First in meeting QC production needs, the QCTest software system was developed as a quality control tool to specifically meet the demands of QC performance testing heart valves (function testing). Meeting the highest levels of Validation, this production tool enables you to provide fast, reliable results, for a fraction of the cost it would take to design and validate an in-house system. QCTest is tailored to measure valve performance for disposition in accordance with regulatory requirements. QCTest is built to meet most production needs, to include security, risk management, simplified user interface, error checking, control steps and standard disposition outputs. The software is scalable to include interfacing with various electronic DHR systems and bar code reading. QCTest function test software is source code developed, meeting validation requirements outlined in the FDA General Principles of Software Validation; Final Guidance for Industry, document.
The ViVitro QCTest program is the only turnkey validated function test software system available. When user site testing is performed, a fully validated program is production ready to disposition heart valves for performance. The software can be paired with a modified ViVitro pulse duplicator for quick valve change-out and ease of use or a complete customized automated system can be developed. Either way, ViVitro can provide a turn-key solution for one of the most time-consuming and burdensome systems to validate. QCTest operated through a USB Multifunction Measurement and Control Board, compatible with the latest 64-bit operating systems.
QCTest software from ViVitro Labs features:
Data Acquisition and Control System:
- Step-by-step wizard walks you through calibration process
- Error checking verifies calibration and analysis avoiding erroneous data
- Multifaceted algorithms automatically analyzes data
- All elements of the program are logged for security and legacy
- Reports are formatted for production
- Each operation is verified for correct step by step operation
- Tester operation is controlled by input control statements
- Administrator controls and creates valve disposition criteria, operating acceptance limits, and access
- Data is integrated for accuracy, ensuring validated results.
.Net 3 Platform
Configured for 64-bit Windows 7 operating systems
Source code created system for completely validated software
Certificate of Conformity provided. Validation documents are made available.
The ViVitro QCTest software was developed in a certified ISO 13485 facility and meets applicable IEC and ISO software VV&T requirements and FDA General Principles of Software Validation.
For more information about how QCTest software or ViVitro’s engineering staff can assist you with Function Testing to meet your Quality Control needs, please contact us.