CAPA Software for Life Sciences Industry
CAPA Software requirements for FDA-regulated pharmaceutical companies stipulated in 21 CFR Part 11, states “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action.” For Pharma companies under quality system inspection technique (QSIT), an FDA inspection will always include an inspection of a company’s CAPA system.
According to the CGMP guidelines, Corrective Action involves the act of identifying and eliminating the root cause of a problem with the goal of preventing the problem from recurring in the future. Preventive action, other the other hand, involves the steps taken by an organization to prevent potential problems.
There are 3 important steps in a Life sciences CAPA system
Identifying the root cause of a problem
A root cause is a factor that results in non-conformance and should be eliminated through a process or system improvement. Organizations must adopt a solid process for root cause analysis which supports the determination of corrective actions to avoid or significantly reduce the recurrence of the identified problem.
It is very Important to investigate the effect of a non-conformity on product quality to identify the severity level of the problem and to take appropriate action in a timely manner
Recommending the CAPA
An Appropriate Corrective Action should be suggested to eliminate the cause of detected non‐ conformity or other undesirable situation. Also, based on the Analysis, preventive actions should also be taken to avoid occurrence of potential non‐conformity.
Challenges with manual CAPA Management in Pharmaceutical Industry
- Need to maintain manual CAPA register and have control on CAPA form issuance and reconciliation. This is labor intensive.
- Extensive Manual follow-up is required to determine status and ensure the CAPA is progressing.
- Target dates may be missing due to manual checking of the logs
- The process is difficult to execute consistently due to lack of control.
- Lack of accountability from employees due to poor management visibility on the reasons for delay.
- Tracking depending areas like deviations, Observations, Complaints against a CAPA
- Challenges in arriving at repetitive CAPAs
- Keeping Track of CAPA Effectiveness check dates is challenging
- Lack of expertise to determine the definition of CAPA and Root Cause
AmpleLogic CAPA Automation Software designed for the Lifesciences Industry, helps in addressing real-time problems in the pharmaceutical and Biotech industry in compliance with Regulatory and Process Standard Requirements. The software helps organizations to manage all the CAPA action timely & effectively with integration with other modules like OOS, OOT, Change Control, Deviation, Audit, Market Complaints etc. It allows business users to perform the CAPA life cycle through the system from CAPA initiation till closure.
AmpleLogic CAPA Software allows you raise the Corrective or preventive actions from Deviations, OOS investigation
CAPA Tracking Software Features
- CAPA can be initiated independently or from various resources like Planned & Unplanned deviation, Market complaints, incidents, internal& customer audits findings, Out of trends analysis, Self-inspection/ External Audits, Annual Product Quality reviews, Recommendations of executed validations
- Provision to select type of CAPA e.g. New CAPA or reopen CAPA and selection of multiple sources of 1 CAPA
CAPA Evaluation and Robust Root Cause Analysis
- Detailed CAPA evaluation Process by communicating and circulating to necessary dept. HOD’s, Cross functional Teams or GMP committee members through an activity definition, by email and auto reminders.
- The software helps users assign the RCA tasks to investigators and other personnel across different 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.
- With the help of the due-date feature, users can identify a time frame for completing the tasks. The system automatically escalates overdue tasks to improve efficiency and support faster closures.
Integrating with Quality Systems
- CAPA can be interlinked with other eQMS modules like Audit Observations, Incidents, Deviations and Change Control
- Conditional closure of Deviations, and Audit Observations based on CAPA Closure
- Triggering training need in LMS (learning Management Software) from Preventive Action Items.
CAPA Scheduling, Plan and Action Items
- Summarizing the Corrective and Preventive Action Plan and creating tasks related to corrective or preventive action which can be sent to appropriate users 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 monitor the completion of a task. This feature is useful in improving closure time frames which are further reinforced through auto escalation and overdue controls.
- If the CAPA is not approved within the provided date, the system shall ask for Justification.
- If the CAPA action items are not completed within timeline, extensions are made mandatory by the system.
- This is a unique CAPA Planning software feature built-in with an understanding that all CAPA tasks must have a certain amount of flexibility in the sequence in which they are completed since a task may depend on the completion of another task before it can be implemented.
- The system ensures that the selected tasks are implemented only upon completion of the predecessor task(s).
Automated Alerts and Notifications
- This CAPA Planning and Tracking software feature ensures that users receive automatic alerts and notifications at defined workflow steps and at pre-defined frequencies. The emails share information related to approaching target date for specific tasks.
- Employees will be notified directly through follow-up e-mails that are sent automatically to the user e-mail account.
CAPA Effectiveness Check
- CAPA effectiveness is reviewed through effectiveness checks by setting Periodic Reviews
- The solution allows tracking of these checks and to identify if the closure of Corrective and Preventive Action was effective or not.
- Ineffective CAPA’s trigger a new CAPA
CAPA Reports and Dashboards
- Dashboard, Analytics and Reporting of CAPAs. A typical Report includes Effective CAPA, Ineffective CAPA, Repetitive CAPAs, Delayed CAPAs, Rejected CAPAs. Yearly, and Monthly reports can be generated for each process type.
- Dynamic reports to check the dependency and linking with other modules as per US FDA quality modules
CAPA Management and Tracking System Benefits in GMP Environments
- The web-based approach allows CAPA Planning software accessibility from anywhere within the site or organization
- Automatic initiation of CAPA in case of any deviation and occurrence of Quality issues to ensure consistency and reliability.
- 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 smaller tasks which can be carried out by the investigators with higher efficiency. It improves routing, review, and implementation
- Reviewing CAPA effectiveness with the help of effectiveness checks which provide in-depth visibility
- Metrics Reports or Trends that are exclusively analytical helps the management in Process Performance Review and CAPA effectiveness
- Integration and linking capabilities to other Quality System that ensure seamless traceability
Apart from being an industry standard and effective CAPA Software Solution, AmpleLogic CAPA software allows easy configuration of additional features that are practical and problem-oriented.
Our CAPA Tracker will also comply with electronic Record standards defined by TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA and MoH
Other industries that can take advantage of CAPA Automation Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages