Today's medical device organizations must balance the need to innovate with the need to control processes based on the FDA Quality System Regulation (QSR) and the Medical Device Directive (MDD). To achieve a competitive advantage, you must generate a constant stream of new ideas, deliver on time, and increase profitability while remaining constantly vigilant to safety and compliance requirements. An integrated quality management system is your business imperative.
GxP Partners solutions help to foster innovation within your organization while maintaining a primary focus on safety, efficacy, and security. We've made it our business to navigate the requirements set forth in the QSR and ISO as well as guidelines for Medical Device Reporting (MDR), Medical Device Tracking, Corrections and Removals, and Registration and Listing.
GxP Partners is your ideal technology solutions partner if:
- You need to assess the various CAPA and complaint handing systems available and determine the best approach
- You need a cost effective way to manage the quality audit process, assessment activities, and validation
- Your processes for managing device master records (DMRs) and device history records (DHRs) have not been supported with a robust, industry-specific document control system
- Acceptance activities have not been handled consistently and efficiently, with proper audit trails and electronic signatures required when needed
- You must establish and implement procedures to ensure that equipment is routinely calibrated
- Your noncompliance issues are related to insufficient employee education, background, training, and experience – or to tracking and reporting that the relevant training indeed has been completed
- Any lack of the proper marketing clearance for new intended uses or misbranding could have been prevented with improved document management
GxP Partners can help you ensure that the proper controls are in place for the scrutiny of the Quality System Inspection Technique (QSIT). The technology solutions that we offer are also in keeping with the Process Analytical Technology (PAT) Initiative, which according to the FDA, is based on the understanding that "quality cannot be tested into products; it should be built-in or should be by design."
At GxP Partners, we know about managing electronic records and signatures based on the regulations, the nature of the process, and the quality and safety risks. We know how to apply security measures for both high-impact and low-impact records. Plus we know when and how the integrity of your business information can be protected through configuration management, system validation, change control, and security features.