With a Presidential Executive Order on cybersecurity in effect, and FDA taking an interest in computers, software and integrity of data, WIS has decided to compile an array of FDA and international guidance documents and standards on software, computers and cybersecurity.
Our "FDA Computer/Software and Cybersecurity Manual" (first edition) compiles valuable documents and guidance from FDAs Office of Regulatory Affairs, and Centers for Devices, Drugs and Biologics, so executives will benefit from knowing how each of FDAs three therapeutic product centers treat validation and verification of computerized systems used in manufacturing, in addition to product submissions to FDA.
And, we are adding important documents related to cybersecurity.
The First Edition of the FDA Computer/Software and Cybersecurity Manual contains more than 800 pages of the following, plus a valuable CD:
Examples of 483, EIR and warning letter citations on electronic records and computer and software validation
Cybersecurity and devices, including Executive Order and NIST standard development
FDA and EU computer and software validation guidance documents
Guidance on clinical trials and electronic adverse event reporting
Guidance on the electronic signature and records rule (Part 11)
A list of international standards for medical software and computers used in the processing of drugs, devices and biologics
Recommended publications and Web sites to go to for computer validation information
Important articles from our publications on FDA and international regulation of computer/software issues
No maker of drugs, devices and biologics should be without the FDA Computer/Software and Cybersecurity Manual. Avoid problems in inspections and stay in compliance. Ensure your product integrity is in tact -- Order this manual and save 30 percent!
We also will throw in a CD of various articles and guidance on cybersecurity, software and computer validation.
NOW JUST $325 PLUS SHIPPING UNTIL THE END OF THE YEAR!