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
ANALYZE	820(a)(1) 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
INVESTIGATE	820(a)(2) 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
IDENTIFY	820(a)(3) 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
VERIFICATION & VALIDATION	820(a)(4) 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
IMPLEMENT	820(a)(5) 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
DISSEMINATE	820(a)(6) 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
MANAGEMENT REVIEW	820(a)(7) 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
DOCUMENT	820(b) 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