CAPA Management Software
Every pharmaceutical company undergoes a quality system inspection method (QSIT), which involves an examination of the company’s CAPA system. Its requirements for FDA-regulated pharmaceutical firms are stated in 21 CFR part 11, which specifies that “each manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.
Corrective Action, according to the CGMP standards, is the process of finding and removing the underlying cause of a problem to avoid the problem from happening again in the future. Preventive action, on the other hand, refers to the steps taken by a company to avoid possible complications.
A Life sciences CAPA system consists of three crucial stages:
Identifying the root cause of a problem
A root cause is a component that contributes to nonconformance and should be eliminated through a process or system improvement. The root cause analysis approach used by a company must be solid. This approach is meant to aid in the identification of corrective steps that will avert or significantly reduce the recurrence of the problem.
The next step is to analyze the impact of nonconformity on the quality of the product and to determine the magnitude of the problem. Following that, necessary action should be taken as soon as possible.
Recommending the CAPA
The final stage is to propose appropriate corrective action. This is done to remove the root cause of the identified nonconformity or other unpleasant conditions. In addition, depending on the analysis, preventative measures should be implemented to avoid the occurrence of probable nonconformity.
Challenges with manual CAPA Management in Pharmaceutical Industry
- Controlling the issue and reconciliation of CAPA forms, as well as the labor-intensive maintenance of a manual CAPA register
- Evaluation of status and development of a CAPA involves substantial manual monitoring
- Deadlines and targets may be may difficult to meet as a result of manual log review
- Lack of control makes it harder to carry out the procedure consistently
- Employees are not being held accountable for the causes for the delay as a result of limited managerial visibility
- Tracking based on factors such as deviations, observations, and complaints filed against CAPA
- The problem of getting recurrent CAPAs
- It is hard to keep track of the dates of CAPA effectiveness checks
- Inability to define CAPA and Root Cause due to the lack of competence.
AmpleLogic CAPA Automation Software
As a result of AmpleLogic’s CAPA Automation Software, the pharmaceutical and biotech industries are now able to solve real-time problems promptly. It fulfills the requirements of the Regulatory and Process Standard Requirements. By integrating additional modules such as OOS, OOT, Change Control, Deviation, Audit, Market Complaints, and so on, the software enables businesses to handle all CAPA activities in a timely and effective manner.
Business users may also utilize the system to complete the CAPA life cycle, from start to finish.
From deviations to OOS investigations, the AmpleLogic CAPA Management Software allows you to develop corrective or preventive measures.
Features of the CAPA Tracking Software
- CAPA can be conducted autonomously or from different resources such as planned and unplanned deviations, market complaints, incidents, internal and customer audit findings, out of trends analysis, self-inspection/external audits, annual product quality reviews, and recommendations of executed validations.
- There is an option to pick the kind of CAPA (e.g., new CAPA or reopen CAPA) as well as many sources for a single CAPA.
CAPA Evaluation and Robust Root Cause Analysis
- Through the use of an activity definition, email, and auto-reminders, the software offers a thorough CAPA assessment process by notifying and circulating to the appropriate department heads, cross-functional teams, and members of GMP committees.
- Based on the severity of the report, the program helps users in assigning RCA duties to investigators as well as other individuals from other departments. In turn, these investigators can develop assignments and assign them to participants for completion. The replies are analyzed to determine the root cause and then presented for Corrective and Preventive Action Proposal.
- The system has a due-date function that allows users to set a deadline for finishing activities. To increase productivity and facilitate speedier resolutions, the system automatically escalates outstanding jobs.
Integrating with Quality Systems
- CAPA has connectivity compatibilities with other eQMS modules such as Audit Observations, Incidents, Deviations, and Change Control
- They can as well be conditional deviation closures or Audit Observations based on CAPA resolution
- Preventive Action Items can be used to prompt the requirement for training in an LMS (Learning Management Software).
CAPA Scheduling, Plan and Action Items
- It highlights the Corrective and Preventive Action Plan and assigns responsibilities to corrective or preventive action. These duties can then be distributed to the relevant people for evaluation and approval
- To track and monitor the completion of each assignment, the system assigns a due date and assigns responsibility to a designated person. When used in conjunction with auto-escalation and overdue controls, this functionality improves closure time frames
- If the CAPA is not approved within the specified time frame, the system will ask for an explanation
- If CAPA action items aren’t accomplished within the set timeframe, the system will require an extension of time to complete them.
- In order for CAPA tasks to be completed within a reasonable timeframe, this unique software feature was designed to allow for some amount of freedom in the order they are executed. The execution of one job may be reliant on the completion of another.
- The system guarantees that the specified tasks are only carried out once the preceding tasks has been completed.
Automated Alerts and Notifications
- This CAPA planning and monitoring software feature allows users to receive automated alerts and notifications at defined workflow phases and predetermined intervals. Information about upcoming deadlines for certain assignments is included in the emails.
- Employees will receive follow-up emails automatically in their inboxes to notify them.
CAPA Effectiveness Check
- Periodic Reviews are used to assess the efficacy of CAPAs
- The solution provides for the tracking of these inspections and the determination of whether or not the closure of Corrective and Preventive Action was effective
- Ineffective CAPAs necessitates the creation of a new CAPA.
CAPA Reports and Dashboards
- This includes the dashboard, statistics, and CAPA reporting. Effective CAPA, Ineffective CAPA, Repetitive CAPAs, Delayed CAPAs, and Rejected CAPAs are all common components of a report. Reports may be created on a yearly and monthly basis for every process type.
- There are also dynamic data available to examine the dependence and link with other modules, such as the US FDA quality modules.
Benefits of CAPA Management and Tracking System in GMP Environment
- From any location inside a site or organization, CAPA Planning software can be accessed over the internet
- In the event of a deviation or incidence of Quality problems, CAPA is automatically initiated. Consistency and dependability are ensured by this method
- The system is created in such a way that it may be easily integrated with other quality systems
- The investigative stage is accelerated by a thorough study of the root cause
- Smaller activities, which may be carried out more efficiently by investigators, are broken down into corrective and preventative actions. Routing, review, and implementation are improved
- Efficacy checks, which give in-depth visibility, can be used to assess the effectiveness of CAPAs
- Reports or market dynamics that are solely analytic are provided by the software’s metrics. In terms of Process Performance Review and CAPA efficacy, this is a great tool for management
- Integration options with other Quality Systems are provided, ensuring that there is smooth monitoring
Additionally, the AmpleLogic CAPA Management Software provides for easy setup of additional features that are practical and problem-oriented in addition to being an industry-standard CAPA software solution.
TGA, CDSCO, HEALTH CANADA, MCC, ANVISA, EMEA, SFDA, NAFDAC, MEDSAFE, MHLW, MCAZ, SWISSMEDIC, KFDA, and MoH electronic record requirements are also met by our CAPA Tracker.
Other industries that can take advantage of CAPA Automation Software include:
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages
Please contact us for more information on how AmpleLogic Corrective and Preventive Action Software may assist your company.