Compliance Software
Better Healthcare Through Better Data Management
It's not surprising that state-of-the-art healthcare systems generate huge volumes of information.
10 most common nonconformance mistakes
To help medical-device companies better understand the requirements associated with gaining regulatory approval of their new product introductions, the FDA has identified the 10 most common deficiencies that result in indications of noncompliance...
Finally, medical records for the 21st century
Where are your medical records? If you're like me, they are probably on paper scattered across the country in several hospitals, doctor offices, and military warehouses. In other words, they are absolutely useless....
Software Improves Company Compliance, and More
After recognizing that its home-grown data systems were inefficient, insecure, and non-compliant with 21 CFR Part 11, imaging-equipment manufacturer ACIST...
Better Healthcare Through Better Data Management
It's not surprising that state-of-the-art healthcare systems generate huge volumes of information....
PLM tames FDA tasks
The Medical Device Template inside Windchill PDMLink from PTC Inc., Needham, Mass., (ptc.com ) let a medical-device maker trace and record product data...
Software Assists With Regulation Compliance
Osmetech Molecular Diagnostics, Roswell, Ga., (osmetech.com), a manufacturer of diagnostic equipment, purchased SmartCAPA, SmartComplaints, and SmartDoc...
Ideas for Validating Production Software
The FDA requires medical-device manufacturers to validate software that is part of production or a quality system. But what does that mean? Those charged...
Three Steps to Electronic Records
Medical device and equipment companies are challenged with controlling, managing, and distributing product information in a structured and secure environment....
