation
Upcoming Events
Regulatory bodies, including OSHA, insist on Continuous Improvement to ensure safety performance. For businesses to truly focus on safety, they must have the right safety practices in place that help identify gaps and make changes to the overall safety management program to fill the gaps. The same can be applied to quality management also.
Safety audits are conducted in the storage areas, manufacturing units, warehouses, and suppliers. It includes a review of the associated documents and interviews with operations personnel to understand whether the processes are implemented diligently. Root cause analysis is also part of safety audits.
Safety leaders can use the safety audit reports to understand the strengths and weaknesses of the safety initiatives. It helps to evaluate the safety-related policies, procedures, and controls and take necessary measures to reduce risks. Based on the findings, the management and the safety team can also introduce changes to improve the safety management processes.
The FDA's 21 CFR Part 11 regulation focuses on electronic records and electronic signatures. As part of the regulation, it requires organizations to maintain an audit trail. An audit trail is a chronological record of everything in the system, including details of who performed the activity, what modification happened, when it was done, and the reason behind it. An audit trail allows the organization to remain compliant and helps identify and address security breaches and fraudulent activity. Simply put, an audit trail provides an end-to-end view of the system activity.
ISO 19011 defines auditing as a systematic, independent, and documented approach to obtaining objective evidence and determining the extent to which the audit criteria are fulfilled. Audit criteria could be a legal requirement, showing the compliance or non-compliance of the processes and products to the regulatory standards. The requirements encompass work instructions, policies, procedures, contractual obligations, etc.
Broadly, there are two types of audits - internal and external. Internal audits are conducted by, or on behalf of, the organization itself. External audits are either second-party or third-party audits that stakeholders or independent auditing organizations can conduct. Manual audit management processes can make it difficult to have visibility and transparency, making them ineffective and prone to errors.
With automated audit management, businesses can simplify documentation, assign responsibilities, and monitor progress with access to real-time data. This can help improve process efficiency and compliance, initiate CAPA, and provide access to audit trails.
An agile audit allows the internal audit team to meet expectations by accelerating audit cycles, providing timely insights, and cutting process times – all with a more efficient documentation process. In auditing for product and process quality, agile audits can be used to improve the suit process outcome as it is more efficient, offers valuable insights, gives a better understanding of risks, and provides deeper and actionable insights
An agile audit allows audits to be broken down into smaller pieces and reviews to be provided at the end of each short cycle. It can also be leveraged whenever several audits have been scheduled within a time period when there is a need to improve collaboration between stakeholders and when there is a need for more relevant and highly impactful reports with less documentation.
The agile audit requires planning, multiple sprints, a correspondingly high number of reviews and reporting, communication, visibility into the process, tracking, and monitoring. ComplianceQuest uses AI in the Audit Management solution to manage the entire audit workflow on one platform. It facilitates building a flexible, scalable, and configurable audit management workflow based on the organization’s specific needs. AI can also automatically assign days to respond to an audit finding.
Layered Process Audits (LPAs) bring together employees from different departments of the organization instead of only the quality team. LPAs can be used to assess quality at every step, from the design stage to when the finished product is ready to be shipped out. More like a checklist, the LPA enables a risk-based strategy that helps ensure that the process aligns with relevant standards, facilitates continuous Improvement, and identifies high-risk inputs at the beginning of each shift. With LPAs, manufacturers can exercise better and greater control over various processes, take quick corrective/preventive action at all layers, reduce mistakes or nonconformances, improve the overall quality of work, increase revenues, and reduce the total cost of quality.
Layered audits have been commonly used in the automotive and aerospace industries as it focuses on Total Quality Management (TQM) and Total Employee Involvement (TEI).
To conduct LPA, one must answer up to 10 short 'yes or no' questions related to a process, and it takes less than 15 minutes to complete. This synchronizes with the Plan-Do-Check-Act approach and emphasizes the need for a quality-first approach across all processes or 'layers.'
The focus of LPAs is not a comprehensive audit but to narrow down on a few critical, high-risk items, thus accelerating the audit process.
Quality and safety leaders can leverage next-generation EQMS and EHS solutions to conduct effective and useful remote audits. However, an auditor looking to perform remote audits must know these seven areas -
1. Leadership team's commitment and involvement to remote audit seriously and preparation as it would for a regular audit.
2. Understanding the complexity of the processes based on industry and nature of business operations, size of the organization, and the number of locations to be audited.
3. Information on the existing controls to assess the current health and safety success and the gaps that need to be filled
4. Gathering layouts, documents, and processes as part of pre-auditing requirements.
5. Establish communication protocols.
6. Details of the audit process and goals.
7. Employee engagement by gathering their input and ensuring all concerned parties know their role in the process.
To improve quality and safety within the organization, ComplianceQuest offers an Audit Management solution as a part of its EHS platform. The audit management solution is part of both EQMS and EHS solutions. It can integrate seamlessly with document management, training, management review, permit-to-work, incident management, inspection, supplier, environment, and reports and dashboards to manage quality and safety.
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