Electronic Record Keeping : Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

個数:

Electronic Record Keeping : Achieving and Maintaining Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164

  • 提携先の海外書籍取次会社に在庫がございます。通常3週間で発送いたします。
    重要ご説明事項
    1. 納期遅延や、ご入手不能となる場合が若干ございます。
    2. 複数冊ご注文の場合、分割発送となる場合がございます。
    3. 美品のご指定は承りかねます。
  • 【入荷遅延について】
    世界情勢の影響により、海外からお取り寄せとなる洋書・洋古書の入荷が、表示している標準的な納期よりも遅延する場合がございます。
    おそれいりますが、あらかじめご了承くださいますようお願い申し上げます。
  • ◆画像の表紙や帯等は実物とは異なる場合があります。
  • ◆ウェブストアでの洋書販売価格は、弊社店舗等での販売価格とは異なります。
    また、洋書販売価格は、ご注文確定時点での日本円価格となります。
    ご注文確定後に、同じ洋書の販売価格が変動しても、それは反映されません。
  • 製本 Hardcover:ハードカバー版/ページ数 384 p.
  • 言語 ENG
  • 商品コード 9780849321641
  • DDC分類 070.57970973

Full Description

The current revolution in software, and the regulations that have evolved to address it, have increasingly caused companies to turn to off-the-shelf software for electronic record keeping. Data captured in computerized systems must be as reliable, if not more so, than data on paper. Electronic Record Keeping: Achieving Compliance with 21 CFR Part 11 and 45 CFR Parts 160, 162, and 164 explores how to evaluate, select, implement, and document an e-system that will keep your organization in compliance.

Covering Title 21 of the Code of Federal Regulations (CFR) Part 11 and the parallel, recently passed Title 45 CFR Parts 160, 162, and 164 of the Health Insurance Portability and Accountability Act (HIPAA), this book provides guidance for selecting, purchasing, installing, validating, and managing commercial off-the-shelf software for data collection and retention. It takes a number of years for industry standards for a new regulation to develop from dialog between companies and the regulating agency. These standards are in place for Part 11, which was passed into law in 1997. Healthcare providers who must implement electronic record keeping can learn how to best do it by understanding the parallel between the new HIPAA regulations and the industry standards for Part 11. Further, certain FDA-driven activities, such as patient record keeping in clinical trials, now must comply with the new HIPAA regs as well. To help companies achieve and maintain compliance, the authors cover audit trails, validation, documentation, training, and security and accountability. They discuss what the regulations say and what they mean.

Compliance may be mandatory, but it also makes good business sense. Companies that are compliant will always be poised to move forward, and they will avoid the grief that comes from poor or faulty record keeping and documentation. This book gives you the tools you need to keep your company both compliant and competitive.

Contents

Electronic Record Keeping: The Big Picture. The Regulations: Not Just What They Say, but What They Mean. Going Electronic: What You Need to Know and Do. Documentation and Training. Security, Accountability, and Change Management. Auditing Electronic Record Keeping Systems. Moving Forward. Frequently Asked Questions.