ExtraView CAPA Functionality Matrix


This table provides an overview of each of the prescribed steps for issue management and the resulting CAPA process, should it be necessary, in order to resolve a problem. The regulation references are specific to 21 CFR Part 820 but the process also addresses EU Pharmacovigilance legislation and guidelines, ISO standards, GxPs, and Quality by Design objectives. ExtraView may be the sole solution used to manage the entire CAPA process.  Alternatively, where other tools are already installed to support part of the process, ExtraView works cooperatively with those systems, either as a source of information and data, or as a consolidator of that data. ExtraView's ease-of-use, rich built-in reporting capabilities, and intuitive configuration provide a significant advantage over all other tools.


Process Regulation Interpretation ExtraView's Role Complementary Tools





Analyzing processes, work operations, concessions, quality audit reports, quality records, service records, complaints, returned product, and other sources of quality data to identify existing and potential causes of nonconforming product, or other quality problems. Appropriate statistical methodology shall be employed where necessary to detect recurring quality problems

  • Triage
  • Problem Identification
  • Signal Management
  • Risk Analysis
  • Logging of issues and workflow around the issues - e.g. defects, complaints, AEs, regulatory findings, quality or process exceptions
  • Risk Assessment / process and resulting determination of whether issue should generate a CAPA
  • Capture of decision
  • Creation of CAPA if appropriate
  • Quality System
  • AE System
  • Pharmacovigilance Master File
  • Audit System
  • Customer complaint system
  • Product defect tracking
  • Risk Management Plans
  • Metrics





Investigating the cause of nonconformities relating to product, processes, and the quality system


Root Cause Analysis

  • Minimally, capture Root Cause Analysis Results
  • "5 Whys" and / or Process Definition steps to determine where breakdown occurred
  • End-to-end, inclusive process to examine and record all interrelated facts
  • Reality Charting
  • Apollo Charting Root Cause Analysis Tool
  • Trackwise
  • Intellex
  • Sologic





Identifying the action(s) needed to correct and prevent recurrence of nonconforming product and other quality problems


Define Corrective Actions of CAPA

  • Capture all Corrective / Preventive Actions and relationships
  • Perform Risk Analysis again to prioritize against body of CAPAs
  • Communicate the results to all stakeholders
  • EtO
  • Trackwise
  • Pilgrim Software
  • Other quality management systems





Verifying or validating the corrective and preventive action to ensure that such action is effective and does not adversely affect the finished device or product


IQ / OQ / PQ

  • Document expected results of CAPA and how they address root cause(s) – effectively and completely
  • Document that process was tested and didn’t introduce other quality issues
  • Document actual results of CAPA at close
  • Quality and or test systems may store test plans and test results while ExtraView also captures that the planning and testing was completed and was effective






Implementing and recording changes in methods and procedures needed to correct and prevent identified quality problems


Execution of Corrective or Preventative Actions

  • Reference link to updated document or process and or change management / audit record of update made in source systems
  • ExtraView may be the workflow engine to record all the implementation steps, ensuring that the quality process is followed faithfully
  • Report to all stakeholders on the progress of all implementation steps
  • Escalate changes that are not progressed in a timely manner
  • Wherever source documents exist for SOPs, Requirements, Manufacturing processes, Testing requirements – dependent on change






Ensuring that information related to quality problems or nonconforming product is disseminated to those directly responsible for assuring the quality of such product or the prevention of such problems


Ensure Good Communications

  • Workflow, tracking of communications, training, etc. related to CAPA.  May reference back to source system for training or communications or may store content within ExtraView
  • ExtraView provides an extensive range of reports to ensure the stakeholders are informed of progress
  • Reports can be complete or on an exception basis and are automatically routed to the parties concerned with any specific issue
  • Training systems
  • Communication systems







Submitting relevant information on identified quality problems, as well as corrective and preventive actions, for management review


Obtain Sign Off

  • Workflow and sign-off of Management Oversight, related to capture of ownership and oversight as part of managing Problem Identification and CAPA if applicable
  • Management review can include electronic signatures at any stage in the process
  • Reports can be scheduled for transmission to management on a periodic basis







All activities required under this section, and their results, shall be documented


Ensure Auditability of Results

  • This is captured automatically within ExtraView in the above steps
  • This is the objective evidence that the process was followed to completion
  • Where source documents are stored outside of ExtraView, e.g. in a document repository, this can be linked to ExtraView, and ExtraView can track the details of all updates