Enabling a digital quality ecosystem to deliver the promise of proactive quality
The world’s first AI-enabled platform designed to augment quality management decision-making
End-to-end solution for enterprise quality management
Modernize the Annual Product Quality Review (APQR) process
A library of business applications, each designed to meet a specific life sciences use case
Root cause analysis (RCA) is the process of drilling down to find the causes of the problem so corrective and preventive action can be taken. While there are multiple benefits to an RCA process, the main benefit allows an employer to discover the underlying or systemic problem to help prevent future occurrences, rather than the generalized or immediate causes of an incident. Learn how a holistic, predictive and proactive CAPA system fosters improvements continuously.
QMSs can help organizations manage CAPA by providing tools and functionality to identify and report issues or defects, investigate root causes, implement CAPAs and monitor the effectiveness of those actions. A QMS can also provide visibility into the status of CAPA activities, enabling organizations to make informed, data-driven decisions to reduce risk and improve quality.
Overall, using technology for CAPA management can help quality managers work more efficiently and effectively, improving the overall quality and safety of their products or services, while also reducing the risk of non-compliance and other issues. While there may be some upfront costs and disruption associated with implementing CAPA management software, the benefits of doing so far outweigh the costs in the long run.
As a quality manager in a regulated industry such as pharmaceuticals or medical devices, one of your most significant concerns is ensuring that your organization maintains compliance with industry regulations. One of the critical aspects of this process is the ability to effectively manage Corrective and Preventive Actions (CAPA).
CAPA is a complex and often challenging process that requires collaboration and communication across multiple departments and stakeholders. As a quality manager, you may face various business problems that make it difficult to manage CAPA effectively. For example, you may struggle with tracking and documenting CAPA activities, identifying and addressing root causes and ensuring timely completion of corrective actions.
Implementing CAPA management software can help you address these challenges. By centralizing and automating the CAPA process, software solutions can improve efficiency, reduce errors, and streamline workflows. CAPA management software can also provide real-time visibility into CAPA status, progress, and results, making it easier for quality managers to track progress and ensure compliance.
For example, suppose a quality manager in the pharmaceutical industry is struggling to manage the CAPA process effectively, with multiple corrective actions being tracked across different departments and locations. In that case, CAPA management software could help them streamline the process, ensure timely completion of corrective actions, and track the implementation of preventive actions to reduce the likelihood of similar issues occurring in the future. Similarly, a quality manager in the medical device industry could use CAPA management software to identify and address root causes of quality issues, ensure timely completion of corrective and preventive actions, and demonstrate compliance with industry regulations and standards.
The risks associated with poor CAPA management can include the continuation of defects or problems that can impact the quality of products or services, and the potential for noncompliance with industry regulations and standards.
CAPA management is the core of an organization’s enterprise quality management system (EQMS). FDA, ISO, EMA and other regulations and standards mandate a systematic approach to managing quality issues and resolutions.
Organizations must log events and problems, investigate them to determine root cause, propose corrective and preventive action plans, track and manage individual actions and measure effectiveness to ensure the root cause has been eliminated.
Implementing a CAPA program as part of the broader quality management system (QMS) improves the tracking and trending of key quality drivers and resulting actions.
While many organizations strive to implement this approach, only those with an effective quality management solution are completely able to do so.
Yes, you can download a PDF version of the course catalog.
Yes, you can contact Customer Support at spartacare@honeywell.com.
Yes, here are the telephone numbers for various regions where Sparta has customers.
You can reach the Sparta Systems Community Portal here.
Here are a few more notes before you sign up. Discount offers cannot be combined. The Company is responsible for all taxes, charges, and duties applicable to the transaction, including without limitation any sales, use, value-added, and/or withholding taxes imposed by any federal, state, provincial, local, or other government entity, excluding taxes based on Sparta’s net income. If Sparta is obligated to collect taxes, then the appropriate amount will be added to the Company’s invoice.