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Capa Management

This document provides an overview of CAPA (Corrective and Preventive Action) management software. The software enables users to (1) identify and initiate CAPA processes, (2) conduct investigations and root cause analyses, (3) define action plans, and (4) ensure effectiveness through verification and closure. Key features include risk assessment, review and approval workflows, linking to other quality processes, and reporting and analytics. The goal is to help users drive continuous improvement by addressing systemic issues and mitigating risks.

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0% found this document useful (0 votes)
54 views

Capa Management

This document provides an overview of CAPA (Corrective and Preventive Action) management software. The software enables users to (1) identify and initiate CAPA processes, (2) conduct investigations and root cause analyses, (3) define action plans, and (4) ensure effectiveness through verification and closure. Key features include risk assessment, review and approval workflows, linking to other quality processes, and reporting and analytics. The goal is to help users drive continuous improvement by addressing systemic issues and mitigating risks.

Uploaded by

vini157
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Datasheet

CAPA
MANAGEMENT
Drive continuous improvement
(CI) of operations with a
comprehensive yet easy-to-
use system designed to
effectively manage your
corrective and preventive
action processes
ENABLE YOUR WORKFORCE TO DETECT AND
ADDRESS SYSTEMIC ISSUES AND MITIGATE
RISKSWITH A WORLD-CLASS CAPA
MANAGEMENT SOLUTION
With CQ CAPA Management, you can identify and
initiate a corrective and/or preventive action
process, detect trends, conduct or link to an
existing investigation or root cause analysis (RCA),
define action plans, and ensure effectiveness with
structured verification and closure workflows
For any enterprise, a robust CAPA process is crucial to address systemic issues and drive
continuous improvement of your business operations. CQ’s CAPA management solution
uses predictive analytics and intelligence to identify the right issues to solve. Our key
focus is on helping you implement effective preventive action plans to mitigate risks. Our
solution supports various methodologies like 8D, 5W-2H, and World Class Manufacturing
(WCM).

2
Management Quality

Get visibility across issues in real-time to Improve process control to reduce quality gaps,
quickly identify systemic issues, reduce cost, lead time, increase production yield and
and prevent recurrences prevent non conforming products and the
associated custmer satisfaction from reaching
the marketplace

Manufacturing Engineering

Enable teams to quickly capture, triage, find Quickly access necessary nonconformance
the root cause, and take any remedial steps Support Your data to perform investigation and risk
to effectively prevent waste, rework, Entire Organization assessment to eliminate the root cause(s)
and delays

Operations Suppliers

Easy retrieval of information to reduce review Gain visibility, improve collaboration and
cycle time and for data-driven decisions to minimize lag times for supplier corrective
authorize disposition of nonconforming actions
material

Key CAPA Management Features


Effectiveness Verification
& Closure

Implementation Link to other EQMS Processes

Communication/
Reviews & Approvals Collaboration

Define Action Plans ERP/CRM Integration

Investigation & 5 WHY


Root Cause Analysis Mobile Access

Assess Risk Reporting & Analytics

Identify and Initiate Social Like & Follow

3
IDENTIFY AND INITIATE ASSESS RISK
Analyze all possible issues that need Each documented event may be
a CAPA, irrespective of whether the systematically evaluated for risk to
source of the issue is a product, determine the type and priority of CAPA.
process, or even a continuous Risk assessment can be performed
improvement (CI) initiative. Document using established risk standards and
different types of CAPA events using can be followed both locally and
user-friendly web forms. globally.

INVESTIGATION & 5 WHY DEFINE ACTION PLANS


ROOT CAUSE ANALYSIS
Take advantage of configurable BI &
5 WHY Root Cause Analysis Dashboard analytics that measure KPI’s and
allows global teams to collaborate wile improvements specific to your needs
they document numerous root causes,
attach evidence and capture decisions
as needed for the investigation.

REVIEWS & APPROVALS IMPLEMENTATION


Route the CAPA record for reviews to Enables plan assignees to implement
relevant people and solicit feedback the approved corrective and preventive
and necessary approvals. Approvers action plans. Additional plans can be
can either be predefined based on recorded as deemed necessary to
the type of CAPA or can be defined effectively address the root cause.
dynamically.

EFFECTIVENESS VERIFICATION LINK TO OTHER EQMS PROCESSES


& CLOSURE
Integrated with Audit Management,
Track the effectiveness of CAPA actions. Change, Complaints, Nonconformance,
After the preventive actions have been and other key EQMS Processes.
successful and the issue hasn’t
recurred, close the CAPA.

COMMUNICATION/ COLLABORATION ERP/CRM INTEGRATION


Collaborate with team members, CQ EQMS integrates with ERP and CRM,
suppliers, and other stakeholders to to ensure quality data is tracked across
ensure the CAPA steps have been the product lifecycle, end-to-end.
implemented as needed.

MOBILE ACCESS REPORTING & ANALYTICS


Access your EQMS solution on the go — Utilize pre-developed best
anywhere, anytime, and on any device. practices-based reports. Create any
Complete access to the solution number of additional reports and
including reports, approvals, record dashboards to suit your requirements,
views, reviews, alerts, etc. then easily extract the data you need to
make quick decisions.

SOCIAL LIKE AND FOLLOW


Like and follow relevant records in the
system. Choose to be notified via email,
dashboard, and/or mobile to stay
abreast of developments.

4
Next-gen AI-Powered Quality and Safety management platform
EQMS EHS

MARKET QUALITY SUPPLIER RISK WORKFORCE HEALTH AND ENVIRONMENT &


INTEGRATIONS SURVEILLANCE MANAGEMENT MANAGEMENT MANAGEMENT DIGITALIZATION SAFETY SUSTAINABILITY
CONNECTIVITY

CRM Complaint
Management
Audit Document
Exchange
Risk Audit Document
Management
Contractor
Safety
Aspects &
Impacts
EBR Regulatory
CAPA
Deviations
Risk Register
Change Incident Mgmt Environmental
Assessment Change Process Management -Injuries, Audit
ERP Control Material Inspection Security
Regulatory Inspections SOP Vehicle, Notice of
HRMS Reporting Deviation Investigation Enforcement Property Violation
On/Off-
LIMS MDR eGateway Equipment Boarding Training JSA/JHA Permit
Management
MES Field Service Investigation PPAP Learning Portal Permit to Work
Connector Regulatory
MOM Non- SCAR LearnAbout Regulatory Library
conformance GMP/Safety Forms
PLM Supplier Spills and
OOS/OOT Central Safety Audit Releases
RIMS
Product Supplier Safety Sustainability
Others Inspection Rating/Score Observations Reporting
Card
Near Miss
Vendor Audit

MANAGEMENT REVIEW

Artificial
Analytics Dashboards, Reports Collaboration Community Communication Mobile Validation Intelligence

PLATFORM POWERED BY

Fastest Growing 100% Native Salesforce Based EQMS and


EHS Solutions – Mobile, Secure, Reliable, Scalable, Configurable

About ComplianceQuest
Transform to a fully connected business with a next-generation AI-Powered 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. Our intelligent data-driven platform comes with best-in-class
integrated processes to mitigate risks, protecting your employees, suppliers and brand reputation, and to increase innovation,
compliance, profit and customer loyalty. ComplianceQuest is pre-validated and easy to implement, use, and maintain,
allowing for streamlined communication and collaboration across the product value chain.

For more information, or to request a demo with a ComplianceQuest expert, contact ComplianceQuest today:

• Visit www.compliancequest.com
• Email us at [email protected]
• Call us at 408-458-8343

© 2022 ComplianceQuest. All rights reserved. Confidential and Proprietary. Publishing of this content is not allowed without express permission from ComplianceQuest.
The information contained in this document is intended for general information purposes only and is subject to change without notice. Any third-party brand names and/or
trademarks referenced are trademarks of their respective owners.

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