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CAPA Management

Leveraging CAPA for Continuous Improvement

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What is ComplianceQuest’s CAPA Management Software?

ComplianceQuest’s CAPA Management Solution is a comprehensive yet easy-to-use system designed to effectively manage the corrective action/preventive action processes while integrating with other quality processes critical to regulatory compliance, such as audits, nonconformance, change control and customer complaints. The CQ CAPA solution’s step by step out of the box workflow is made of foundation blocks along with a built-in workflow indicator. Companies can use workflow as is or may configure to suit their needs.

CAPA Management Software Features

Identify
And Initiate

The CQ CAPA Management Software system enables organizations to systematically analyze all possible candidates for it to be issued against, whether the source is product, process or even continuous improvement related initiative. You can document different types of CAPA events using user-friendly web forms and also connect associated events from one or multiple location or divisions and even generated from your supply chain triggered event.

Assess
Risk

Each documented event may be systematically evaluated for risk to determine the type and priority of CAPA. Risk assessment can be performed using established risk standards and can be followed globally. Consistent risk assessment eliminates and dramatically reduces overall risk. If the outcome of the risk assessment deems a CAPA is not necessary, the CAPA Management Software system allows for the event to be closed and queued for further trending.

Investigation &
Root Cause Analysis

CQ’s CAPA Management Software provides a strong platform for collaboration amongst the employees from multiple sites. It even allows inclusion of subject matter experts from the supply chain to perform root cause analysis without limiting to personnel within a single department. It can document the relevant root causes, including the supporting tools, and provides documentation and evidence that was used to conclude on the root cause analysis. Investigators can utilize the cloning capability to perform additional investigations and reuse the analysis.

Define Action Plans

CQ’s CAPA Management Software provides a collaborative platform for employees from one or multiple sites to review the results of investigation & root cause analysis to document necessary corrective, preventive and effectiveness verification plans along with their due dates.

Reviews And Approvals

CQ’s CAPA Management Software provides for the ability to route the CAPA record for reviews at various levels and solicit feedback and necessary approvals. Approvers can either be predefined based on the type of CAPA or can be defined dynamically.

Implement

CQ’s CAPA Management Software allows for the plan assignees to implement the approved corrective and preventive action plans. Additional plans can be recorded as deemed necessary to effectively address the root cause and making sure the issue does not reoccur.

Effectiveness Verification
And Closure

Once the CAPA plans are fully implemented, the effectiveness verification process can start and ensure that the addressed events haven’t recurred. Once fully satisfied that the CAPA plans have taken effect, the CAPA can be closed and the information appropriately archived. Effectiveness verification can be scheduled for another review if the CAPA plans are yet to showcase their effectiveness.

Link To
Other Process

CQ’s CAPA is integral to the company’s quality improvement initiative. CQ CAPA Management Software will allow CAPAs to be linked to the other CQ solutions such as Audit Management System, Change, Complaints, and Nonconformance. This linking ensures that both short term and long term resolutions are properly undertaken.

Reports And
Dashboards

CQ CAPA Management Software system provides for standard best practice reports and dashboards to be created and deployed easily. Reports and dashboards provide businesses with the required insights to take appropriate actions promptly.

collaboration

Reach out to others across the enterprise and in the supply chain to solicit feedback without having to give up on the ownership of the tasks.

mobile access

Access your QHSE solution on the go — anywhere, anytime and on any device. Complete access to the solution including reports, approvals, record views, reviews, alerts, etc. ensures business continuity and improves efficiency, visibility and flexibility.

reporting and analytics

Utilize pre-developed best practices based reports. Create any number of additional reports and dashboards to suit your requirement. Information is easily retrievable, helping you make quick decisions.

social like & follow

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

CAPA Management Software Datasheet

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A platform to convert every issue into an opportunity for improvement

Companies are now recognizing the significant impact of quality control on profitability and are taking an enterprise-wide approach to automate CAPA. Companies regulated by FDA or those following standards such as ISO are leading this trend, as they have to follow external mandates on quality management and need to lower their risk of non-compliance across all operations and improve efficiency.

  • Failing to learn from failures.
  • Being reactive to issues rather than proactive.
  • Loss of tribal knowledge when an individual leaves an organization.
  • Difficulties to capture information in a centralized location to make it shareable.
  • Problems in finding an easy methodology to implement the same/similar CAPAs at multiple locations.
  • Loss in learning from historical CAPA investigations to avoid investigating and addressing CAPAs that are similar in nature.
  • Inability to find, report and share data across the value chain to make faster decisions because of the lack of suitable metrics.
  • Too many CAPAs and lack of clarity about priorities and ownership of issues.

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