CAPA – Corrective and Preventive Action Management

Track and Manage your CAPA( Corrective and Preventive Action) Management for continuous improvement

AmpleLogic CAPA Planning or CAPA Tracking software helps regulated companies in all pharma and life science companies automate and streamline the entire corrective action, corrective action tracking, and corrective action resolution process

CAPA (Corrective and Preventive Action) leads other critical Quality Management Systems like Deviation, Change Control, and Training for continuous improvement and effectiveness of all Life Sciences companies. So Corrective and Preventive Action Management and its analysis is core to the effectiveness of all other Quality Management Systems and critical for GMP compliance or regulated environments.

Therefore, the current paper-based Corrective and Preventive Action lacks in establishing transparency between CAPA System to Quality Management Systems across the departments, which can affect their effectiveness. Thereby leaving scope for an ineffective Corrective and Preventive Action Management approach and need for effective CAPA solution or software.

21 CFR Part 11 Complaint CAPA Tracking Software

This CAPA Management and Tracking Software are fully designed to integrate with other quality systems such as Deviations and manage corrective action/ preventive action from initiation to CAPA closure but not limited to Audits. The Corrective and Preventive Action software streamlines your Root Cause Analysis, CAPA proposal, Approval, Implementation,  Effectiveness Review, and also Closure by automating with industry best practices by providing tractability, tracking the status and overdue controls across quality systems.

Because with flexibility in configuring its workflow processes, it is very easy for the Corrective and Preventive Action tracking software to be re-defined into your current process within a short period. In-depth of analysis, it’s trending are made available at the single click of a button with detailed summary reports and metrics reports.

Therefore, the summary report gives you real-time visibility of the information within the current CAPA record and its metrics reports bring high visibility in the status of CAPAs and their systems (i.e open, closed, overdue, in progress, etc.) across the organization at any given date of time.

Besides these providing the best approach for CAPA effectiveness check, this solution is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing complete audit trails, e-signatures, controlled printing, controlled access, records management and also archival in accordance to regulatory standards and policies of an organization.

Advantages with CAPA Management Software and Tracking

This CAPA Tracking software system or Planning Software was developed based on extensive research of Corrective and Preventive Action guidelines from various regulatory agencies and yet be flexible to seamlessly integrate into other quality systems and manage CAPAs effectively with these core benefits:

  • The web-based approach allows CAPA Planning software accessibility from anywhere within the site or organization
  • Designed to be flexible in establishing linkage to other Quality Systems
  • Robust analysis of Root Cause accelerates the investigation phase
  • Disintegrating Corrective and Preventive Action into CAPA Tasks enables efficiency in routing, review, and implementation
  • Corrective and Preventive Action effectiveness review through assignable effectiveness checks enable multi-tasking and in-depth visibility
  • Metrics Reports or Trends that are exclusively analytical and visually eye-catching
  • Integration and linking capabilities to other Quality System that ensure seamless traceability

Apart from being an industry standard and effective CAPA Management Software Solution, the system has several key features that are practical and problem-oriented.

Key Features of CAPA Tracking Software

Robust Root Cause Analysis

The Root Cause Analysis allows tasks assigned to the investigators and across the departments based upon the criticality of the observation. These investigators, in turn, can create tasks and send to participants for a response. The responses are evaluated for identification of root cause and submitted for Corrective and Preventive Action Proposal. Due dates set ensure targeted closure of tasks and auto escalation upon overdue maintains the nature of the Root Cause Analysis to be robust and effective.

Quality System Linkage

The relevant information of an observation from the source Quality System is automatically captured at the initiation eliminating the rework of observation data entry. Also, the linkage allows closed-looping of Quality System with their Management. Linking the Corrective and Preventive Action with the Audit Observations, Incident, Deviations and Change Control.

CAPA Plan and Tasks

This is initiated by summarizing the Corrective and Preventive Action Plan and disintegrating this plan into a series of corrective action/ preventive action tasks that can be routed for review and approvals. Each of its tasks is set with a target date and responsibility to an assignee which allows the system to trace and track the task completion enabling targeted closure and auto escalation with overdue controls.

CAPA Predecessor

This is a unique CAPA Planning software feature built-in with an understanding that all Corrective and Preventive Action tasks cannot always be implemented sequentially and there is dependability among corrective actions/ preventive actions. The system ensures that the selected tasks are implemented only upon completion of the predecessor task(s).

Automated Alerts and Notifications

This Planning and Tracking software feature ensures that users are automatically communicated at defined frequencies and at defined workflow steps about the approaching target date for required actions. Users are notified directly through follow-up e-mails that are sent automatically to the user e-mail account. Besides the system auto escalates the overdue and helps resolve the issue.

CAPA Effectiveness Checks

Its effectiveness is reviewed through effectiveness checks that can be flexibly added prior to their implementation. The solution allows tracking of these checks and closure of Corrective and Preventive Action was as effective or not.

Industries that can benefit from our 21 CFR Part 11 Software

  • Pharmaceuticals
  • Biotechnology
  • Biologics
  • Medical Devices
  • Chemical
  • Contract Manufacturing
  • General Manufacturing
  • Food & Beverages
CAPA - Corrective and Preventive Action
Corrective and Preventive Action