Corrective and Preventive Action Process Scenario
CAPA, Corrective and Preventive Action leads other critical Quality Management Systems like Deviations, Change Control, and Trainings for continuous improvement and effectiveness, Life Sciences companies. So CAPA management and analysis is core to the effectiveness of all other Quality Management Systems and critical for GMP compliance or regulated environments. The current paper based CAPA lacks in establishing transparency between CAPA System to Quality Management Systems and across departments, which can affect CAPA effectiveness. There by leaving scope for an ineffective CAPA Management approach and need for effective CAPA solution or CAPA software.
21 CFR Part 11 Complaint CAPA Tracking Software
This CAPA Management and Tracking Software is designed to fully integrate with other critical quality systems such as but not limited to Audits, Deviations and manage corrective action/ preventive action from initiation to CAPA closure. The CAPA software streamlines Root Cause Analysis, CAPA proposal, CAPA Approval, CAPA Implementation, CAPA Effectiveness Review and CAPA Closure by automating with best practices of the industry, providing traceability across quality systems, status tracking and overdue controls.
With flexibility in configuring CAPA process workflows it is easy for the CAPA Tracking software to be re-defined into your current CAPA process within in a short period. In-depth CAPA analysis and CAPA trending is made available at the click of a button with Summary Reports and Metrics Reports. Summary Report gives real-time visibility of the information within the current CAPA record and metrics reports brings high visibility in status of CAPAs and the CAPA system (open, closed, overdue, in progress etc.) across the organization on any given date.
Besides providing best approach for CAPA effectiveness check , the solution is in total compliance with electronic records and management regulations such as 21 CFR Part 11, by providing audit trails, e-signatures, controlled printing, controlled access, records management and archival in accordance to regulatory standards and policies of an Organization.
Advantages with CAPA Automation and Tracking
This CAPA Tracking software system was developed based on extensive research of CAPA guidelines from various regulatory agencies and yet be flexible to seamlessly integrate into other quality systems and manage CAPAs effectively with these core benefits:
- Web based approach allows CAPA 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 CAPA into CAPA Tasks enables efficiency in routing, review and implementation
- CAPA 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 solution, the system has several key features that are practical and problem oriented.
CAPA Tracking Software Key Features
Robust Root Cause Analysis
The Root Cause Analysis allows tasks assignment to the investigators and across the departments based upon criticality of the observation. These investigators in turn can create tasks and send to participants for response. The responses are evaluated for identification of root cause and submitted for CAPA 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 CAPA initiation eliminating the rework of observation data entry. Also the linkage allows closed-looping of Quality System with the CAPA Management. Linking the CAPA with the Audit Observations, Incident, Deviations and Change Control.
CAPA Plan and CAPA Tasks
CAPA is initiated by summarizing the CAPA Plan and disintegrating this plan into a series of corrective action/ preventive action tasks that can be routed for review and approvals. Each CAPA task 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.
This is a unique CAPA software feature built-in with an understanding that all CAPA 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 predecessor task(s).
Automated Alerts & Notifications
This CAPA 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
The CAPA effectiveness is reviewed through effectiveness checks that can be flexibly added prior to CAPA implementation. The solution allows tracking of these checks and closure of CAPA was as effective or not.
Industries that can benefit from our Solution
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages