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CAPA Management

Identify, anticipate, and correct defects and nonconformances that prevent your products or services from meeting customer requirements through the timely execution of appropriate corrective and preventive actions

Configurable Templates

Create customized corrective and preventive action forms, allowing for streamlined and standardized tracking and resolution of issues.

Effective CAPA Management

Facilitates real-time collaboration with involved parties regarding investigations, root cause analysis, corrective and preventive action plans, and their implementation schedules to manage issues quickly

User-Friendly Record Creation

Customize pre-built templates to create CAPA forms as per user’s preference and manage voluminous CAPA records on a centralized platform

Automated Workflow & Reminders

Proceed with the CAPA workflow by assigning the different CAPA activities to individuals with a task due date, which will be followed by each CAPA record respectively

CAPA Management

Identify, anticipate, and correct defects and nonconformances that prevent your products or services from meeting customer requirements through the timely execution of appropriate corrective and preventive actions

Configurable Templates

Create customized corrective and preventive action forms, allowing for streamlined and standardized tracking and resolution of issues.

Effective CAPA Management

Facilitates real-time collaboration with involved parties regarding investigations, root cause analysis, corrective and preventive action plans, and their implementation schedules to manage issues quickly

User-Friendly Record Creation

Customize pre-built templates to create CAPA forms as per user’s preference and manage voluminous CAPA records on a centralized platform

Automated Workflow & Reminders

Proceed with the CAPA workflow by assigning the different CAPA activities to individuals with a task due date, which will be followed by each CAPA record respectively

Manage Complaints, CAPA, Holds & Deviations

Efficient track, resolve, and document customer complaints, corrective and preventive actions (CAPA), product holds, and deviations, ensuring effective quality management and regulatory compliance

Complaint Management

Streamline and resolve customer complaints effectively through comprehensive CAPA management

Hold Management

Systematically track and control product holds to ensure compliance with quality standards and regulatory requirements

Deviation Management

Document, investigate, and resolve deviations from established processes or specifications, facilitating effective root cause analysis and corrective actions

CAPA Management

Streamline the entire corrective and preventive action process, from identification and evaluation of issues to implementation and verification of actions

Manage Complaints, CAPA, Holds & Deviations

Efficient track, resolve, and document customer complaints, corrective and preventive actions (CAPA), product holds, and deviations, ensuring effective quality management and regulatory compliance

Complaint Management

Streamline and resolve customer complaints effectively through comprehensive CAPA management

Hold Management

Systematically track and control product holds to ensure compliance with quality standards and regulatory requirements

Deviation Management

Document, investigate, and resolve deviations from established processes or specifications, facilitating effective root cause analysis and corrective actions

CAPA Management

Streamline the entire corrective and preventive action process, from identification and evaluation of issues to implementation and verification of actions

Investigation & Root Cause Analysis

Implement a thorough investigation and root cause analysis of issues as the most significant part of a CAPA practice in the quality management system to enable users to identify underlying causes and execute appropriate corrective actions for sustained quality improvement

Investigation

Provide a structured approach to conduct detailed inquiries into quality issues, ensuring all relevant information is collected and analyzed to drive effective problem-solving

Root Causes Analysis Technique

Perform root cause analysis using techniques such as 5 Why Analysis, Fish Bone Analysis, etc., to assist users in systematically identifying the fundamental reasons behind problems and preventing recurrence

Documentary Evidence

Allows for the attachment and management of documentary evidence, such as photos, reports, or test results, providing a centralized repository for supporting data during investigations and analysis

Root Cause Trace

Possess a traceability mechanism to link identified root causes to specific issues, ensuring a clear and auditable connection between problems and their underlying causes for improved accountability and decision-making

Investigation & Root Cause Analysis

Implement a thorough investigation and root cause analysis of issues as the most significant part of a CAPA practice in the quality management system to enable users to identify underlying causes and execute appropriate corrective actions for sustained quality improvement

Investigation

Provide a structured approach to conduct detailed inquiries into quality issues, ensuring all relevant information is collected and analyzed to drive effective problem-solving

Root Causes Analysis Technique

Perform root cause analysis using techniques such as 5 Why Analysis, Fish Bone Analysis, etc., to assist users in systematically identifying the fundamental reasons behind problems and preventing recurrence

Documentary Evidence

Allows for the attachment and management of documentary evidence, such as photos, reports, or test results, providing a centralized repository for supporting data during investigations and analysis

Root Cause Trace

Possess a traceability mechanism to link identified root causes to specific issues, ensuring a clear and auditable connection between problems and their underlying causes for improved accountability and decision-making

Non-compliance Management

Organize identification, documentation, and resolution of any deviations from regulatory requirements, internal policies, or quality standards by properly planning the resolution activity, defining and implementing the action plan

Corrective Actions

Assigned users can define and implement specific corrective actions that address the root causes of identified issues, ensuring effective problem resolution and preventing their recurrence

Preventive Actions

Empower organizations to proactively identify and implement measures to avoid potential problems, minimize risks, and promote a culture of continuous improvement

Verification of Effectiveness & Closure

Make the determination whether the CAPA was effective in eliminating or minimizing the cause of the issue through verification procedures and initiate closure

Notification

Automatically alert relevant stakeholders about non-compliance incidents and follow-up remedial actions such as assigning responsible individuals, non-compliance due dates, reviewing, and closure

Non-compliance Management

Organize identification, documentation, and resolution of any deviations from regulatory requirements, internal policies, or quality standards by properly planning the resolution activity, defining and implementing the action plan

Corrective Actions

Assigned users can define and implement specific corrective actions that address the root causes of identified issues, ensuring effective problem resolution and preventing their recurrence

Preventive Actions

Empower organizations to proactively identify and implement measures to avoid potential problems, minimize risks, and promote a culture of continuous improvement

Verification of Effectiveness & Closure

Make the determination whether the CAPA was effective in eliminating or minimizing the cause of the issue through verification procedures and initiate closure

Notification

Automatically alert relevant stakeholders about non-compliance incidents and follow-up remedial actions such as assigning responsible individuals, non-compliance due dates, reviewing, and closure

Reporting and Trend Analysis

Offers wide-ranging data analysis, graphical visualization, and trending capabilities, enabling organizations to identify patterns, monitor performance, and make data-driven decisions for ongoing enhancement in quality and compliance.

System Generated Reports

Generate predefined reports that provide valuable insights into the status, trends, and performance of CAPA processes, offering a quick overview of key metrics and facilitating informed decision-making

Custom Reporting

Create tailored reports with Smart CAPA, allowing for the inclusion of specific data fields, filters, and visualizations, enabling flexible analysis and reporting based on unique business requirements

Exportable Data and Graphs

Export data and graphs in various formats, such as Excel or PDF, providing the versatility to share and utilize information externally or for further analysis.

Scheduled Reports by Email

Automate the delivery of reports to designated recipients at predefined intervals, ensuring timely distribution of critical information and promoting regular monitoring of CAPA performance

Reporting and Trend Analysis

Offers wide-ranging data analysis, graphical visualization, and trending capabilities, enabling organizations to identify patterns, monitor performance, and make data-driven decisions for ongoing enhancement in quality and compliance.

System Generated Reports

Generate predefined reports that provide valuable insights into the status, trends, and performance of CAPA processes, offering a quick overview of key metrics and facilitating informed decision-making

Custom Reporting

Create tailored reports with Smart CAPA, allowing for the inclusion of specific data fields, filters, and visualizations, enabling flexible analysis and reporting based on unique business requirements

Exportable Data and Graphs

Export data and graphs in various formats, such as Excel or PDF, providing the versatility to share and utilize information externally or for further analysis.

Scheduled Reports by Email

Automate the delivery of reports to designated recipients at predefined intervals, ensuring timely distribution of critical information and promoting regular monitoring of CAPA performance