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Text Content

 * Solutions
    * 
      Product Lifecycle
    * 
      Design Quality
    * 
      Complaints Management
    * 
      Document and Knowledge Management
    * 
      Quality Management
    * 
      Risk Management
    * 
      Supplier Management
    * 
      Safety Management
    * 
      Environment and Sustainability
   
   PRODUCT LIFECYCLE
   
   Enable cross-functional collaboration and accelerate your product lifecycle
   with a cloud-based platform for innovation
   
   Explore More
   
   Design Process and Quality System Development Tools in Product Lifecycle
   
   Read Whitepaper
   
   DESIGN QUALITY
   
   Get full visibility over your product development processes and make
   collaboration easy to get your products to market faster, compliantly
   
   Explore More
   
   Design Quality: Connecting Design to Documentation
   
   Read Whitepaper
   
   COMPLAINTS MANAGEMENT
   
   Transform customer complaints to valuable sources of insights for continuous
   improvement through smart automations and integrated regulatory reporting
   
   Explore More
   
   Challenges with Triage and Investigation in Complaints Management Process
   
   Read Whitepaper
   
   DOCUMENT AND KNOWLEDGE MANAGEMENT
   
   Say goodbye to paper! Modernize your processes with connected document,
   training, and change management
   
   Explore More
   
   Manufacturing Challenges and Industry Trends Towards Digital Transformation
   
   Read Whitepaper
   
   QUALITY MANAGEMENT
   
   Transform quality into an enabler: boost efficiency, increase satisfaction,
   and trim costs with a fully connected, AI-powered quality management solution
   
   Explore More
   
   Frost Radar for Quality Management Systems Names ComplianceQuest Leader
   
   Read Whitepaper
   
   RISK MANAGEMENT
   
   Enable risk-based thinking throughout your quality processes with a fully
   integrated risk management solution
   
   Explore More
   
   Automation of the Risk Management Lifecycle with AI and Analytics
   
   Read Whitepaper
   
   SUPPLIER MANAGEMENT
   
   Increase supplier performance, reduce costs, and streamline your supply chain
   with integrated supplier quality and collaboration tools
   
   Explore More
   
   The Ultimate Guide to Next-Generation Supplier Management [e-Book]
   
   Read Whitepaper
   
   SAFETY MANAGEMENT
   
   Identify and minimize safety events. Prevent accidents, safeguard workers,
   and ensure their well-being and health
   
   Explore More
   
   Safety Essentials: Key ‘Must-have’ Components for Safety Management at Any
   Enterprise
   
   Read Whitepaper
   
   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
   
   Explore More
   
   Environmental & Sustainability Management
   
   Read Datasheet
   
 * Products
    * Audit
      
      Electronic and Automated approach to Audit Management
   
    * Equipment
      
      Managing the Tools of the Trade
   
    * Risk Management
      
      Manage Operational Risk Tracking, Evaluation, Mitigation and monitoring
   
    * CAPA
      
      Leveraging CAPA for Continuing Improvement
   
    * Lab OOS
      
      Ensure your laboratory is compliant with systematic and efficient
      laboratory investigations
   
    * Safety Incident Management
      
      Incident Reporting and Management
   
    * Change
      
      Organization, Collaboration and Governance for Efficient Changes
   
    * Management Review
      
      Conduct smart management review meetings with a tower of data to improve
      your quality and safety systems
   
    * Safety Inspection
      
      Gain 360 degree vision into enterprise wide Safety risks
   
    * Complaints
      
      Create Loyalty by Addressing Customer Complaints Smartly
   
    * Nonconformance
      
      Ensuring Quality across Departments & Locations
   
    * Supplier/Vendor Management
      
      Partner With Suppliers And Vendors To Improve Quality And Safety
   
    * Design Controls
      
      Bring higher quality products to market quicker with design controls,
      projects & DHF
   
    * Permit to Work
      
      Bring Consistency to Permit Practices
   
    * Sustainability
      
      Make it easy for your people to manage, track and analyze environmental
      and sustainability matrics
   
    * Document
      
      Relevant Information within reach - Always.
   
    * Product Inspection
      
      Assuring Quality Products and Services
   
    * Training/LMS
      
      When Learning Propels Organizational Growth

   
   
 * Industries
   
   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, and Safety Management Solutions.
   
    * All
    * Quality First
    * Compliance First
    * Safety First
   
    * Aerospace and Defense
    * Automotive
    * Blood, Plasma & Tissue
    * Consumer Package Goods
    * Cell & Gene Therapy
    * Construction
    * Cannabis
    * Digital Healthcare
    * Energy & Utilities
    * Food and Beverages
    * Manufacturing
    * Medical Devices
    * Oil & Gas
    * Pharmaceutical and Biotech
    * Public Sector/Labs
    * Transportation
   
    * Aerospace and Defense
    * Automotive
    * Consumer Package Goods
    * Food and Beverages
    * Manufacturing
   
    * Blood, Plasma & Tissue
    * Cell & Gene Therapy
    * Cannabis
    * Digital Healthcare
    * Medical Devices
    * Pharmaceutical and Biotech
    * Public Sector/Labs
   
    * Construction
    * Energy & Utilities
    * Oil & Gas
    * Transportation

   
   
 * Platform
    * Salesforce
    * CQ Platform
    * FDA Validation
   
      SALESFORCE
   
    * 
      Salesforce Platform
    * QHSE for Salesforce
    * 
      Salesforce Trust
   
   Leveraging AI to Create a Safer Workplace Environment
   
   Explore
    * Why Salesforce?
    * Learn Why Salesforce QHSE
    * Manufacturing
    * Health Cloud
    * Supply Chain
    * Service Cloud
   
   Why an EHS Solution Built on Salesforce Works Better Than One Built on AWS or
   Azure
   
   Explore
   
      CQ PLATFORM
   
    * 
      CQ.AI
    * 
      CQ Certifications
    * Technology
   
   Power Your Enterprise with CQ.AI for Clinical, Quality, Health and Safety
   
   Explore
   
    * Audit Trail / E-Signature
    * Data privacy and Security
    * Integration
    * User Experience
    * Real-time Data Analytics

   
 * Resources
    * 
      Blogs
    * 
      Case Studies
    * 
      Checklists & Templates
      
    * 
      Datasheets
    * 
      Demo Center
    * 
      Infographics
    * 
      Podcast
    * 
      Videos
    * 
      Toolkits
    * 
      Webinars
    * 
      Whitepapers
   
   RECENT BLOGS
   
    * 5 Reasons Why Safety Culture Impacts Business KPIs
    * Nonconformance (NC) vs. Out of Specifcation (OOS) in the Pharma Sector
    * Key Considerations For Choosing The Right Audit Management System Software
    * Culture of Better Quality: The Role of Robust Internal Audits
   
   Read More Blogs
   
   FEATURED BLOG
   
   The 8D Way to Manage Your Corrective/Preventive Action Processes
   
   Read Blog
   
   RECENT CASE STUDIES
   
    * Medical Device Manufacturer Invests in new Backbone of Quality Management—
      ComplianceQuest’s AI-powered EQMS
    * 2 Directors of Quality Directing the Way for Operational Excellence
    * Winning Story of Two Businesses Using the CQ Training and Document
      Management Solution to Improve Their Quality Management Process
    * Complaints Resolution Transformed: 3 Companies Implement Next-Gen
      Complaints Solution
   
   Read More Case Studies
   
   FEATURED CASE STUDY
   
   ComplianceQuest Medical Devices QMS Success Stories E-Book
   
   Read Case Study
   
   RECENT CHECKLISTS
   
    * Manufacturing Quality Control Checklist
    * Comprehensive Checklist for Manufacturing Workplace Safety Walks
    * Comprehensive Manufacturing Workplace Inspection Checklist
    * 6 Indispensable PTW Checklists - Mitigating Hazards with Proactive
      Measures
   
   Explore
   
   FEATURED CHECKLIST
   
   Complaint Handling Process for MedTech and Life Science Companies
   
   Download Checklist
   
   RECENT CQ GUIDES
   
    * How to use nonconformance reports to improve quality assurance
    * How to implement Salesforce CRM to improve EHS practices in your
      organization
    * How can medical device manufacturers prepare for ISO 13485 certification
    * How to use cloud-based change management software in your organization
   
   Explore
   
   FEATURED CQ GUIDE
   
   
   
   Read CQ Guide
   
   DATASHEETS
   
    * Enterprise Quality Management System Application Solution
    * Environment, Health, Safety and Sustainability Application Solution
    * Power Your Enterprise with CQ.AI for Clinical, Quality, Health and Safety
    * Safety Essentials
   
   Read More Datasheets
   
   FEATURED DATASHEET
   
   Audit Management Software
   
   Read Datasheet
   
   PRODUCT DEMO CENTER
   
    * Audit Management: Digitally Transform Your Audit Management Process
    * CAPA Management: Managing Quality Using Corrective and Preventive Actions
    * Change Management: Managing Change Throughout Your Enterprise
    * Complaints Management: Seamless Management of Complaints
   
   Explore
   
   FEATURED PRODUCT DEMO
   
   Risk Management: Managing Risk in Today’s Complex World
   
   Watch Product Demo
   
   PODCASTS
   
    * Transforming Crisis into Opportunity: MedTech Manufacturers' Triumphs
      During the Pandemic
    * The Compliance Connection - Policy, People, and Safety
    * Advantages of an Integrated PLM and QMS Solution
    * Unlocking BBS Principles and Safety Management Best Practices
   
   Explore
   
   PODCAST
   
   Aphria (now Tilray) CIO talks about their implementation of ComplianceQuest,
   Rootstock and Salesforce
   
   Listen to Podcast
   
   VIDEOS
   
    * EQMS for the Cannabis Industry
    * Document, Training and Change Management Solutions Demo
    * CQ’s Software Validation Approach for Life Sciences Companies
    * Why IT Managers love ComplianceQuest
   
   Explore
   
   VIDEO
   
   Training Management
   
   Watch Video
   
   RECENT WEBINARS
   
    * Streamlining EHS Practices: Leveraging the Salesforce CRM for Efficient
      Environmental, Health and Safety Management
    * Understanding the FDA’s Strategic Priorities for CDRH for 2023 and Beyond
    * Streamlining New Product Introduction Across the Value Chain
    * Mastering EHS Compliance: Key Strategies for Demonstrating Regulatory
      Governance and Control
   
   Explore
   
   WEBINAR
   
   Unlocking the Value of Complaints
   
   Watch Webinar
   
   RECENT WHITEPAPERS
   
    * Enhancing Safety Outcomes in Your Organization: The Advantages of Shifting
      from Reactive to Proactive Behavior-based Safety (BBS)
    * The Human Factor in Nonconformance Management: Why Culture, Training, and
      Communication Matter in Managing Nonconformances
    * The Role of Change Management in Digital Transformation
    * From Manual Hassles to Automated Bliss: Transforming Injury and Illness
      Reporting with Next-generation OSHA Reporting Software
   
   Explore
   
   WHITEPAPER
   
   Why You Need to Digitally Transform Your QMS
   
   Read Whitepaper
   
   RECENT INFOGRAPHICS
   
    * Nonconformance (NC) vs. Out of Specifcation (OOS) in the Pharma Sector
    * Serious Injuries and Fatalities (SIFs) at the Workplace
    * 5 Key Questions in the Minds of EHS Leaders: Insights from a Verdantix
      Survey (infographic)
    * Navigating EHS Performance (Infographic)
   
   Explore
   
   INFOGRAPHICS
   
   Safety Technology Trends to Watch in 2023 (Infographic)
   
   Explore
   
   RECENT TOOLKITS
   
    * Effortless ISO 45001 Implementation - A Bundle of 7 Essential Resources
      for Workplace Safety
    * Your One Stop for Safety Inspections with 6 Powerful Resources for Safer
      Workplace
    * Data-driven Safety – Strategic Resources for Monitoring of Key Performance
      Indicators
    * 7 Essential Resources for Productive Management Review Meeting
   
   Explore
   
   FEATURED TOOLKIT
   
   Data-driven Safety – Strategic Resources for Monitoring of Key Performance
   Indicators
   
   Explore
   
 * Company
    * About
    * 
      Careers
    * 
      Corporate Citizenship
    * Customers & Testimonials
    * 
      Newsroom
    * 
      Partners
    * Upcoming Events
      
   
   ABOUT
   
   
   
    * About CQ
    * Leadership Team
      
    * Awards & Mentions
   
   
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   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.
   
   Explore More
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   MEET THE LEADERSHIP TEAM
   
    * 
    * 
    * 
    * 
   
   CORPORATE CITIZENSHIP
   
   Impact Through Action: How the ComplianceQuest team supports social causes
   and community engagement
   
   Explore More
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   MEET THE LEADERSHIP TEAM
   
    * 
    * 
    * 
    * 
   
   CUSTOMERS & TESTIMONIALS
   
   
   
    * Customers
    * Testimonials
    * CQ Heroes
   
   
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   MEET THE LEADERSHIP TEAM
   
    * 
    * 
    * 
    * 
   
   NEWSROOM
   
   The Pulse of ComplienceQuest: Our newsroom shares stories of innovation,
   progress, and change
   
   Explore More
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   MEET THE LEADERSHIP TEAM
   
    * 
    * 
    * 
    * 
   
   PARTNERS
   
   Stronger Together: How our partnerships drive success and innovation
   
   Explore More
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   MEET THE LEADERSHIP TEAM
   
    * 
    * 
    * 
    * 
   
   UPCOMING EVENTS
   
   
   
      
    * Webinars
   
   
   
   ABOUT COMPLIANCEQUEST
   
   Transform to a fully connected business with a next-generation AI-powered
   Product Lifecycle, Quality and Safety 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.
   
   MEET THE LEADERSHIP TEAM
   
    * 
    * 
    * 
    * 

   

Support | Contact Us
Request Demo

   
 * Solutions
    * Product Lifecycle
    * Design Quality
    * Complaints Management
    * Document and Knowledge Management
    * Quality Management
    * Risk Management
    * Supplier Management
    * Safety Management
    * Environment and Sustainability

   
   
 * Products
    * Audit
    * CAPA
    * Change
    * Complaints
    * Design Controls
    * Document
    * Equipment
    * Lab OOS
    * Management Review
    * Nonconformance
      
    * Permit to Work
    * Product Inspection
    * Risk Management
    * Safety Incident Management
    * Safety Inspection
    * Supplier/Vendor Management
    * Sustainability
    * Training/LMS

   
   
 * Industries
    * Aerospace and Defense
    * Automotive
      
    * Blood, Plasma & Tissue
    * Cannabis
    * Cell & Gene Therapy
      
    * Construction
    * Consumer Package Goods
      
    * Digital Healthcare
    * Food and Beverages
    * Manufacturing
    * Medical Devices
    * Oil & Gas
    * Pharmaceutical and Biotech
    * Public Sector/Labs
    * Transportation
      
    * Utilities

   
   
 * Platform
    * Salesforce Platform
      
    * QHSE for Salesforce
       * Why Salesforce?
       * Learn Why Salesforce QHSE
       * Manufacturing
       * Health Cloud
       * Supply Chain
       * Service Cloud
   
      
    * Salesforce Trust
    * CQ.AI
    * CQ Certifications
      
    * Technology
       * Audit Trail / E-Signature
       * Data privacy and Security
       * Integration
       * User Experience
       * Real-time Data Analytics
   
      
    * FDA Validation

   
   
 * Resources
    * Blogs
    * Case Studies
    * Checklists & Templates
      
    * Datasheets
    * Demo Center
    * Infographics
    * Podcast
    * Toolkits
    * Videos
    * Webinars
    * Whitepapers

   
   
 * Company
    * About CQ
    * Leadership Team
      
    * Awards & Mentions
    * Careers
    * Corporate Citizenship
    * Customers
    * Testimonials
    * CQ Heroes
    * Newsroom
    * Partners
      
      
      
    * Upcoming Webinars

 * Support
 * Contact Us
   


A FOOL-PROOF PLAN FOR BUILDING AN EFFECTIVE CAPA PROCESS

Whitepaper | March, 2023
 * 
 * 
 * 
 * 

Download Whitepaper

The CAPA plan must be fool-proof to ensure compliance while correcting a problem
and prevent its future recurrence.

For the effective implementation of CAPAs, quality leaders need access to data.
This will help them identify the nature and type of variation, understand the
actions needed to contain the impact, perform root cause analysis, implement
CAPA, measure its progress, and conduct management reviews. The data will also
act as input for identifying skill gaps and the kind of training needed. In a
manual or legacy-based system, enterprise-wide data may not be easily accessible
due to siloed systems. As a result, access to data is limited, leading to
ineffective CAPA implementation and a possible violation of regulatory
standards.

A modern, cloud-based solution will help by integrating the different data
sources your company relies on and provides a unified view of data to reduce the
risk of having an ineffective CAPA process. ComplianceQuest offers a
next-generation enterprise-wide Quality Management System that helps businesses
integrate root cause analysis and CAPA with other functional areas and
quality-related processes such as inspection, audit, risk assessment, management
review, training, and documentation.

This empowers the CAPA team with access to data needed to identify risks,
understand the impact, determine the problems that need CAPA, perform a root
cause analysis, implement the necessary corrective actions, and communicate with
the relevant stakeholders for resolution, review, and continuous improvement. It
also automates the documentation workflow and enables the delivery of relevant
training from within the system. This also creates an audit trail and improves
compliance.

In this whitepaper, we will talk about:

 * What does FDA expect from your CAPA
 * Pointers for creating a compliant and robust CAPA plan
 * Automating CAPA planning, implementation and review
 * And more



Download Whitepaper


RELATED WHITEPAPERS

 * Whitepaper | June 9th, 2023
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   If you lack a formalized CAPA plan, how will you effectively identify the
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 * Whitepaper | December 1st, 2022
   How Does FDA Train its Inspectors to Investigate Your CAPA Processes?
   
   One of the most important quality system elements is the corrective and
   preventive action subsystem.…

 * Whitepaper | October 26th, 2022
   Challenges Related to Escalating Complaints to CAPA
   
   Complaint Handling and CAPA management are two cornerstone processes of any
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Regulations
 * 21 CFR Part 11 / Annex 11
   
 * FDA Software Validation
   
 * ISO 9001 - General Quality
 * AS 9100 - Aerospace
 * IATF 16949 - Automotive
 * ISO 13485 - MedTech
   
 * ISO 14001 - Environmental
 * ISO 45001 - Safety
   

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