The calibration of instrumentation, devices and equipment, along with many other functions performed during the manufacture of finished pharmaceutical products, are mandated within the FDA's Code of Federal Regulations Part 211 (Current Good Manufacturing Practice For Finished Pharmaceuticals). These labor-intensive complex technical functions generate an avalanche of paper that by its very nature is subject to error and delay. The generally accepted interpretation of the FDA's compliance imperatives and GAMP Good Practice Guide for Calibration Management (through ISPE, International Society for Pharmaceutical Engineering) demands that pharmaceutical manufacturers establish robust calibration systems.
Did you find this white paper useful?
19 out of 43 users found this white paper useful
Related white papers
Balancing Security Against Productivity
What makes for great security? Is it about keeping the bad guys out or letting the good guys in? About defending attacks or preventing them? When IDG Research Services queried...
Web application security: automated scanning versus manual penetration testing
Web sites are vulnerable to Web application attacks and a great percentage of these attacks occur over the HTTP/S protocols, ports that are often exposed to the entire online community....
Novell Zenworks Endpoint Security Management: Total Control from a Single Console
Still super gluing your USB ports shut? Unauthorized access to networks, lost or stolen laptops and other mobile hardware, and theft of proprietary information or intellectual property accounted for more...
Secure Desktop On-Demand Webcast
The desktop or endpoint is one of the most vulnerable parts of your environment. Threats are everywhere. You have users who love to experiment with device settings (only to wonder...
Writing Secure Code - Threat Defense (Part 3 of 3) - Level 200
This webcast discusses memory issues, buffer overruns, heap overruns and how to defend your code against them. Further discussed are memory issues, buffer overruns, heap overruns and how to defend...
Identity and Access Management - Level 200
Identity management solutions can be used to create and manage user account information efficiently and securely across multiple systems within an enterprise. Learn how identity information may be shared and...
Commercial Leasing Company Increases Security With Desktop Operating System Solution
Signature Capital provides customized vehicle and equipment financing packages to meet the specific financial needs of its clients. As a small startup company, Signature Capital was lacking the resources it...
