Achieving Regulatory Compliance over Files and Directories for a Medical Device Provider with Xybion's Compliance Builder solutions
Achieving Regulatory Compliance over Files and Directories for a Medical Device Provider with Xybion's Compliance Builder solutions
2 PagesCase Study Achieving Regulatory Compliance over Files and Directories for a Medical Device Provider with Xybion's Compliance Builder solutions Company Overview Company Global leader in providing healthcare solutions in orthopedics, spinal care, sports medicine and neurosciences. Industry Medical Device Geography United States Key Business Challenges • Need to lock information • Comply with FDA 21 CFR Part 11 • File change notifications • Maintain Data Integrity • Electronic Signature • Create Audit Trail • Restrict Access • Integrated monitoring system with equipment • Product Report • Identify changes in data • Push data to reports • Work with existing IT Infrastructure COMPANY A global medical device provider of healthcare solutions in orthopedics, spinal
