CFR Part 11 / GXP Issues
Title 21 CFR Part 11 of the Code of Federal Regulations outlines Federal Drug Administration (FDA) guidelines on electronic records and electronic signatures and the criteria that determine whether they are considered trustworthy and reliable. Pharmaceutical manufacturers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries must comply with standards for their IT systems.
For a drug or other item regulated by the FDA to be GxP compliant, everything that contributes directly or indirectly to its development, manufacturing and handling must be GxP compliant. If you're in an FDA regulated business, that includes your information system.
Our experienced consultants know the ins and outs of these regulations and standards. They can help you develop processes and systems that keep you in compliance while reducing your administrative cost and cutting down on necessary paperwork.
Global Trade Case Studies
CA Automates Global Trade Process
The Story of the GTS 7.0 Upgrade at NVIDIA
The Story of the GTS Implementation at Applied Biosystems
CFR Part 11 / GXP Issues
Title 21 CFR Part 11 of the Code of Federal Regulations outlines Federal Drug Administration (FDA) guidelines on electronic records and electronic signatures and the criteria that determine whether they are considered trustworthy and reliable. Pharmaceutical manufacturers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries must comply with standards for their IT systems.
For a drug or other item regulated by the FDA to be GxP compliant, everything that contributes directly or indirectly to its development, manufacturing and handling must be GxP compliant. If you're in an FDA regulated business, that includes your information system.
Our experienced consultants know the ins and outs of these regulations and standards. They can help you develop processes and systems that keep you in compliance while reducing your administrative cost and cutting down on necessary paperwork.
Global Trade Case Studies
CA Automates Global Trade Process
The Story of the GTS 7.0 Upgrade at NVIDIA
The Story of the GTS Implementation at Applied Biosystems