CAPA Management Software
Corrective Action and Preventive Action Software
Drive Continuous Improvement of Pharma Operations
Ensure Streamlined CAPA Management
AmpleLogic Pharma CAPA Management software offers comprehensive management of corrective and preventive actions in the pharmaceutical environment. According to US FDA 21 CFR Part 11, “each pharma manufacturer shall establish and maintain procedures for implementing corrective and preventive action”.
Every pharma company goes through quality system inspection method (QSIT) which involves examination of the organization’s CAPA system. 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.
Why AmpleLogic CAPA?
AmpleLogic Corrective Action Preventive Action (CAPA) software empowers pharmaceutical and biotech industries to seamlessly manage CAPA life cycle, from start to finish. This helps address real-time quality issues efficiently, meeting stringent regulatory and process standards like FDA 21 CFR Part 820, ISO 13485, ICH Q10, EW GMP Guidelines, WHO GMP, etc. AmpleLogic CAPA software fulfils the Regulatory and Process Standard Requirements.
By integrating additional QMS modules such as OOS, OOT, Change Control, Deviation, Audit, and Market Complaints, the software centralizes CAPA activities for streamlined and timely management. The software is built to take care of the entire CAPA lifecycle from initiation to resolution—ensuring effective corrective and preventive measures.
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Quality Related Challenges in Pharma
Complex Form Handling
Manual CAPA form tracking is labor-intensive, error-prone, and makes the process inefficient.
Status Monitoring Burden
Progress tracking demands significant manual input, risking delays due to outdated information.
Difficulty Meeting Deadlines
Lack of automated reminders can lead to missed deadlines, increasing compliance risks.
Inconsistent Control
Variability in manual processes hinders consistent CAPA execution and effectiveness.
Limited Managerial Oversight
Managers lack real-time visibility, making accountability and delay management difficult.
Recurring Issues
Lack of automated root cause insights can lead to repeated CAPA problems, impacting compliance.
Stages of AmpleLogic CAPA Management
This process focuses on investigating and determining the underlying cause of a nonconformance or issue within CAPA. By identifying the root cause, organizations can implement targeted corrective and preventive actions to prevent recurrence, ensuring compliance and continuous improvement in quality and processes. Root cause analysis tools like the “5 Whys,” Fishbone Diagram, and Failure Mode and Effects Analysis (FMEA) are often utilized in this step to thoroughly assess contributing factors.
Impact assessment in CAPA evaluates the potential effects of issues on product quality, compliance, and efficiency. This process prioritizes CAPA activities by assessing risk severity and likelihood, ensuring corrective and preventive actions target high-impact areas to enhance product safety and regulatory compliance.
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.
Unlock Efficiency with AmpleLogic CAPA Features
Automated CAPA Initiation
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.
CAPA Evaluation
Streamlines CAPA assessment with activity definitions, email, and auto-reminders, notifying department heads, cross-functional teams, and GMP committees. Based on report severity, it assigns RCA tasks to investigators, who then delegate tasks for root cause analysis and CAPA proposals.
Seamless Integration
Integrates with QMS modules like Audit Observations, Incidents, Deviations, and Change Control, allowing conditional closures based on CAPA resolution. Preventive actions can also trigger training needs in an LMS
CAPA Scheduling
Assigns CAPA to designated individuals for evaluation and approval, setting due dates and responsibilities. With auto-escalation and overdue controls, it tracks progress, improving closure times. If actions aren’t completed or approved on time, the system prompts for explanations or time extensions
Predecessor Functionality
Allows flexibility in task execution order, ensuring that dependent tasks are completed sequentially, so each task begins only after its prerequisite is fulfilled.
Automated Alerts
Sends automated alerts and notifications at key workflow stages, including reminders of upcoming deadlines, ensuring employees stay informed with follow-up emails in their inboxes.
CAPA Effective Checks
Periodic reviews assess CAPA effectiveness, tracking inspections to confirm successful closure. If a CAPA is ineffective, a new one is initiated.
CAPA Reporting
Includes dashboards, statistics, and reporting on Effective, Ineffective, Repetitive, Delayed, and Rejected CAPAs. Reports can be generated monthly or yearly for each process type, with dynamic data linking to other modules, including US FDA quality standards.
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Frequently Asked Questions
What industries can benefit from AmpleLogic CAPA Management?
Industries such as pharmaceuticals, biotechnology, medical devices, contract manufacturing, chemical industry, food & beverages, and others with quality assurance needs can benefit from AmpleLogic CAPA Management.
How does AmpleLogic CAPA streamline the corrective action process?
AmpleLogic CAPA streamlines the corrective action process by automating CAPA initiation, facilitating thorough evaluations, integrating with other quality management systems, proactive scheduling, providing predecessor functionality, automated alerts, effectiveness checks, and comprehensive reporting.
Can AmpleLogic CAPA integrate with other quality management systems?
Yes, AmpleLogic CAPA can integrate seamlessly with other quality management systems, including modules for audit observations, incidents, deviations, change control, and more, ensuring streamlined quality management across the organization.
What are the key features of AmpleLogic CAPA Management?
The key features of AmpleLogic CAPA Management include automated CAPA initiation, thorough evaluation process, seamless integration, proactive scheduling, predecessor functionality, automated alerts, effectiveness checks, and comprehensive reporting.
How does AmpleLogic ensure compliance with regulatory requirements in CAPA management?
AmpleLogic ensures compliance with regulatory requirements in CAPA management by providing features such as automated initiation from various sources, comprehensive evaluations, integration with regulatory modules, proactive scheduling, predecessor functionality, and comprehensive reporting. Additionally, the software is designed to meet the requirements of regulatory bodies such as the FDA and other international regulatory agencies.
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