Corrective Action (CAPA) Tracking Software
AmpleLogic CAPA Tracking Software that investigates systems intricately in order to find errors and problems. This software also helps in solving these problems by identifying them and taking necessary corrective measures to prevent any future re occurrence. AmpleLogic CAPA Tracking Software in Life sciences is developed to primarily ensure that problems militating against quality management are never experienced again. However, biotechnology, life sciences, pharmaceuticals, and other health industries have been compelled by regulatory bodies to include CAPA in their QMS as this feature improves product effectiveness greatly.
AmpleLogic CAPA is a vital tool for a set of techniques and tools needed for better comprehension of business processes used to design new pharma products or redesign existing ones. Both features make use of similar processes and analytical tools, but they have been designed to be used independently or together. It is more transparent and efficient than paper-based CAPA for use in pharmaceuticals, medical device development, life sciences, etc.
This Corrective Action aids identification and elimination of the root cause of a problem to prevent its recurrence, preventive action as the name implies, prevents potential occurrences, it is said to be proactive.
There are 3 important steps in a CAPA system
Identifying the root cause of a problem
A root cause is a factor that caused a non conformance and should be eliminated through a process or system improvement. A proper root cause Analysis will help to determine the 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 to take appropriate action in time.
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.
It is more transparent and efficient than paper-based CAPA for use in pharmaceuticals, medical device development, life sciences, etc.
21 CFR Part 11 Complaint CAPA Tracking Software
AmpleLogic CAPA Tracking Software is designed specifically for pharmaceuticals, life sciences, biotech companies and other FDA- regulated industries. This tracking software necessitate that these companies implement controls including audits, system validations, audit trails, electronic signatures, and documentation. They are designed to work with multiple systems like deviations and also manage corrective action / preventive action from initiation to CAPA closure.
21 CFR Part 11 is divided into three sub-parts:
The General Provisions section generally discusses the scope of regulations, when and how it should be implemented and defines some of the key terms used in the regulations.
The Electronic Records section depicts the requirements for administration of closed and open electronic record-keeping systems, then discusses signature manifestations and requirements for establishing a link between signatures and records.
Lastly, the Electronic Signatures section is split into three parts also: general requirements for electronic signatures, electronic signature controls and components and controls for identification codes/passwords.
In summary, 21 CFR Part 11 provides an opportunity for medical device companies to finally reap the organizational benefits of paperless record-keeping systems for its reliability as it is not debatable. It also enable the FDA make certain that when medical device companies use electronic record-keeping systems, document security and authenticity are adequately maintained. Hence, it helps the FDA monitor document security and authenticity.
It is often argued that these regulations of 21 CFR part 11 places additional burden of regulation for industries. However, the significant benefits of this electronic system is numerous and they help the FDA ensure appropriate regulation activities in the following ways:
- Easy access to electronic records is limited to authorized individuals
- For account sharing between individuals, groups or departments is not permitted
- Ensure adequate security protocols are followed to ensure the integrity of passwords and login credentials for all users
- Electronic signatures cannot be transferred or copied between documents
- Electronic signatures are certified to be the same as handwritten signatures, and that the certification is mailed to the FDA
- Records are tracked through document controls and an audit trail that monitors changes and discerns invalid or altered records
All in all, this solution ensures that the quality management system of products stay in accordance to regulatory standards and policies of an organization.
Advantages with CAPA Management and Tracking System
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
- 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 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.
Integrating with Quality Systems
- 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 can be interlinked with any module in QMS. If the user is navigating from any module to CAPA, the data of that module shall be auto copied in the linked CAPA by the system.
CAPA Scheduling, Plan and Action Items
- 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.
- If the CAPA is not approved within the provided date, the system shall ask for Justification.
- If the action items are not completed within time line extension is made mandatory by the system.
- 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 AmpleLogic 21 CFR Part 11 Software
- Medical Devices
- Contract Manufacturing
- General Manufacturing
- Food & Beverages