Pharmaceutical Regulatory Documents CD-ROM A Reference of Federal Documents Pertaining to Major Pharmaceutical, Medical Device, Sales, Manufacturing, Electronic ... Included, As An Aid to Compliance

This indispensable reference CD enables you to have the most important pharmaceutical and medical device documents from the federal government available in one convenient CD ROM that installs onto your hard drive. The search feature enables you to search all documents at one time. The CD includes the following categories of FDA and OIG documents: clinical trials, protection of human subjects, IRBs (Institutional Review Boards), Part 11 and computer validation, manufacturing, sales and marketing, FDA procedures, and food additives. The following HIPAA documents are included because they are important for all companies in healthcare: HIPAA Act of 1996, the final rules for privacy, security, and code sets, important federal guidance on the interpretation of the rules, and parts 160, 162, and 164 of section 45 of the Code of Federal Regulations. Altogether, the CD has thousands of pages of documents. You must have Internet Explorer 4.0 or higher running on your computer. Supported operating systems are Windows 95, 98, 98 SE, ME, 2000, or XP. You will need Internet access to e-mail us your unique key and receive a password key. License is for one user on one computer. An additional computer owned by the same user will generally be approved at the discretion of the publisher.