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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
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
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
Say goodbye to paper! Modernize your processes with connected document, training, and change management
Manufacturing Challenges and Industry Trends Towards Digital Transformation
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
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
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]
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
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
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.
Leveraging AI to Create a Safer Workplace Environment
Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or Azure
Humans: The Real Superheroes of Artificial Intelligence (AI) in Quality Management
ComplianceQuest Medical Devices QMS Success Stories eBook
Complaint Handling Process for MedTech and Life Science Companies
Audit Management
Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest, Rootstock and Salesforce
Unlocking the Value of Complaints
Why You Need to Digitally Transform Your QMS
The Ultimate Guide to ISO/IEC 17025:2017 Compliance
Safety Technology Trends to Watch in 2023 (Infographic)
Data-driven Safety – Strategic Resources for Monitoring of Key Performance Indicators
American Society of Quality Lean Six Sigma Conference
23 Feb, 2025
Phoenix, AZ
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.
Where Your Career Takes Flight: Join our dynamic team and be part of an innovative, collaborative and rewarding workplace culture.
Impact Through Action: How the ComplianceQuest team supports social causes and community engagement
The Pulse of ComplienceQuest: Our newsroom shares stories of innovation, progress, and change
Stronger Together: How our partnerships drive success and innovation
Continuous improvement of quality is a business compulsion for enterprises across the board. Rather than responding to complaints from customers, proactively identifying issues (before it reaches the customer) and rectifying quality gaps earlier in the lifecycle help businesses improve production efficiency, reduce costs, and increase brand reputation.
One of the tools that facilitates a proactive approach to improving quality is the audit of the manufacturing processes in a systematic manner. It helps to uncover problems and implement corrective measures to ensure that the products conform to specifications and meet regulatory requirements. The manufacturing process may be owned by the brand or outsourced to a contract manufacturer. In either case, the quality is the responsibility of the brand and therefore, they are required to ensure the partners meet the quality requirements.
Audits can be conducted by internal teams, or external experts, or can be a mix of both depending on the complexity of the product and the processes. It may take anywhere between a day and weeks depending on the size of operations, the number of units to be audited, etc. It may be a one-time audit or an ongoing process, based on how compliant the manufacturer is. If there are repeat errors and recalls, the manufacturer will have to continuously monitor the process and address the issues. If there are few or no issues reported, the audit may be scheduled periodically, such as every quarter, half-yearly, or yearly.
Audits help manufacturers:
At the time of the audit, the auditors require several aspects of the unit to be audited. These include:
In addition to observing the activities, interviews with the people on the shopfloor can also help get insights that will enhance the findings of the audit.
Auditing is a very detailed process that requires the recording and reporting of the findings for further follow-up. The purpose of the audit will be fulfilled when the subsequent actions are taken to address issues identified during the process and the impact is assessed to see whether it has had the desired effect.
In a paper-based approach, some of the challenges auditors and manufacturers face include:
With an end-to-end audit management system such as ComplianceQuest, companies with smart manufacturing can leverage data to improve the audit workflow end-to-end.
Schedule Audit: Ensure audits happen at the specified periodicity by scheduling at the plant, site, and supplier level.
Prepare for Audits: Auditors can access past reports and documents to review findings, open findings, CAPAs, etc. to assess progress and ensure the corrective actions have been taken and are yielding the desired results.
Record from Anywhere, Anytime: As the audit management software is cloud-based, it can be accessed from anywhere and reports and records created on the go. In case of poor access to Internet connectivity, the software synchronizes the moment connectivity is available. This improves the accuracy of the reports. Images and videos can also be attached as supportive documents. The records can also be categorized based on the audit policies for easy retrieval and sharing.
Pre-built Report Templates: The CQ software provides pre-built report templates and enables the generation of any number of audit reports quickly and easily.
Risk Assessment: Identify risks and enable proactive quality control to mitigate them.
Collaborate and Communicate: The audit reports can be shared with the stakeholders based on relevance from within the system, improving collaboration and communication for faster and more effective action.
Reporting and Analytics: The audit data can be used for creating additional reports and running analytics for deeper insights and data-driven strategic decision-making.
The ComplianceQuest Audit Management software is flexible, scalable, and configurable, enabling the creation of bespoke workflows based on the specific needs of the organization. It is aligned with regulatory standards such as ISO 9001, ISO 13485, FDA 21 CFR Part 11 and allows planning of audits around each of them to improve compliance.
The CQ Audit Management solution is integrated with the EQMS and helps to identify gaps to provide relevant training. This ensures only qualified personnel are assigned based on the standard selected.
It helps manufacturing companies be audit and inspection ready by enabling them to plan, manage changes, learn from past audits, create schedules and assign roles and responsibilities, organize data and documents, and conduct periodic internal audits. The CQ Audit Management Software helps in every step of the way, providing visibility and transparency across the entire process.
To know more, visit: https://www.compliancequest.com/audit-management-software-system/
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