How to enhance CAPA processes in medical device manufacturing with Teamcenter Quality
Advanced digital technology has helped the medical device industry improve patient outcomes and uphold safety standards. However, this progress can meet roadblocks when it comes to extensive documentation and regulatory approval requirements.
That’s why manufacturers must prioritize continuous improvement and advancement in quality processes to drive product development, reduce risks and improve patient safety.
To move to a more efficient closed-loop quality and compliance approach, it is crucial to develop a strategy that focuses on continuous improvement to enhance standards and innovation.
Overcoming CAPA challenges in the medical device industry
Stringent guidelines are recommended for corrective and preventive action (CAPA) implementation, but medical device manufacturers often struggle with inefficient processes, which can lead to compliance gaps.
An effective CAPA process cannot be managed in isolation but must be part of a broader quality management system (QMS). Because a QMS is so important, Siemens has developed Teamcenter Quality to help MedTech companies streamline core processes, expedite market submissions and continually improve products.
Teamcenter Quality is with you at every phase of quality improvement
Teamcenter Quality delivers capabilities for capturing quality issues, customer complaints and nonconformances to support a formal process and systematically investigate, analyze and resolve quality issues, streamline the definition of measures to prevent recurrences and report the results in a clear and intuitive manner.
Below are just some of the tasks in Teamcenter Quality that users can perform to improve efficiency in each step of CAPA workflows for process information, review, escalation and approval.
- Create a CAPA process without going through the issue investigation stage
- Track associated projects, events, schedules, supplier information and customer information
- Easily select the right personnel and assign appropriate roles
- Use historical data to determine if there are existing reaction plans to cross-reference for validation
- Brainstorm with multidimensional root-cause analysis
- Analyze performance based on available default active summary reports
- Automatically check impacted items that are related to a common problem
Ensure quality-driven lifecycle management
By taking advantage of Teamcenter Quality, medical device manufacturers can accelerate their digital transformation and achieve quality excellence.
Pursuing a continuous improvement approach promotes a culture of quality and compliance in organizations. Faster closure rates, enhanced audit readiness and data-driven decision-making lead to enhanced operational effectiveness, driving better outcomes across your entire organization.
Teamcenter Quality is part of the Siemens Closed Loop Quality and Compliance for medical devices portfolio, which tracks required data to continuously address quality processes, efficiency and helps improve interactions with health authorities.
For greater detail of Teamcenter Quality’s capabilities for continuous improvement in the medical devices industry, read the full white paper.
