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Middle Office Platform
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
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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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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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The Audit Management module in QMS helps drive efficiency and effectiveness into the audit management process.
Companies conduct different types of audits to maintain checks and balances on different essential aspects of the organization. The important purpose of an audit is to ensure that each business area complies with applicable regulations and works within the confines of corporate policies. Audits are complex as they entail a careful examination of various business processes.
Audit management forms the basis for a sound audit by offering straightforward, measurable steps for achieving specific audit objectives. Documentation of these audit management procedures allows auditors to remain well-informed about ongoing activities with minimal confusion. Audit management procedures are a guideline for auditors, employees, and other stakeholders.
Audit management is a quintessential process to ensure that all audit directives are correctly implemented and executed. It encourages any organization to:
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Audits are an integral component of compliance and regulatory requirements. It is essential for analyzing the success of processes, products, and systems. Audit management is also essential for verifying objective evidence of processes and providing evidence for reducing and eliminating any problem areas.
Quality Audit should highlight examples of good practice rather than simply identifying nonconformance, process issues, and corrective actions to ensure maximum benefit. With this practice in place, other departments can share information and adjust their working practices, delivering continuous improvement as a result.
Keeping track of employees working from an office or remote location
Management can easily monitor tasks while keeping track of their performances
Training employees and providing relevant documents
Checking for accuracy in financial statements
Staying on top of the business’s progress
Reducing the risk of fraud
An effective method for overall evaluation
Identifying problems within the business to effectively address them
CQ’s Audit Management Software helps companies build a scalable, flexible, and configurable audit management workflow, depending on the specific needs. The audit management module offers the following features:
Planning and Scheduling
Plan and schedule audit by site, department, suppliers
Conducting Audits
Take notes, document findings, categorize relevant findings, anywhere, on any device
Audit Report Generation
Generate audit reports using pre-built audit templates
Escalation to CAPA
Prioritize findings and initiate CAPA based on risk
Audit Finding Response
Automatic generation of e-mail messages to the auditee
Mobile Access
Access your CQ Audit Management solution on the go, anywhere, anytime, and on any device.
Preparing for an Audit
Auditors are notified of upcoming audits, and they can prepare by reviewing past audits, open findings, critical findings, CAPAs
Findings Documentation and Categorization
Document findings, attach evidence, and categorize them
Risk Assessment
Capture the risk profile during the audit planning phase and review as per audit findings
Supplier Portal and Interaction
Consolidate all quality data for suppliers to review, rectify, and respond to audit findings
Collaboration
Solicit feedback from the supply chain without giving up ownership of tasks
Reporting and Analytics
Utilize pre-developed best-practices-based reports and create additional reports and dashboards
Customer Success
Enable promptness and perfection in Audit performance
CQ Audit Management Software allows businesses to plan internal and external audits. The software automates the entire audit workflow from audit planning scheduling to documenting findings and initiating CAPAs where required. Quality leaders can set up calendar views to alert all stakeholders about scheduled audits and prepare accordingly. It also empowers them to choose between complex, stringent, or streamlined audits flexibly.
Ensures effectiveness and continuous improvement of your QMS
Automate audit workflows with CQ Audit Management Software. The software enables business and quality leaders to identify gaps, predict quality performance in the future, capture failure trends, and take corrective and preventive action for continuous improvement.
Stay Compliant
With CQ Audit Management Software, businesses can plan audits for different regulatory standards such as ISO 13485, ISO 9001, FDA 21 CFR Part 11 to remain compliant.
Always remain Audit and Inspection ready
The first step in risk management is to know the gaps. The CQ Audit Management Software helps in having a proactive risk management strategy, providing visibility and transparency across the entire process. The software allows businesses to plan, manage changes, learn from past audits, assign roles and responsibilities, create schedules, organize data, and conduct periodic internal audits.
Avoid Fines and Penalties
Periodic and well-planned and executed audits can help mitigate non-compliance risks by identifying the gaps in a timely manner and reducing the impact on the business. The CQ Audit Management Software manages the entire audit cycle to ensure greater compliance and growth and avoid non-compliance penalties.
The audit is carried out either by trained members of an organization’s staff (internal quality audit) or by auditors from outside the organization (external quality audit). The process of quality audits is divided into four phases within the system as follows:
The first step in the quality audit process is audit initiation. This involves a preliminary discussion between three parties: the client, the auditee, and the auditing organization. The discussion includes:
Audit planning includes several processes and activities by implying actions and reactions from the involved parties, including scheduling the audit, the number of resources needed, gathering audit, reporting the results, determining the sampling procedures, and following up on corrective and preventive actions.
After audit initiation and planning, the auditor starts to perform various activities such as evaluation of process and system controls, employee interviews, on-site audit management, and regular communication with other relevant parties within the organization. Audit execution is often called ‘fieldwork’. It concludes with the final discussion between the auditor and the auditee.
The audit report includes the observation results, inspection or test results obtained, providing data on management, conformances and non-conformances found. It also includes recommended corrective actions that need to be taken.
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.
CQ configuration team and support have worked hard to ensure that our needs continue to be met. They consistently go above and beyond. We cannot be more pleased with our use of CQ QMS capabilities and would definitely recommend to anyone who is looking for a modern cloud based EQMS solution especially if you want a scalable EQMS solution.
Lia Budiman,Solution Consultant
Audits are an integral component of compliance and regulatory requirements. They are essential for analyzing the success of processes, products, and systems. They are also a vital tool for verifying objective evidence of processes and providing evidence for reducing and eliminating any problem areas.
Audit management highlights areas of process issues and nonconformance that need corrective actions. This can help other departments to share information and adjust their working practices, delivering continuous improvement as a result. A robust audit management system supports the entire organization. ComplianceQuest Audit Management module helps:
Recommended Articles
An effective management audit helps organizations assess their overall performance, identify areas for improvement, and ensure compliance with regulations and industry best practices. Here's a step-by-step guide on how to conduct a thorough and effective management audit:
Management audits come in various forms, each tailored to specific objectives and areas of focus. Here are different types of management audits and the benefits they offer:
MDSAP Remote Audit
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A Three-in-One MDSAP Audit Preparation Tool kit (Part – 1)
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A Three-in-One MDSAP Audit Preparation Tool kit (Part – 2)
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Internal Audit Tool Kit for Medical Device and IVD Manufacturer (Part – 1)
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An audit is considered an effective management tool to detect the problems and defects in the quality management system and helps improve and resolve them based on broad findings and recommendations. The principles of an audit are as follows:
Objectivity
Ethical standards
Accurate presentation
Independence
Professional support
Proficiency
Assessment based on evidence
Confidence
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