Translate
One of the biggest challenges medical device companies encounter each day is maintaining the document control compliance the FDA demands. What makes this task particularly challenging is that new developments in medical device technology require the FDA to adapt and change document control requirements frequently. It’s become a vicious cycle, particularly for medical device companies struggling to maintain locally-stored spreadsheets and even file cabinets loaded with paper documentation.
DocXellent's secure, ENSUR document management software system can help you get your medical device document control situation covered in the following four ways:
- ENSUR Document Management System Saves Time with Audits
The ENSUR document management system for medical device companies was designed with FDA document control compliance and auditing needs in mind. A comprehensive DHR can be compiled quickly from testing reports, data sheets, checklists, previous audit findings, system configurations, and unique reports. That way all requested data is consolidated into a report that tags all actions, modifications, and responsible parties in one place. Data that used to take hours to track down for audits can be collected in one place and in just a few moments with ENSUR.
- ENSUR Medical Device Document Control Software Helps You Cull Non-Compliant Devices Quickly
Human error is something every organization lives with daily, but when it comes to medical devices, the fewer human or device error incidents, the better. This is why ENSUR medical device document control software makes finding, tracking, and taking preventative or corrective actions more efficient. Non-conforming products are tagged by defined system controls in the incident tracking system. Whether the non-conforming product is found in house or through customer complaint, ENSUR provides efficient management of the CAPA, through the entire CAPA lifecycle. ENSUR manages the entire review process, analysis factors, approval, implementation measures, acceptance, and then, verification. ENSUR has an independent workflow system that ushers any complaints and incidents of non-compliance through all of the procedures to ensure quick and efficient resolution for better safety and customer satisfaction.
- ENSUR Medical Device Document Control Improves Employee Training
ENSUR also handles one of the most critical means of reducing non-compliance situations: comprehensive training on all levels. Not only does the document management software include training modules that can be tailored to specific employee job titles, but each document that requires training can be connected to a customized quiz module that verifies how well the training was received. Training modules are recorded, collected, and managed entirely through the ENSUR system, including both internal and off-site training moments. Each employee’s training progress is recorded and tracked through the document control software, so managers can assist each employee in their journey to reducing non-compliance issues.
- ENSUR Document Management Software Helps Keep Your Documents Under Control, and Fast
Medical device companies still using paper or locally-stored electronic spreadsheets cite time as one of the biggest hurdles they have when adopting a more manageable, secure, cloud-based document management software. Fortunately, DocXellent has a tested team that’s ready to work with your IT department on OQ Validation scripts to make the whole process quick and easy.
Learn more about how the ENSUR document management system can help you sail over the hurdles of FDA compliance—request a demo today.