24

Oct

2007

SoftwareCPR 21 CFR Part 11 Reference Manual$

0

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21 CFR Part 11 is a topic of current focus for FDA and industry. This manual contains the most important FDA documents related to Part 11 as well as some key SoftwareCPR educational Aides as listed below:

This manual was updated on 10/24/2007 to reflect the Part 11 changes and redirection.

-FDA Electronic Records; Electronic Signatures Part 11 No Preamble
-FDA Part 11 Redirection and Guidance Notice
-FDA Part 11 Electronic Records; Electronic Signatures – Scope and Application
-FDA Electronic Records; The New Draft Guidance; A Redirection – Presentation March 19, 2003

-SoftwareCPR Training Aide on FDA Part 11 Redirection Feb 2003
-FDA ORA CPG 7348.08 BIMO Attachment A – Computer System-Part 11
-AABB Book Alan Kusinitz – Part 11 Chapter
-SoftwareCPR Part 11Rule and Preamble Side-by-Side
-SoftwareCPR Part 11 Software Assessment Job Aide
-FDA OMB QS Regulation Record Keeping Requirements
– SoftwareCPR QSR Signatures
– SoftwareCPR Drug GMP Signatures
-FDA ORA IOM Chapter 5 Electronic Records Excerpt
-FDA Computerized Systems Used in Clinical Trials
-SoftwareCPR Clinical Trials Software Full Checklist
-FDA 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule – With Preamble

The pdf file includes bookmarks and a clickable Table of Contents. View the manual here: SoftwareCPR-Part 11 Reference Manual

We hope you find this Part 11 reference manual useful. If you have any suggestions leave us a message below:

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